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Sample records for chemotherapy prospective randomized

  1. Prospective randomized study on inductive chemotherapy plus radiotherapy for patients with upper and middle esophageal carcinoma

    International Nuclear Information System (INIS)

    Objective: To evaluate the effect of radiotherapy combined with inductive chemotherapy for patients with upper and middle esophageal cancer. Methods: 162 patients with upper and middle esophageal cancer were randomized into two groups, with 82 treated by inductive chemotherapy combined with radiotherapy (C + R) and 80 by radiotherapy alone (R). The chemotherapy regimen included 5-fluorouracil 500 mg/m2 on d1-d5 by continuous infusion for 120 hours, cisplatin 60 mg/m2 on dl and bleomycin A5 8 mg on d1, d3, d5 intravenously. Three to seven days after chemotherapy, the patients were irradiated with anteroposterior (AP) and posteroanterior (PA) fields to a dose of 40-44 Gy in 4.0-4.4 weeks followed by a boost of 24-28 Gy in 2.4-2.8 weeks through oblique fields. Results: The 5- and 10-year survival rates were 22.0%, 15.9% for the C + R group and 13.8%, 8.8% for the R group. The difference was statistically significant (P = 0.034). The toxic and side effects were tolerable and similar in the two groups. Nineteen patients (23%) in the C + R group and thirty-one (39%) in the R group died from distant metastasis and/or lymph node metastasis, even though the difference was not statistically significant (x2 = 3.47, P > 0.05). Conclusions: Inductive chemotherapy with 5-fluorouracil, cisplatin, bleomycin A5 plus radiotherapy may improve the outcome of esophageal cancer, with the toxic and side effects of the combined modality severer than radiation along, but they are well tolerated

  2. A Prospective Randomized Study of Adjuvant Chemotherapy in Completely Resected Stage Ⅲ-N2 Non Small Cell Lung Cancer

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Objective: To evaluate the effect of postoperative adjuvant chemotherapy on survival after complete resection of stage Ⅲ-N2 non-small-cell lung cancer. Methods: From Jan. 1999 to Dec. 2003, one-hundred and fifty patients, who were diagnosed as stage Ⅲ-N2 non-small cell lung cancer after operation, were randomly devided into chemotherapy group and control group. The former received four cycles of chemotherapy with NVB (25 mg/m2,D1, D5)/paclitaxel (175 mg/m2, DI) and Carboplatin (AUC=5, D1). Results: In chemotherapy group, 75.8% (68/79) of patients had finished the 4 cycles of chemotherapy and no one died of toxic effects of chemotherapy.Twenty-five percent of the patients had grade 3-4 neutropenia and 2% had febrile neutropenia. The median survival for the entire 150 patients was 879 d, with 1-year survival rate of 81%, 2-year survival rate of 59% and 3-year survival rate of 43%. There was no significant difference in median survival between chemotherapy and control group (897 d vs 821 d, P=0.0527), but there was significant difference in the 1-year and 2-year overall survival (94.71%, 76.28% vs 512 d, P=0.122), but there was significant difference in the 2-year survival rate between two groups with brain metastases (66.7% vs 37.6% P<0.05). The median survival after brain metastasis appeared was 190 days. Conclusion: Postoperative adjuvant chemotherapy does not significantly improve median survival among patients with completely resected stage Ⅱ-N2 non-small-cell lung cancer, but significantly improves the 1-year and 2-year overall survival. It neither decreases the incidence of brain metastasis but put off the time of brain metastasis.

  3. A prospective and randomized study of radiotherapy, sequential chemotherapy radiotherapy and concomitant chemo therapy-radiotherapy in unresectable non small cell carcinoma of the lung

    Directory of Open Access Journals (Sweden)

    Dasgupta Anirban

    2006-01-01

    Full Text Available Purpose: Treatment of advanced Non small cell lung cancer (NSCLC often produces dismal results. Combination of available treatment modalities has reportedly improved the outcome. A prospectively randomized trial was conducted, comparing combined treatment modalities versus radiotherapy alone, in treatment of unresectable NSCLC. Materials and Methods: A total of 103 patients were randomized to three groups. In group ′A′, 32 patients received radiotherapy alone (6500 cGy/30 fraction. In group ′B′, 35 patients received neoadjuvant chemotherapy (Cisplatin 80 mg/m2 on day 1 and Etoposide 100 mg/m day 1-3 intravenously q3 weeks for 3 cycles, followed by radiotherapy (6000 cGy/30 fractions and 3 more cycles of Chemotherapy, with the same regimen. In group ′C′, 36 patients received radiotherapy (5000 cGy/25 fractions with concurrent chemotherapy (ciplatin 20 mg/m2 + Etoposide 75 mg/m2 intravenously on day 1-5 and day 22-26, followed by 2 more cycles of chemotherapy,q3 weeks with the same regimen. Results: Initial treatment responses were significantly higher in group ′B′ ( P P Conclusion: Addition of chemotherapy with radiation in unresectable NSCLC improves response rates, time to tumour progression and disease free survival, though the same effect is not translated in overall survival.

  4. Preliminary Results of a Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma in Endemic Regions of China

    International Nuclear Information System (INIS)

    Purpose: A prospective randomized trial was performed to evaluate the efficacy of concurrent chemotherapy and adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC) in endemic regions of China. Methods and Materials: Between July 2002 and September 2005, 316 eligible patients were randomly assigned to receive either radiotherapy alone (RT) or chemoradiotherapy concurrent with adjuvant chemotherapy (CRT). All patients received 70 Gy in 7 weeks using standard RT portals and techniques. The CRT patients were given concurrent cisplatin (40 mg/m2 on Day 1) weekly during RT, followed by cisplatin (80 mg/m2 on Day 1) and fluorouracil (800 mg/m2 on Days 1-5) every 4 weeks (Weeks 5, 9, and 13) for three cycles after completion of RT. All patients were analyzed by intent-to-treat analysis. Results: The two groups were well-balanced in all prognostic factors and RT parameters. The CRT group experienced significantly more acute toxicity (62.6% vs. 32%, p = 0.000). A total of 107 patients (68%) and 97 patients (61%) completed all cycles of concurrent chemotherapy and adjuvant chemotherapy, with a median follow-up time of 29 months. The 2-year overall survival rate, failure-free survival rate, distant failure-free survival rate, and locoregional failure-free survival rate for the CRT and RT groups were 89.8% vs. 79.7% (p = 0.003), 84.6% vs. 72.5% (p = 0.001), 86.5% vs. 78.7% (p = 0.024), and 98.0% vs. 91.9% (p = 0.007), respectively. Conclusions: This trial demonstrated the significant survival benefits of concurrent chemotherapy plus adjuvant chemotherapy in patients with locoregionally advanced NPC in endemic regions of China

  5. Prospective randomized trail on chrono-chemotherapy + late course three dimensional conformal radio-therapy and conventional chemotherapy plus radiotherapy for nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Objective: To compare the therapeutic effects, toxic side effects of late-course three dimensional conformal radiotherapy plus chrono-chemotherapy (DDP + 5-FU/CF) and conventional radiotherapy plus chemotherapy for nasopharyngeal carcinoma (NPC). Methods: Eighty -six NPC patients admitted from Feb. 2001 to Jan. 2002 were divided randomly into two groups: 1. Chrono-chemotherapy + late course three dimensional conformal radiotherapy(CCR) group-44 patients were treated by late course three dimensional conformal radio-therapy plus chrono-chemotherapy, and 2. Routine-chemotherapy-radiotherapy (RCR) group-42 patients were treated by routine chemotherapy plus radiotherapy. The patients in CCR and RCR group were comparable in age, KPS, stage and pathology. All patients were treated by combined chemotherapy and radiotherapy, with chemotherapy stared 2 weeks ahead of radiotherapy. Chemotherapy: Braun pump was used in all drug infusions; 1. CCR group-DDP 80 mg/ m2 starting from 10:00 until 22:00, 5-Fu 750 mg/d/m2 starting from 22:00 until 10:00 next day, CF 200 mg/d/m2 starting from 10:00 every day, infused at normal speed. These drugs were given for 3 days, 14 days as one cycle, totally 2 cycle, and 2. RCR group-with the same drugs at the same total dose, only with the difference being DDP and CF given QD, starting from 10:00 but at the normal speed. 5-Fu was given through-out the day and continuously for 3 days, totally for 2 cycles. Radiotherapy: linear accelerator irradiation was given to either group. Composite facio-cervical field + anterior cervical tangential field to DT 40 Gy/4w, followed by the coned down per-auricular field plus anterior tangential field or β beam irradiation. In CCR group, after DT 40gy/4w, late course 3-dimensional conformal radiotherapy (3DCRT) was used to add DT 30Gy/3w. In RCR group, routine radiotherapy of 40 Gy/w was supplemented with 30 Gy/3w. The total dose in either group was 70 Gy/7w at the nasopharynx, DT60-70 Gy/6-7w at the neck, as

  6. [Reducing the side effects of aggressive chemotherapy (cisplatin and epirubicin) with xenogenic peptides (factor AF2) in patients with hormone refractory metastatic prostate cancer. A prospective, randomized study].

    Science.gov (United States)

    Papadopoulos, I; Wand, H

    1989-06-01

    The indication of a chemotherapy is advisable with patients who are suffering from a progressively metastasised, secondarily hormone refractory carcinoma of the prostate. In search of efficient chemotherapy protocols we combined cisplatin with epirubicin (PE scheme) in our clinic. Massive side effects of that aggressive chemotherapy scheme like gastro-intestinal trouble and myelotoxicity are the limiting factors of the scheme. With measures like reducing the dosage, delaying the next cycle, or breaking off the therapy the effective dosage can often not be achieved. The anti-emetics which are usually used today exclusively give anti-emetic protection. The additional administration of xenogenic peptides (Factor AF2) had additionally myeloprotective effect in former studies. In this study we examined whether, by additionally giving Factor AF2, the patients' subjective condition, and above all their hemogram, could be stabilised in order to achieve the effective dosage or dosage intensity. For that, the patients were prospectively randomised in two groups by means of a random selection board. The analysis of the data gained in the protocol showed that the additional administration of Factor AF2 improves the patients' subjective conditions significantly. Apart from that, we noticed a considerable reduction of the vomiting frequency. Concerning the objective measured parameters of the leukocytes, thrombocytes, erythrocytes, and the hemoglobin level, the significantly myeloprotective effect of Factor AF2 could be proved. Due to the fact that in the verum group there were considerably fewer cases of breaking off or delays of the treatment than in the control group, the effective dosage intensity could be achieved with a higher number of patients in that group. PMID:2691943

  7. Thoracic and elective brain irradiation with concomitant or delayed multiagent chemotherapy in the treatment of localized small cell carcinoma of the lung: a randomized prospective study by the Southeastern Cancer Study Group

    International Nuclear Information System (INIS)

    A prospective randomized study was carried out to compare the effectiveness of concomitant or delayed multiagent chemotherapy combined with irradiation to the primary tumor and regional lymph nodes and to the brain in a group of 70 patients with histologically proven small cell undifferentiated carcinoma of the lung. Complete and partial response in both groups was comparable, and the overall survival was comparable. However, relapse-free survival was significantly higher in patients receiving concomitant chemotherapy and irradiation in comparison with the radiotherapy alone group. Disease-free survival was higher in the concomitant chemotherapy-radiotherapy patients, although survival was not significantly modified, probably because of suboptimal chemotherapy. The incidence of distant metastasis was slightly lower in the chemotherapy groups. Brain metastases were noted in 7% of the patients in both groups. Increased intrathoracic recurrences were noted in patients with lower doses of irradiation. The study emphasizes the need for intensive chemotherapy and adequate radiation therapy to improve survival of patients with small cell undifferentiated carcinoma of the lung

  8. Impact of the prophylactic gastrostomy for unresectable squamous cell head and neck carcinomas treated with radio-chemotherapy on quality of life: Prospective randomized trial

    International Nuclear Information System (INIS)

    Background and purpose: Concomitant radio-chemotherapy is the gold standard treatment for unresectable head and neck carcinomas. Placement of prophylactic gastrostomy has been proposed to provide adequate nutrition during the therapeutic sequence. The objectives of this study were to assess the impact of prophylactic gastrostomy on the 6-month quality of life, and to determine the factors related to this quality of life. Materials and methods: Design. randomized, controlled, open study ('systematic percutaneous gastrostomy' versus 'no systematic gastrostomy'). Patients. squamous cell head and neck carcinoma (stages III and IV, UICC 1997). Setting. oncological departments of French university teaching hospitals. Treatment. optimal concomitant radio-chemotherapy. Evaluations. T0 baseline evaluation, T1 during the treatment, T2 end of the treatment, and T3 6-month post-inclusion. Primary endpoint. 6-month quality of life (Qol) assessed using SF36, EORTC QLQ-C30, EORTC QLQ H and N35 questionnaires. Results: The Qol changes from baseline included a decline (T1 and T2) followed by an improvement (T3). Qol at 6 months was significantly higher in the group receiving systematic prophylactic gastrostomy (p = 10-3). Higher initial BMI and lower initial Karnofsky index were significant factors related to a higher 6-month Qol. Conclusions: The study results suggest that prophylactic gastrostomy improves post-treatment quality of life for unresectable head and neck cancer patients, after adjusting for other potential predictive quality of life factors.

  9. The treatment of soft-tissue sarcomas of the extremities - prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy

    International Nuclear Information System (INIS)

    Between May 1975 and April 1981, 43 adult patients with high-grade soft tissue sarcomas of the extremities were prospectively randomized to receive either amputation at or above the joint proximal to the tumor, including all involved muscle groups, or to receive a limb-sparing resection plus adjuvant radiation therapy. The limb-sparing resection group received wide local excision followed by 5000 rads to the entire anatomic area at risk for local spread and 6000 to 7000 rads to the tumor bed. Both randomization groups received postoperative chemotherapy with doxorubicin (maximum cumulative dose 550 mg/m2), cyclophosphamide, and high-dose methotrexate. Twenty-seven patients randomized to receive limb-sparing resection and radiotherapy, and 16 received amputation (randomization was 2:1). There were four local recurrences in the limb-sparing group and none in the amputation group (p1 = 0.06 generalized Wilcoxon test). However, there were no differences in disease-free survival rates (83% and 88% at five years; p2 = 0.99) between the limb-sparing group and the amputation treatment groups. Multivariate analysis indicated that the only correlate of local recurrence was the final margin of resection. Patients with positive margins of resection had a higher likelihood of local recurrence compared with those with negative margins (p1 1 = 0.00008) and overall survival (95% vs. 74%; p1 = 0.04)

  10. A pilot study to assess the feasibility of evaluation of markers of response to chemotherapy at one day & 21 days after first cycle of chemotherapy in carcinoma of breast: a prospective non-randomized observational study

    Directory of Open Access Journals (Sweden)

    Vijaykumar DK

    2009-03-01

    Full Text Available Abstract Background Interest in translational studies aimed at investigating biologic markers in predicting response to primary chemotherapy (PCT in breast cancer has progressively increased. We conducted a pilot study to evaluate feasibility of evaluating biomarkers of response to PCT at one & 21 days after first cycle. Methods Adult, non-pregnant, non-lactating women with histologically confirmed infiltrating duct carcinoma underwent serial core biopsies after first cycle of PCT and these were scored for Ki-67, Bcl-2 and Caspase-3 using immunohistochemistry. Results We recruited 30 patients with a mean age of 51 years. We were successful 95.6% times in performing a core biopsy and of these 84.6% had adequate tissue in the cores harvested. After a mean of 4 cycles of PCT, 26 patients underwent surgery and good response was noted in 9 patients (30% using Miller-Payne criteria. There was a trend noted in all markers, which appeared different in those with good response and poor response. Good responders had significantly higher Ki-67 and significantly lower Bcl-2 at baseline and a significant decrease in Ki-67 and Caspase-3 at 21 days after the first chemotherapy. Conclusion We report a detectable change in biomarkers as early as 24–48 hours after the first chemotherapy along with a definite trend in change that can possibly be used to predict response to chemotherapy in an individual patient. The statistical significance and clinical utility of such changes needs to be evaluated and confirmed in larger trials.

  11. Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial

    OpenAIRE

    Wilfried Tröger; Zdravko Ždrale; Nevena Tišma; Miodrag Matijašević

    2014-01-01

    Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy. Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the s...

  12. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction – a prospective cohort pilot study within a randomized clinical trial

    International Nuclear Information System (INIS)

    Neoadjuvant therapy for cancer of the esophagus or gastroesophageal (GE)-junction is well established. The pros and cons of chemoradiotherapy and chemotherapy are debated. Chemoradiotherapy might impair cardiac function eliciting postoperative morbidity. The aim of this pilot study was to describe acute changes in left ventricular function following chemoradiotherapy or chemotherapy. Patients with esophageal and (GE)-junction cancer enrolled at our center into a multicenter trial comparing neoadjuvant chemoradiotherapy and chemotherapy were eligible. Patients were randomized to receive cisplatin and 5-fluorouracil with or without the addition of 40 Gy radiotherapy prior to surgery. Left ventricular function was evaluated using echocardiography and plasma N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) before and after neoadjuvant treatment. The primary outcome measure was left ventricular global strain (GS). Clinical effects were assessed using repeated exercise tests. Linear mixed models were used to analyze the effects of treatment group, and the interaction between groups. 40 patients participated (chemoradiotherapy, n = 17; chemotherapy, n = 23). In the chemoradiotherapy group there was no change in left ventricular global strain but mitral annular plane systolic excursion (MAPSE) of the ventricular septum, early diastolic filling velocity (E-velocity), and the ratio of early to late ventricular filling velocities (E/A ratio) decreased significantly (p = 0.02, p = 0.01, and p = 0.03, respectively). No changes were observed in the chemotherapy group. There was a trend towards an interaction effect for MAPSE sept and E (p = 0.09 and p = 0.09). NT-proBNP increased following chemoradiotherapy (p = 0.05) but not after chemotherapy (p > 0.99), and there was a trend towards an interaction effect (p = 0.07). Working capacity decreased following neoadjuvant treatment (chemoradiotherapy p = 0.001, chemotherapy p = 0.03) and was more pronounced after

  13. Hepatic intra-arterial chemotherapy (HIAC) of high dose mitomycin and epirubicin combined with caval chemofiltration versus prolonged low doses in liver metastases from colorectal cancer: a prospective randomized clinical study.

    Science.gov (United States)

    Fiorentini, G; Poddie, D B; Cantore, M; Rossi, S; Tumolo, S; Dentico, P; Bernardeschi, P; Guadagni, S; Rossi, G; Valori, V M; De Simone, M

    2004-11-01

    A multicenter randomized study comparing high dose of mitomycin and epirubicin given as hepatic intra-arterial chemotherapy (HIAC) combined with caval chemofiltration (CF) versus low doses of the same drugs in unresectable liver metastases from colorectal cancer showed a significant improvement in the survival rate of the 20 patients treated with high dose compared to the 22 patients treated with low doses with a 1 year survival of 69% vs 39%. The median survival was 17 vs 11 months and the responses were 65% vs 33%. Toxicity was colangitis in 50% of patients considered. The extrahepatic progression was similar in the two groups (7/20 vs 8/22). PMID:15675479

  14. Overall and event-free survival are not improved by the use of myeloablative therapy following intensified chemotherapy in previously untreated patients with multiple myeloma: a prospective randomized phase 3 study

    NARCIS (Netherlands)

    C.M. Segeren (Christine); P.W. Wijermans (Pierre); S. Wittebol (Shulamit); J.W. Baars (Joke); W.E. Fibbe (Willem); P. Sonneveld (Pieter); B. van der Holt (Bronno); M.M. Steijaert; E. Vellenga (Edo); H.M. Lokhorst (Henk); D.H. Biesma (Douwe); A.J. Croockewit; G.E.G. Verhoef (Gregor); J.J. Cornelissen (Jan); M. van Marwijk Kooy (Marinus); R. Slater (Rosalyn); M.R. Schaafsma (Martijn); I. Buijt; M.H.J. van Oers (Marinus)

    2003-01-01

    textabstractWe compared the efficacy of intensified chemotherapy followed by myeloablative therapy and autologous stem cell rescue with intensified chemotherapy alone in patients newly diagnosed with multiple myeloma. There were 261 eligible patients younger than 66 years with stag

  15. Autologous cytokine-induced killer cells therapy on the quality of life of patients with breast cancer after adjuvant chemotherapy: A prospective study

    Institute of Scientific and Technical Information of China (English)

    梁雪峰

    2013-01-01

    Objective To explore the effect of autologous cytokine-induced killer cells on the quality of life in patient with breast cancer who have already finished the adjuvant chemotherapy.Methods One hundred and twenty-eight postoperative patients with breast cancer who underwent anthracycline-based adjuvant chemotherapy were enrolled in this prospective study,and they were randomized into2 groups,i.e.,treatment group,which received the therapy of CIK cells transfusion,and control group,

  16. Effect of Oral Cryotherapy on Combination Chemotherapy-induced Oral Mucositis: A Randomized Clinical Trial

    OpenAIRE

    Abbas Heydari; Hassan Sharifi; Roham Salek

    2012-01-01

    Background: This study assesses the effect of oral cryotherapy on the incidence and severity of chemotherapy-induced oral mucositis in combined chemotherapy regimens.Methods: This was a randomized controlled trial that enrolled 80 cancer patients. We evaluated the primary oral status of all patients prior to chemotherapy. Patients were divided into two groups, experimental and control. The experimental group was given ice to place in their mouths from 5 min before to 5 min after chemotherapy....

  17. Comparison between systemic radiotherapy, chemotherapy, and local radiotherapy in extended small cell lung carcinoma. Results of randomized series

    International Nuclear Information System (INIS)

    Between 1982 and 1987 a prospective randomized study to compare the effectiveness of high-dosed half-body irradiation (HBI) (A), intensive combined chemotherapy (B), and local or locoregional radiotherapy (C) in extended small cell lung carcinoma (SCLC) was carried out. 99 patients with a histologically proved SCLC were arranged to three therapeutic groups of series: A = 31 patients, B = 37 patients, C = 31 patients. The median survival period showed a statistically significant advantage (p < 0.01) for the chemotherapy group (B = 46 weeks) in comparison to the radiotherapy groups (A = 19 weeks, C = 23 weeks). The survival after half a year, one year, and two years revealed also clear advantages over the chemotherapy group. No difference was found between the radiotherapy groups A and C. The high-dosed HBI did not improve the deplorable therapeutic situation for the extended SCLC. (author)

  18. Pulmonary toxicity after radiotherapy in primary breast cancer patients: results from a randomized chemotherapy study

    International Nuclear Information System (INIS)

    Purpose: Pulmonary toxicity was prospectively evaluated within a randomized trial for breast cancer patients at high risk for relapse, who postoperatively received as adjuvant therapy either 9 cycles of tailored chemotherapy (20 patients) (cyclophosphamide, epirubicin, 5-fluorouracil [FEC]) or standard FEC x 3 followed by high-dose chemotherapy (cyclophosphamide, thiotepa, carboplatin [CTCb]) supported by peripheral blood stem cell transplantation (14 patients). After high-dose chemotherapy or tailored FEC, all patients received locoregional radiotherapy (50 Gy/5 weeks), plus tamoxifen for 5 years. Methods and Materials: Lung function tests (FVC, FEV1, and DLCO) were performed before chemotherapy and 9 months after radiotherapy. Computed tomography of the lungs was performed before radiotherapy and 6 weeks, 3 months, and 9 months after radiotherapy. Results: Clinical signs of suspected pneumonitis were noted in 29% of patients, but only 1 patient needed symptomatic therapy. Radiologic changes were detected in 68% of patients, and they were most frequent at 3 months after radiotherapy. FVC decreased in both groups (tailored FEC: mean difference, -6.5%, p=0.0005; CTCb: -2.0%, p=0.21; tailored FEC vs. CTCb: -4.5%, p=0.05). DLCO decreased significantly in both groups (tailored FEC: mean difference, -11.2%, p<0.0001; CTCb: -5.6%, p=0.02; tailored FEC vs. CTCb: -5.6%, p=0.07). FEV1 decreased by 7.3% in patients treated with tailored FEC (p<0.0001) and by 2.5% in patients treated with CTCb (p=0.03) (tailored FEC vs. CTCb: 3.7%, p=0.08). Conclusions: Changes in pulmonary function were thus detected in both groups, although to a greater extent in the tailored FEC group. The clinical significance of these findings should be balanced carefully against the improved, statistically significant relapse-free survival achieved with the tailored FEC regimen compared to high-dose CTCb + peripheral blood stem cell transplantation (PSCT)

  19. Effect of Chewing Gum on Oral Mucositis in Children Undergoing Chemotherapy: A Randomized Controlled Study

    OpenAIRE

    Eghbali, A.; Taherkhanchi, B; Bagheri, B; Sadeghi Sedeh, B

    2016-01-01

    Background Oral mucositis is an adverse effect of chemotherapy. Type of chemotherapy regimen is the most important factor causing mucositis. Oral mucositis is usually associated with transient decrease in saliva production. The goal was to study effects of gum consumption on oral mucositis in children undergoing chemotherapy. Materials and Method This randomized controlled trial was done in Amir Kabir Hospital, Arak, Iran. 130 children 5 to 15 years of age were studied. Control group was comp...

  20. Prospective trial of radiotherapy after hyperbaric oxygenation with chemotherapy for high-grade gliomas

    International Nuclear Information System (INIS)

    Twenty-one patients with high-grade gliomas were enrolled in a prospective trial of radiotherapy after hyperbaric oxygenation (HBO). Radiotherapy was administered in daily 2-Gy fractions up to a total dose of 60 Gy, and each fraction was delivered immediately after HBO. The current study indicated that radiotherapy immediately after HBO with chemotherapy was feasible for high-grade gliomas

  1. Locoregional first recurrence after mastectomy: prospective cohort studies with and without immediate chemotherapy

    International Nuclear Information System (INIS)

    Purpose: To evaluate prospectively the impact of combination chemotherapy in the combined modality treatment of isolated first locoregional recurrence (LRR) following mastectomy for breast cancer. Methods and Materials: Between 1979 and 1989, 120 chemotherapy-naive women with isolated LRR as first failure after mastectomy were prospectively identified, uniformly staged, and systematically followed. Treatment consisted of excision if feasible, radical locoregional radiotherapy, and a hormonal maneuver (unless estrogen receptor negative). The initial chemotherapy cohort also received 8 cycles of doxorubicin and cyclophosphamide. This was compared to a subsequent control cohort. Results: For all patients, the 10-year actuarial relapse-free survival ± 95% confidence interval was 42.1 ± 9.2%, and overall survival was 56.8 ± 9.1%. No difference was seen in locoregional control between cohorts. At 5 years, distant recurrence-free survival for chemotherapy and control cohort respectively was 75.4 ± 10.8% and 60.7 ±12.5% (p = 0.33) and overall survival was 81.9% ± 9.6 and 74.3% ± 11.2 (p = 0.24). Univariate analysis showed no prognostic importance for any imbalance between cohorts. Cox modeling confirmed that complete resection was strongly associated with fewer LRR (hazard ratio [HR] 0.32, p = 0.001) and also with better overall survival (HR 1.82, p = 0.019). Chemotherapy produced a substantial reduction in risk of death (HR 0.72 CI 0.421-1.235, p = 0.23). Conclusions: In this prospective but nonrandomized study of treatment for first LRR, the risk of death in the later control cohort was 1.39 times the risk in the chemotherapy cohort but failed to reach statistical significance. The results justify further study

  2. The treatment of advanced stage favorable histology non-Hodgkin's lymphoma: a preliminary report of a randomized trial comparing single agent chemotherapy, combination chemotherapy, and whole body irradiation

    International Nuclear Information System (INIS)

    Between 1975 and 1978, 51 patients with favorable histology non-Hodgkin's lymphomas, pathologic stage III-IV, were treated prospectively on a randomized treatment protocol. Treatment options were single alkylating agent chemotherapy, combination chemotherapy with cyclophosphamide, vincristine, and prednisone (CVP), or fractionated whole body irradiation followed by low dose involved field irradiation. The median follow-up interval in this group of patients is not 41 mo. Actuarial survival is excellent, 84% at 4 yr for the entire group, with similar survival observed for each of the three treatment options. Initial complete remission rates (64%, 88%, and 71%) were not significantly different in the three treatment arms. Frequent relapse after initial remission induction was noted, however, with a freedom from relapse at 4 yr of only 25%. The toxicities of the three therapies were acceptable. Acute complications of therapy were most numerous in the group of patients treated with CVP; however, long-term hematologic depression was most commonly observed in patients treated with whole body irradiation. In general, hematologic complications were more frequent among patients who had marrow involvement and intact spleens at the time of initial therapy. The relationship of this study to other clinical trials in the management of patients with advanced stage favorable histology lymphomas and its implications for future clinical trials are discussed

  3. A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy-Induced Hematological Complications in Breast Cancer

    OpenAIRE

    Yaal-Hahoshen, Neora; Maimon, Yair; Siegelmann-Danieli, Nava; Lev-Ari, Shahar; Ron, Ilan G.; Sperber, Fani; Samuels, Noah; Shoham, Jacob; MERIMSKY, OFER

    2011-01-01

    The safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 were evaluated in the prevention of chemotherapy-induced hematological toxicity in breast cancer patients in a prospective, controlled study.

  4. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study

    International Nuclear Information System (INIS)

    In Europe, gastric cancer remains diagnosed at advanced stage (serosal and/or lymph node involvement). Despite curative management combining perioperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection, 5-year survival rates of T3 and/or N + patients remain under 30%. More than 50% of recurrences are peritoneal and/or locoregional. The use of adjuvant hyperthermic intraperitoneal chemotherapy that eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences, was extensively evaluated by several randomized trials conducted in Asia. Two meta-analysis reported that adjuvant hyperthermic intraperitoneal chemotherapy significantly reduces the peritoneal recurrences and significantly improves the overall survival. As it was previously done for the evaluation of the extension of lymph node dissection, it seems very important to validate on European or caucasian patients the results observed in trials performed in Asia. GASTRICHIP is a prospective, open, randomized multicenter phase III clinical study with two arms that aims to evaluate the effects of hyperthermic intraperitoneal chemotherapy with oxaliplatin on patients with gastric cancer involving the serosa and/or lymph node involvement and/or with positive cytology at peritoneal washing, treated with perioperative systemic chemotherapy and D1-D2 curative gastrectomy. Peroperatively, at the end of curative surgery, patients will be randomized after preoperatively written consent has been given for participation. Primary endpoint will be overall survival from the date of surgery to the date of death or to the end of follow-up (5 years). Secondary endpoint will be 3- and 5-year recurrence-free survival, site of recurrence, morbidity, and quality of life. An ancillary study will compare the incidence of positive peritoneal cytology pre- and post-gastrectomy in two arms of the study, and assess its impact on 5-year

  5. Chemotherapy

    Science.gov (United States)

    ... whose cancer is being treated with chemotherapy, your doctors, nurses, and other members of the cancer treatment team ... takes to follow their dreams. Talk with your doctors, nurses, family, and friends if you have any questions ...

  6. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P;

    2000-01-01

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD......) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... in the study.Twenty-five patients completed the study. INTERVENTIONS: After randomization, 17 patients were allocated to APD treatment and 17 patients to CAPD treatment for a period of 6 months. Medical and biochemical parameters were evaluated at monthly controls in the CAPD units. Quality-of-life parameters...

  7. Intravenous chemotherapy for resected gastric cancer: meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Jian-Kun Hu; You-Ping Li; Zhi-Xin Chen; Zong-Guang Zhou; Bo Zhang; Jing Tian; Jia-Ping Chen; Li Wang; Chao-Hua Wang; Hong-Yan Chen

    2002-01-01

    AIM: To assess the safety and efficacy of different intravenous chemotherapeutic regimens in patients with gastric carcinomas who had undergone gastrectomy.METHODS: A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. Language was restricted to Chinese and English. RCTs were identified from Medline and Embase (1980-2001/4), and Chinese Biowere checked at the same time. We included randomized and quasi-randomized trials comparing the efficacy of intravenous chemotherapy after gastrectomy with that of surgery alone in patients with confirmed gastric carcinomas who had undergone gastrectomy. Selection criteria were: randomized or quasi-randomized trials with following-up results; Trials could be double-blind, single-blind or not blind; Chemotherapy groups were given intravenous chemotherapy after gastrectomy without neo-adjuvant chemotherapy, intraperitoneal hyperthermic perfusion, radiotherapy or chemoimmunotherapy; Controlled group included those receiving gastrectomy alone. The following data were extracted: the number of survival and death by the end of the follow-up; the different agents and doses of the intravenous chemotherapy; the baseline of the chemotherapy group and the controlled arm; the serious adverse events; the statistical consideration; cost-effectiveness analysis. The statistical analysis was performed by RevMan4.1 software which was provided by the Cochrane Collaboration. A Pvalue of <0.05 was considered statistically significant. Metaanalysis was done with random effects model. Heterogeneity was checked by chi-square test. Sensitivity analysis was performed by excluding the trials in which Jadad-scale was only 1 score. The result was expressed with odds ratio (OR) for the categorical variable.RESULTS: Fourteen trials involving 4543 patients were included. Meta-analysis was done with random effects model. Heterogeneity and sensitivity analysis were performed also. The effect of intravenous chemotherapy after

  8. ADJUVANT CHEMOTHERAPY FOLLOWING RADICAL SURGERY FOR NON-SMALL CELL LUNG CANCER:A RANDOMIZED STUDY

    Institute of Scientific and Technical Information of China (English)

    XU Guang-chuan; RONG Tie-hua; LIN Peng

    1999-01-01

    Objective: To evaluate the efficacy of adjuvant chemotherapy after radical surgery for non-small cell lung cancer (NSCLC). Methods: Seventy patients with NSCLC (stage Ⅰ-Ⅲ) undergone radical surgery were randomized into two groups: 35 patients received adjuvant chemotherapy with cyclophosphamide (CTX)300 mg/m2, vincristine (VCR) 1.4% mg/m2, adriamycin (ADM) 50 mg/m2, lomustine (CCNU) 50 mg/m2 d1,cisplatin (DDP) 20 mg/m2, d1-5, for 4 cycles, and followed by oral Ftorafur (FT-207) 600-900 mg/d for 1year (adjuvant chemotherapy group). The other 35patients received surgical treatment only (surgery group). Results: The overall 5-year survival rate was 48.6% in the adjuvant chemotherapy group, and 31.4%in the surgery group, respectively. The difference between the two groups was not statistically significant (P>0.05). The 5-year survival rate of patients in stage Ⅲwas 44.0% and 20.8% received surgery with and without adjuvant chemotherapy, respectively. The difference between the two groups was statistically significant (P<0.025). The 5-year survival rate of patients in stage Ⅰ-Ⅱ in the two groups was 60.0% and 54.5%, respectively (P>0.75). Conclusion: Postoperative adjuvant chemotherapy in NSCLC can improve survival, for those patients in stage Ⅲ, it suggests significantly 5-year survival rate in the adjuvant chemotherapy group was higher than that in the surgery alone group.

  9. Optimizing treatment strategies in myeloma cast nephropathy: rationale for a randomized prospective trial.

    Science.gov (United States)

    Bridoux, Frank; Fermand, Jean-Paul

    2012-09-01

    Renal failure is a frequent complication of multiple myeloma (MM) that strongly affects patient survival. Although a variety of renal diseases may be observed in MM, myeloma cast nephropathy (MCN), a tubulo-interstitial disorder related to precipitation of a monoclonal light chain (LC) within tubular distal lumens, is the main cause of severe and persistent renal failure. To date, the respective frequency and initial evolution of renal disorders associated with monoclonal LC in MM remain poorly defined. Treatment of MCN relies on urgent symptomatic measures and rapid introduction of chemotherapy to reduce the production of monoclonal LC. The introduction of novel chemotherapy regimens based on the association of bortezomib with dexamethasone is likely to have improved the prognosis of MM patients with renal failure. In addition, the combination of novel agents with efficient removal of circulating LC through high cut-off hemodialysis membrane may further increase renal response rate. However, the impact on patient and renal outcomes of these potential therapeutic advances has not been evaluated in prospective studies. The randomized trials EuLITE in the UK and Germany and MYRE in France should help to answer these issues. MYRE is a randomized controlled phase III trial (NCT01208818) that aims to better define the epidemiology and typology of inaugural renal failure in MM and to optimize therapy of MCN patients with and without dialysis-dependent renal failure. PMID:22920644

  10. Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial

    Directory of Open Access Journals (Sweden)

    Wilfried Tröger

    2014-01-01

    Full Text Available Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy. Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n = 34 versus untreated control (n = 31. Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P<0.001 to P=0.038 in Dunnett-T3 test. The difference was clinically relevant (difference of at least 5 points, range 5.4–12.2 in eight of the ten scores. Neutropenia occurred in 7/34 HxA patients and in 8/31 control patients (P = 0.628. Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here.

  11. Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial.

    Science.gov (United States)

    Tröger, Wilfried; Zdrale, Zdravko; Tišma, Nevena; Matijašević, Miodrag

    2014-01-01

    Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy. Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n = 34) versus untreated control (n = 31). Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P control patients (P = 0.628). Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here. PMID:24701238

  12. Effect of Chewing Gum on Oral Mucositis in Children Undergoing Chemotherapy: A Randomized Controlled Study

    Science.gov (United States)

    Eghbali, A; Taherkhanchi, B; Bagheri, B; Sadeghi Sedeh, B

    2016-01-01

    Background Oral mucositis is an adverse effect of chemotherapy. Type of chemotherapy regimen is the most important factor causing mucositis. Oral mucositis is usually associated with transient decrease in saliva production. The goal was to study effects of gum consumption on oral mucositis in children undergoing chemotherapy. Materials and Method This randomized controlled trial was done in Amir Kabir Hospital, Arak, Iran. 130 children 5 to 15 years of age were studied. Control group was composed of 65 children who received mucotoxic drugs. Test group was made up of 65 patients received similar drugs in addition to sugar free gums. Patients consumed 6 pieces of gums per day for 15 days. A standardized follow up form and World Health Organization (WHO) grading system for oral mucositis were used for evaluation of patients during 15 days of treatment. Results Severe oral mucositis occurred in 30 (46%) of 65 patients in the test group and in 26 of 65 (40%) patients in the control group. Difference was not statistically significant (P > 0.05). Rate of mild to moderate mucoitis (grade 1 and 2) was significantly lower in patients who used gums (15 % vs. 35%, P < 0.05). Conclusion Our study showed that stimulation of saliva flow by chewing gum could decrease mild to moderate inflammatory injuries of the oral mucosa during chemotherapy. However, it was not effective to subside severe mucositis.

  13. Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study

    International Nuclear Information System (INIS)

    Recombinant human endostatin (rh-endostatin) is a novel antiangiogenesis drug developed in China. Previous experiments have shown that rh-endostatin can inhibit the proliferation and migration of endothelial cells and some types of tumor cells. In this study, we evaluated the efficacy and safety profiles of combination therapy of rh-endostatin and neoadjuvant chemotherapy for breast cancer patients in a prospective, randomized, controlled, phase II trial. Sixty-eight patients with core-biopsy confirmed breast cancer were allocated randomly to two groups to receive 3 cycles of intravenous administration of either neoadjuvant DE (docetaxel: 75 mg/m2, d1, epirubicin: 75 mg/m2, d1, every 3 weeks), or neoadjuvant DE combined with rh-endostatin (7.5 mg/m2, d1-d14, every 3 weeks). The primary end point was clinical response based upon Response Evaluation Criteria in Solid Tumors, and the secondary end point was safety and quality of life. All patients were assessable for toxicity and 64 (94.2%) were assessable for efficacy evaluation. The objective response rate was 67.7% for chemotherapy (n = 31) and 90.9% for rh-endostatin plus chemotherapy (n = 33) (P = 0.021). A retrospective subset analysis revealed that rh-endostatin was more effective in premenopausal patients and patients with ECOG score of zero (P = 0.002 and P = 0.049, respectively). Five patients in the rh-endostatin plus chemotherapy arm achieved pathologic complete response compared with 2 in the chemotherapy arm (P = 0.428). No significant difference was identified in quality of life score and side effects (P > 0.05). The combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients. ClinicalTrials.gov Identifier, http://www.clinicaltrials.gov/ct2/show/NCT00604435?term

  14. Post chemotherapy blood and bone marrow regenerative changes in childhood acute lymphoblastic leukemia a prospective study

    Directory of Open Access Journals (Sweden)

    Rashmi Kushwaha

    2014-01-01

    Full Text Available Context: This study was done to assess the Serial peripheral blood and bone marrow changes in patients of Acute Lymphoblastic Leukemia on chemotherapy. Aims: To assess the therapy related serial bone marrow changes in patients of Acute Lymphoblastic Leukemia. Settings and Design: Prospective study, carried out in Lymphoma- Leukemia Lab, Department of Pathology, K.G.M.U from March 2011 to March 2012. A total of 60 cases were studied Materials and Methods: History, complete hemogram, bone marrow examination at pretherapy (Day-0, intratherapy (Day-14, and end of induction chemotherapy (Day-28 were done. Peripheral blood smears were evaluated at regular interval to assess clearance of blast cells. Statistical analysis used: The statistical analysis was done using SPSS (Statistical Package for Social Sciences Version 15.0 statistical Analysis Software. The values were represented in Number (% and Mean ± SD. The following Statistical formulas were used: Mean, standard deviation, Chi square test, Paired "t" test, Student ′t′ test, Level of significance P Results: Incidence of ALL-L1 (46.7% and ALL-L2 (53.3% was equal. ALL-L2 patients had poor survival.Day 0 (D-0 bone marrow was hypercellular with flooding of marrow by leukemic cells. High levels of tumor load at D′0′ were associated with poor survival. 14 th day of Induction phase showed significant decrease in hemoglobin and TLC as compared to D ′0′ parameters. D28 showed marrow regeneration. Cellularity, Blast%, and Leukemic Index showed significant drop from day ′0′ to day 14 due to myelosupression, whereas regeneration reflected by increased cellularity as per day 28 marrow. Lymphocytosis (>20% at end of induction chemotherapy had better survival and longer remission.Risk of mortality was directly proportional to blast clearance and was a major independent prognostic factor for achievement of complete remission. Conclusions: A bone marrow examination at the end of induction

  15. Glutamine supplementation in cancer patients receiving chemotherapy: a double-blind randomized study.

    Science.gov (United States)

    Bozzetti, F; Biganzoli, L; Gavazzi, C; Cappuzzo, F; Carnaghi, C; Buzzoni, R; Dibartolomeo, M; Baietta, E

    1997-01-01

    The purpose of this study was to evaluate the efficacy of glutamine in preventing doxifluridine-induced diarrhea and the potential impact of glutamine on the tumor growth. We investigated 65 patients with advanced breast cancer receiving doxifluridine in a double-blind randomized fashion: 33 patients took glutamine (30 g/d, divided in 3 doses of 10 g each) for 8 consecutive days (5-12h) during each interval between chemotherapy, which was administered from day 1 to 4. Thirty-two patients took an equal dose of placebo (maltodextrine). The incidence of diarrhea was registered after each cycle of chemotherapy and severity was scored by the National Cancer Institute (NCI), Bethesda, Maryland, classification. The tumor response was evaluated by the World Health Organization (WHO) criteria. A total of 278 and 259 cycles (median 10 cycles), respectively, were delivered in glutamine and placebo groups. There were 34 and 32 episodes of diarrhea in glutamine and placebo groups, with no statistical difference overall, in the severity and duration of tumor growth, there was no difference in the response rate (21% and 28% of complete or partial response, respectively), in median time to response (2 mo), or in median duration of response. In conclusion, glutamine did not prevent the occurrence of the doxifluridine-induced diarrhea and did not have any impact on tumor response to chemotherapy. PMID:9263281

  16. Hypofractionated Dose-Painting Intensity Modulated Radiation Therapy with Chemotherapy for Nasopharyngeal Carcinoma, a Prospective Trial

    Science.gov (United States)

    Bakst, Richard L.; Lee, Nancy; Pfister, David G.; Zelefsky, Michael J.; Hunt, Margie A.; Kraus, Dennis H.; Wolden, Suzanne L.

    2010-01-01

    Purpose To evaluate the feasibility of Dose-Painting Intensity-Modulated Radiation Therapy (DP-IMRT) with a hypofractionated regimen to treat nasopharyngeal carcinoma (NPC) with concomitant toxicity reduction. Materials/Methods From 10/02–4/07, 25 newly diagnosed NPC patients were enrolled on a prospective trial. DP-IMRT was prescribed to deliver 70.2 Gy using 2.34 Gy fractions to the gross tumor volume for the primary and nodal sites while simultaneously delivering 54 Gy in 1.8 Gy fractions to regions at risk of microscopic disease. Patients received concurrent and adjuvant platin–based chemotherapy similar to the Intergroup 0099 trial. Results Patient/disease characteristics: median age 46; 44% Asian; 68% male; 76% WHO III; 20% T1, 52% T2, 16% T3, 12% T4; 20% N0, 36% N1, 36% N2, 8% N3. With median follow-up of 33 months, 3-year local control was 91%, regional control was 91%, freedom from distant metastases was 91%, and overall survival was 89%. The average mean dose to each cochlea was 43 Gy. With median audiogram follow-up of 14 months, only one patient had clinically significant (grade 3) hearing loss. 12% of patients developed temporal lobe necrosis; one patient required surgical resection. Conclusions Preliminary findings using a hypofractionated DP-IMRT regimen demonstrated that local control, freedom from distant metastases and overall survival compared favorably to other series of IMRT and chemotherapy. The highly conformal boost to the tumor bed resulted low rates of severe ototoxicity (Grade 3–4). However, the incidence of in-field brain radiation necrosis indicates that 2.34 Gy per fraction is not safe in this setting. PMID:20605352

  17. Quality of life after cytoreductive surgery plus early intraperitoneal postoperative chemotherapy for pseudomyxoma peritonei: A prospective study

    DEFF Research Database (Denmark)

    Jess, Per; Iversen, Lene Hjerrild; Nielsen, Mette B;

    2008-01-01

    PURPOSE: The modern treatment of pseudomyxoma peritonei is cytoreductive surgery plus intraperitoneal chemotherapy resulting in a survival of up to 70 percent after 20 years. The goal of this study was to investigate the impact on quality of life of this very aggressive treatment, which has not...... been done before. METHODS: Twenty-three prospective patients underwent cytoreductive surgery and early postoperative intraperitoneal chemotherapy for pseudomyxoma peritonei. Patients were followed in clinic 3, 6, 12, 18, and 24 months after surgery and had CT scan of the abdomen every 6 months. Quality...... returning to normal after another three months. The other scores corresponded to the scores in a normal population. CONCLUSIONS: Cytoreductive surgery plus early postoperative intraperitoneal chemotherapy is an extensive treatment with a high morbidity but with relatively little impact on quality of life in...

  18. Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone

    Directory of Open Access Journals (Sweden)

    Wilfried Tröger

    2009-01-01

    Full Text Available Background: Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia.Patients and Methods: We conducted a prospective randomized open label pilot study with 95 patients randomized into three groups. Two groups received Iscador® M special (IMS or a different mistletoe preparation, respectively, additionally to chemotherapy with six cycles of cyclophosphamide, adriamycin, and 5-fluoro-uracil (CAF. A control group received CAF with no additional therapy. Here we report the comparison IMS (n = 30 vs. control (n = 31. Quality of life including fatigue was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30. Neutropenia was defined as neutrophil counts <1,000/µl and assessed at baseline and one day before each CAF cycle.Results: In the descriptive analysis all 15 scores of the EORTC-QLQ-C30 showed better quality of life in the IMS group compared to the control group. In 12 scores the differences were significant (p < 0.02 and nine scores showed a clinically relevant and significant difference of at least 5 points. Neutropenia occurred in 3/30 IMS patients and in 8/31 control patients (p = 0.182.Conclusions: This pilot study showed an improvement of quality of life by treating breast cancer patients with IMS additionally to CAF. CAF-induced neutropenia showed a trend to lower frequency in the IMS group.

  19. Randomized in vivo evaluation of photodynamic antimicrobial chemotherapy on deciduous carious dentin

    Science.gov (United States)

    Steiner-Oliveira, Carolina; Longo, Priscila Larcher; Aranha, Ana Cecília Corrêa; Ramalho, Karen Müller; Mayer, Marcia Pinto Alves; de Paula Eduardo, Carlos

    2015-10-01

    The aim of this randomized in vivo study was to compare antimicrobial chemotherapies in primary carious dentin. Thirty-two participants ages 5 to 7 years underwent partial caries removal from deep carious dentin lesions in primary molars and were subsequently divided into three groups: control [chlorhexidine and resin-modified glass ionomer cement (RMGIC)], LEDTB [photodynamic antimicrobial chemotherapy (PACT) with light-emitting diode associated with toluidine blue solution and RMGIC], and LMB [PACT with laser associated with methylene blue solution and RMGIC]. The participants were submitted to initial clinical and radiographic examinations. Demographic features and biofilm, gingival, and DMFT/DMFS indexes were evaluated, in addition to clinical and radiographic followups at 6 and 12 months after treatments. Carious dentin was collected before and after each treatment, and the number of Streptococcus mutans, Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae, and total bacteria was established by quantitative polymerase chain reaction. No signs of pain or restoration failure were observed. All therapies were effective in reducing the number of microorganisms, except for S. sobrinus. No statistical differences were observed among the protocols used. All therapies may be considered as effective modern approaches to minimal intervention for the management of deep primary caries treatment.

  20. Patients’ perspectives on palliative chemotherapy of colorectal and non - colorectal cancer: a prospective study in a chemotherapy- experienced population

    International Nuclear Information System (INIS)

    A better understanding of patients’ views on the benefit and burden obtained from palliative chemotherapy would facilitate shared decision making. We evaluated palliative cancer patients’ reported outcomes (PROs) for toxicity and investigated the survival threshold for which they would repeat chemotherapy (CTx). Patients who had received a minimum of three months of palliative CTx for advanced colorectal (CRC) or non-colorectal (non-CRC: upper gastrointestinal, lung and head-and-neck) cancer were assessed by questionnaire. Patients were questioned about PROs for toxicity, subjective burden from side effects, and were asked for the survival threshold necessary for them to repeat CTx. Expected survival (sum of indicated survival threshold and median survival time with best supportive care) was compared to the patients’ actual survival. One hundred and thirty-four patients (CRC: 58; non-CRC: 76) were surveyed. The most frequent PRO- grade 3/4 toxicities were acne (12.8%), fatigue (9.0%), and diarrhea (8.5%). The symptom causing the highest subjective burden was fatigue and was worse than expected in 29.9% of the patients. The median survival threshold for which patients would repeat CTx was significantly longer in CRC than in non-CRC patients (p=0.01). Median expected survival was significantly longer than actual median survival (CRC: 44.0 months [22.0-65.9] compared with 30.0 months of actual survival [20.9-39.1]; non-CRC: 22.0 months [15.3-28.6] compared with 19.0 months of actual survival [15.1-22.9], p=0.03). Fatigue deserves more attention when toxicity of treatment and symptoms of disease are explained to patients. Patients’ survival expectations from palliative chemotherapy are higher than previously described, exceed the median survival time known from phase III trials, and are significantly longer than their actual survival

  1. Impact of Chemotherapy on Diet and Nutritional Status of Women with Breast Cancer: A Prospective Study.

    Directory of Open Access Journals (Sweden)

    Isis Danyelle Dias Custódio

    Full Text Available Certain food groups are often rejected during chemotherapy (CT due to the side effects of treatment, which may interfere with adequate diet and nutritional status. The aim of this study was to evaluate the treatment impact on the diet and nutritional status of women with breast cancer (BC. In this prospective longitudinal study, conducted in 2014-2015, 55 women diagnosed with BC, with a mean age 51.5±10.1 years, were followed and data were collected at three different times. Anthropometric and dietary assessments were performed, the latter by applying nine 24h dietary recalls, by using the Brazilian Healthy Eating Index Revised (BHEI-R, and calculating the prevalence of inadequacy by the EAR cut-off point method. Regarding the BHEI-R analysis, the majority of women had a "diet requires modification', both at the beginning (T0, 58.2%, n = 32 and during treatment (T1, 54.5%, n = 30. However, after the end of the CT, the greater percentage of patients (T2, 49.1%, n = 27 were classified as having an "inadequate diet", since the Total Fruit consumption as well as the Dark Green and Orange Vegetable and Legume consumption decreased significantly during treatment (p = 0.043 and p = 0.026, respectively. There was a significant reduction in the intake of macro and micronutrients, with a high prevalence of inadequacy, of up to 100%, for calcium, iron, phosphorus, magnesium, niacin, riboflavin, thiamin, vitamin B6, vitamin C and zinc. Assessment of the nutritional status indicated that 56% (n = 31 of patients were overweight at these three different times. Weight, BMI and Waist Circumference increased significantly, indicating a worse nutritional status, and there was a correlation between poor diet quality and higher values for BMI, Waist-Hip Ratio and Waist-to-Height Ratio. Chemotherapy interferes in the patients' diet generating a negative impact on the quality and intake of micro and macronutrients, as well as an impact on their nutritional status

  2. Impact of Chemotherapy on Diet and Nutritional Status of Women with Breast Cancer: A Prospective Study

    Science.gov (United States)

    Gontijo, Cristiana Araújo; Pereira, Taísa Sabrina Silva; Paiva, Carlos Eduardo

    2016-01-01

    Certain food groups are often rejected during chemotherapy (CT) due to the side effects of treatment, which may interfere with adequate diet and nutritional status. The aim of this study was to evaluate the treatment impact on the diet and nutritional status of women with breast cancer (BC). In this prospective longitudinal study, conducted in 2014–2015, 55 women diagnosed with BC, with a mean age 51.5±10.1 years, were followed and data were collected at three different times. Anthropometric and dietary assessments were performed, the latter by applying nine 24h dietary recalls, by using the Brazilian Healthy Eating Index Revised (BHEI-R), and calculating the prevalence of inadequacy by the EAR cut-off point method. Regarding the BHEI-R analysis, the majority of women had a “diet requires modification’, both at the beginning (T0, 58.2%, n = 32) and during treatment (T1, 54.5%, n = 30). However, after the end of the CT, the greater percentage of patients (T2, 49.1%, n = 27) were classified as having an "inadequate diet", since the Total Fruit consumption as well as the Dark Green and Orange Vegetable and Legume consumption decreased significantly during treatment (p = 0.043 and p = 0.026, respectively). There was a significant reduction in the intake of macro and micronutrients, with a high prevalence of inadequacy, of up to 100%, for calcium, iron, phosphorus, magnesium, niacin, riboflavin, thiamin, vitamin B6, vitamin C and zinc. Assessment of the nutritional status indicated that 56% (n = 31) of patients were overweight at these three different times. Weight, BMI and Waist Circumference increased significantly, indicating a worse nutritional status, and there was a correlation between poor diet quality and higher values for BMI, Waist-Hip Ratio and Waist-to-Height Ratio. Chemotherapy interferes in the patients’ diet generating a negative impact on the quality and intake of micro and macronutrients, as well as an impact on their nutritional status, with

  3. Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LYO2)

    International Nuclear Information System (INIS)

    Full text: A quality assurance (QA) audit of the Trans Tasman Radiation Oncology Group and Australasian Lymphoma and Leukaemia Group trial (TROG 99.04/ALLG LY02) began after accrual of 25 patients. The trial is a prospective non-randomized study of standard treatment for osteolymphoma. Data relating to informed consent, eligibility, chemotherapy and radiotherapy were reviewed. The audit showed a relatively low level of major variations from the protocol, with an overall rate of 3.6%. As this trial has accrued slowly over a long period, the concept of QA has also developed. Amendments were made to the protocol accordingly. In the future, QA procedures should be predetermined, conducted rapidly in real time, and appropriately funded in order to be relevant to the ongoing conduct of the trial.

  4. Randomized prospective evaluation of nephrostomy tube configuration: impact on postoperative pain

    OpenAIRE

    Derek Weiland; Pedro, Renato N.; Kyle Anderson, J.; Best, Sara L.; Lee Courtney; Kari Hendlin; Johnstone Kim; Manoj Monga

    2007-01-01

    OBJECTIVE: Conduct a prospective randomized single-blind comparison of two nephrostomy catheter designs, evaluating specifically intraoperative placement and postoperative comfort. MATERIALS AND METHODS: The single-blind, prospective randomized trial was conducted with institutional review board approval. All patients undergoing percutaneous nephrolithotomy who gave informed consent were randomized to placement of either a Boston Scientific Flexima 8.3F pigtail nephrostomy tube #27-180 (PIG) ...

  5. Letter to the Editor Regarding “A Prospective, Controlled Study of the Botanical Compound Mixture LCS101 for Chemotherapy-Induced Hematological Complications in Breast Cancer” by Yaal-Hahoshen et al. (The Oncologist 2011;16:1197–1202)

    OpenAIRE

    Mooiman, Kim D.; Goey, Andrew K.L.; Meijerman, Irma; Beijnen, Jos H.; Schellens, Jan H. M.

    2012-01-01

    A prospective, randomized, placebo-controlled study by Yaal-Hahoshen et al. published in a recent issue of The Oncologist that concluded that the botanical mixture LCS101 prevented hematological complications in breast cancer patients undergoing anthracycline- and taxane-based chemotherapy is critically reviewed.

  6. Impact of Postoperative Radiation Therapy on Survival in Patients With Complete Resection and Stage I, II, or IIIA Non-Small-Cell Lung Cancer Treated With Adjuvant Chemotherapy: The Adjuvant Navelbine International Trialist Association (ANITA) Randomized Trial

    International Nuclear Information System (INIS)

    Purpose: To study the impact of postoperative radiation therapy (PORT) on survival in the Adjuvant Navelbine International Trialist Association (ANITA) randomized study of adjuvant chemotherapy. Methods and Materials: ANITA is a randomized trial of adjuvant cisplatin and vinorelbine chemotherapy vs. observation in completely resected non-small-cell lung carcinoma (NSCLC) Stages IB to IIIA. Use of PORT was recommended for pN+ disease but was not randomized or mandatory. Each center decided whether to use PORT before initiation of the study. We describe here the survival of patients with and without PORT within each treatment group of ANITA. No statistical comparison of survival was performed because this was an unplanned subgroup analysis. Results: Overall, 232 of 840 patients received PORT (33.3% in the observation arm and 21.6% in the chemotherapy arm). In univariate analysis, PORT had a deleterious effect on the overall population survival. Patients with pN1 disease had an improved survival from PORT in the observation arm (median survival [MS] 25.9 vs. 50.2 months), whereas PORT had a detrimental effect in the chemotherapy group (MS 93.6 months and 46.6 months). In contrast, survival was improved in patients with pN2 disease who received PORT, both in the chemotherapy (MS 23.8 vs. 47.4 months) and observation arm (median 12.7 vs. 22.7 months). Conclusion: This retrospective evaluation suggests a positive effect of PORT in pN2 disease and a negative effect on pN1 disease when patients received adjuvant chemotherapy. The results support further evaluation of PORT in prospectively randomized studies in completely resected pN2 NSCLC

  7. Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small-cell lung cancer: a multicenter, randomized, open-label Phase II study

    Directory of Open Access Journals (Sweden)

    Babu KG

    2014-06-01

    Full Text Available K Govind Babu,1 Kumar Prabhash,2 Ashok K Vaid,3 Bhawna Sirohi,3 Ravi B Diwakar,4 Raghunadha Rao,5 Madhuchanda Kar,6 Hemant Malhotra,7 Shona Nag,8 Chanchal Goswami,9 Vinod Raina,10 Ravi Mohan111Kidwai Memorial Institute of Oncology, Bangalore, 2Tata Memorial Hospital, Mumbai, 3Artemis Health Institute, Delhi, 4Bangalore Institute of Oncology, Bangalore, 5Nizam Institute of Medical Sciences, Hyderabad, 6B R Singh Hospital, Kolkata, 7Birla Cancer Centre, Jaipur, 8Jehangir Hospital, Pune, 9B P Poddar Hospital and Medical Research Ltd, Kolkata, 10Institute Rotary Cancer Hospital, New Delhi, 11King George Hospital, Visakhapatnam, IndiaBackground: The purpose of this study was to evaluate the safety and efficacy of nimotuzumab in combination with chemotherapy (docetaxel and carboplatin versus chemotherapy alone in patients with stage IIIB/IV non-small-cell lung cancer.Methods: This multicenter, open-label, Phase II study randomized 110 patients to receive nimotuzumab plus chemotherapy (nimotuzumab group or chemotherapy alone (control group, and comprised concomitant, maintenance, and follow-up phases. Nimotuzumab 200 mg was administered once weekly for 13 weeks during the first two phases with four cycles of chemotherapy and docetaxel 75 mg/m2 and carboplatin (area under the curve 5 mg/mL*min every 3 weeks for a maximum of four cycles during the concomitant phase. The primary endpoint was objective response rate (sum of complete response and partial response. Secondary endpoints, ie, overall survival and progression-free survival, were estimated using the Kaplan–Meier method. Efficacy was evaluated on the intent-to-treat and efficacy-evaluable sets. Safety was assessed from adverse event and serious adverse event data.Results: The objective response rate was significantly higher in the nimotuzumab group than in the control group in the intent-to-treat population (54% versus 34.5%; P=0.04. A complete response and partial response were achieved in 3

  8. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  9. [Evaluation of the complementary drug Factor AF2 as a supportive agent in management of advanced urothelial carcinoma. Prospective randomized multicenter study].

    Science.gov (United States)

    Krege, S; Hinke, A; Otto, T; Rübben, H

    2002-03-01

    This is a prospective randomized multicenter trial for evaluation of the biological response modifier Factor AF2 in advanced urothelial cancer treated with chemotherapy. Main aim of the study was the analysis of supportive effects. Additionally patients were examined with regard to tumor response, time to progression and survival. 106 patients with advanced urothelial cancer received chemotherapy with cisplatin and methotrexate. They were randomized for additional Factor AF2 (500 mg i.v., given at days 0-3, 7-10 and 11-14). Myelotoxicity was more common and severe in the group without Factor AF2 reaching statistical significance. Gastrointestinal side effects occurred in both groups, though grade III to IV toxicity was more common without Factor AF2. Overall remission rate was 38%, median survival 33 weeks, mean time to progression 20 weeks. There was no significant difference between the two groups with or without Factor AF2. PMID:11993095

  10. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy

    DEFF Research Database (Denmark)

    De Santis, Maria; Bellmunt, Joaquim; Mead, Graham;

    2012-01-01

    This is the first randomized phase II/III trial comparing two carboplatin-based chemotherapy regimens in patients with urothelial cancer who are ineligible ("unfit") for cisplatin chemotherapy.......This is the first randomized phase II/III trial comparing two carboplatin-based chemotherapy regimens in patients with urothelial cancer who are ineligible ("unfit") for cisplatin chemotherapy....

  11. A randomized trial of amifostine in patients with high-dose VIC chemotherapy plus autologous blood stem cell transplanation

    OpenAIRE

    Hartmann, J T; Vangerow, A von; Fels, L M; Knop, S.; Stolte, H.; Kanz, L; Bokemeyer, C

    2001-01-01

    This pilot study evaluates the degree of side effects during high-dose chemotherapy (HD-VIC) plus autologous bone marrow transplant (HDCT) and its possible prevention by the cytoprotective thiol-derivate amifostine. Additionally, the in-patient medical costs of both treatment arms were compared. 40 patients with solid tumours were randomized to receive HD-VIC chemotherapy with or without amifostine (910 mg/m2 at day 1–3) given as a short infusion prior to carboplatin and ifosfamide. Patients ...

  12. Fractionated stereotactic radiosurgery with concurrent temozolomide chemotherapy for locally recurrent glioblastoma multiforme: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Greenspoon JN

    2014-03-01

    Full Text Available Jeffrey Noah Greenspoon,1 Waseem Sharieff,1 Holger Hirte,1 Andrew Overholt,1 Rocco Devillers,2 Thorsteinn Gunnarsson,2 Anthony Whitton11Department of Oncology, McMaster University, ON, Canada; 2Department of Surgery, McMaster University, ON, CanadaAbstract: Local recurrence represents a significant challenge in the management of patients with glioblastoma multiforme. Salvage treatment options are limited by lack of clinical efficacy. Recent studies have demonstrated a significant response rate and acceptable toxicity with the use of fractionated stereotactic radiosurgery in this patient population. Our primary objective was to determine the efficacy and toxicity of fractionated stereotactic radiosurgery combined with concurrent temozolomide chemotherapy as a salvage treatment for recurrent glioblastoma multiforme. We prospectively collected treatment and outcome data for patients having fractionated stereotactic radiosurgery for locally recurrent glioblastoma multiforme after radical radiotherapy. Eligible patients had a maximum recurrence diameter of 60 mm without causing significant mass effect. The gross tumor volume was defined as the enhancing lesion on an enhanced fine-slice T1 (spin–lattice magnetic resonance imaging, and a circumferential setup margin of 1 mm was used to define the planning target volume. All patients were treated using robotic radiosurgery with three dose/fractionation schedules ranging from 25 to 35 Gy in five fractions, depending on the maximum tumor diameter. Concurrent temozolomide 75 mg/m2 was prescribed to all patients. Tumor response was judged using the Macdonald criteria, and toxicity was assessed using the CTCAE (Common Terminology Criteria for Adverse Events. A total of 31 patients were enrolled in this study. The median overall survival was 9 months, and progression-free survival was 7 months. The 6-month progression-free survival was 60% with a 95% confidence interval of 43%–77%. The a priori

  13. A Prospective Randomized Study of the Radiotherapy Volume for Limited-stage Small Cell Lung Cancer: A Preliminary Report

    Directory of Open Access Journals (Sweden)

    Xiao HU

    2010-07-01

    Full Text Available Background and objective Controversies exists with regard to target volumes as far as thoracic radiotherapy (TRT is concerned in the multimodality treatment for limited-stage small cell lung cancer (LSCLC. The aim of this study is to prospectively compare the local control rate, toxicity profiles, and overall survival (OS between patients received different target volumes irradiation after induction chemotherapy. Methods LSCLC patients received 2 cycles of etoposide and cisplatin (EP induction chemotherapy and were randomly assigned to receive TRT to either the post- or pre-chemotherapy tumor extent (GTV-T as study arm and control arm, CTV-N included the positive nodal drainage area for both arms. One to 2 weeks after induction chemotherapy, 45 Gy/30 Fx/19 d TRT was administered concurrently with the third cycle of EP regimen. After that, additional 3 cycles of EP consolidation were administered. Prophylactic cranial irradiation (PCI was administered to patients with a complete response. Results Thirty-seven and 40 patients were randomly assigned to study arm and control arm. The local recurrence rates were 32.4% and 28.2% respectively (P=0.80; the isolated nodal failure (INF rate were 3.0% and 2.6% respectively (P=0.91; all INF sites were in the ipsilateral supraclavicular fossa. Medastinal N3 disease was the risk factor for INF (P=0.02, OR=14.13, 95%CI: 1.47-136.13. During radiotherapy, grade I, II weight loss was observed in 29.4%, 5.9% and 56.4%, 7.7% patients respectively (P=0.04. Grade 0-I and II-III late pulmonary injury was developed in 97.1%, 2.9% and 86.4%, 15.4% patients respectively (P=0.07. Median survival time was 22.1 months and 26.9 months respectively. The 1 to 3-year OS were 77.9%, 44.4%, 37.3% and 75.8%, 56.3%, 41.7% respectively (P=0.79. Conclusion The preliminary results of this study indicate that irradiant the post-chemotherapy tumor extent (GTV-T and positive nodal drainage area did not decrease local control and overall

  14. A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

    Science.gov (United States)

    2016-07-03

    Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

  15. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    OpenAIRE

    Deepti Chopra; Rehan, Harmeet S.; Vibha Sharma; Ritu Mishra

    2016-01-01

    Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs). The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013) were studied. These reports were analyzed for various carcinoma...

  16. Prospective memory impairment in chemotherapy-exposed early breast cancer survivors: Preliminary evidence from a clinical test.

    Science.gov (United States)

    Bedard, Marc; Verma, Shailendra; Collins, Barbara; Song, Xinni; Paquet, Lise

    2016-01-01

    We report the results of a secondary analysis of a cross-sectional study (Paquet et al., 2013 ) to evaluate the cognitive operations involved in prospective memory (PM) deficits exhibited by chemotherapy-exposed breast cancer (BC) survivors. PM was assessed with the memory for intentions screening test administered to 80 patients and 80 healthy controls. Patients performed worse than controls on the PM tasks and had more "omission" errors (indices of the prospective component of the tasks) than the controls. No group differences emerged on a recognition test. Although further studies will be needed to disentangle the multiple cognitive operations involved in PM, these findings are consistent with the notion that self-initiated retrieval processes rather than encoding are implicated in PM impairment among BC survivors. PMID:27123566

  17. Prospective cohort study of febrile neutropenia in breast cancer patients with neoadjuvant and adjuvant chemotherapy: CSPOR-BC FN study.

    Science.gov (United States)

    Ishikawa, Takashi; Sakamaki, Kentaro; Narui, Kazutaka; Kaise, Hiroshi; Tsugawa, Koichiro; Ichikawa, Yasushi; Mukai, Hirofumi

    2016-07-01

    With the increasing use of adjuvant chemotherapy for treating early breast cancer, febrile neutropenia management has become crucial. Guidelines for febrile neutropenia management are mostly based on a Caucasian population survey although ethnic differences are reported in terms of adverse events. We survey the current status of febrile neutropenia and risk factors in Japanese female breast cancer patients receiving neoadjuvant and adjuvant chemotherapy regimens potential for febrile neutropenia. Subsequently, we plan to conduct a multicenter prospective cohort study involving 1000 patients with operable breast cancer. With the current state of oral antibiotics being routinely prescribed without hematology tests, we survey febrile neutropenia based on two different definitions, namely, true febrile neutropenia: ≥37.5°C and Grade 4 neutropenia, and surrogate febrile neutropenia: ≥37.5°C and oral antibiotic and antipyretic intake. The comparison of true febrile neutropenia and surrogate febrile neutropenia incidences is anticipated to provide information on the safety and feasibility of chemotherapy management without performing blood tests. PMID:27162322

  18. A randomized trial of amifostine as a cytoprotective agent in patients receiving chemotherapy for small cell lung cancer

    OpenAIRE

    Johnson, P. W. M.; Muers, M. F.; Peake, M D; Poulter, K M; Gurney, E M; Napp, V; Hepburn, P M; Brown, J. M.

    2001-01-01

    A randomized trial was conducted to determine whether administration of Amifostine with chemotherapy for small cell lung cancer could decrease the toxicity. 84 patients with small cell lung cancer of favourable prognosis (limited disease, performance status 0–1; limited disease with performance status 2 but normal sodium and alkaline phosphatase, or extensive diseas with performance status 0–1, normal sodium and alkaline phosphatase) received treatment with Ifosfamide 3 g/m2intravenously, Car...

  19. Impact of adjuvant taxane-based chemotherapy on development of breast cancer-related lymphedema: results from a large prospective cohort

    OpenAIRE

    Swaroop, Meyha N.; Ferguson, Chantal M.; Horick, Nora K.; Skolny, Melissa N; Miller, Cynthia L.; Jammallo, Lauren S; Brunelle, Cheryl L.; O’Toole, Jean A; Isakoff, Steven J.; Specht, Michelle C.; Taghian, Alphonse G.

    2015-01-01

    Taxane-based chemotherapy for the treatment of breast cancer is associated with fluid retention in the extremities; however, its association with development of breast cancer-related lymphedema is unclear. We sought to determine if adjuvant taxane-based chemotherapy increased risk of lymphedema or mild swelling of the upper extremity. 1121 patients with unilateral breast cancer were prospectively screened for lymphedema with perometer measurements. Lymphedema was defined as a relative volume ...

  20. Preventive effects of amino-acid-rich elemental diet Elental® on chemotherapy-induced oral mucositis in patients with colorectal cancer: a prospective pilot study

    OpenAIRE

    Ogata, Yutaka; Ishibashi, Nobuya; Yamaguchi, Keizou; UCHIDA, SHINJI; Kamei, Hideki; Nakayama, Goichi; Hirakawa, Hiroaki; Tanigawa, Masahiko; Akagi, Yoshito

    2015-01-01

    Purpose The prospective pilot study was designed to evaluate the preventive effects of amino-acid-rich elemental diet (ED), Elental®, on chemotherapy-induced oral mucositis in patients with colorectal cancer. The factors influencing its efficacy are also investigated. Methods A total of 22 eligible patients with colorectal cancer experiencing grade 1–3 oral mucositis during treatment with fluorouracil-based chemotherapy entered the current study. Their average age was 67 years. There were 10 ...

  1. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    NARCIS (Netherlands)

    Haren, F.M.P. van; Sleigh, J.; Boerma, E.C.; Pine, M. La; Bahr, M.; Pickkers, P.; Hoeven, J.G. van der

    2012-01-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% N

  2. Quinine improves the results of intensive chemotherapy in myelodysplastic syndromes expressing P glycoprotein: results of a randomized study.

    Science.gov (United States)

    Wattel, E; Solary, E; Hecquet, B; Caillot, D; Ifrah, N; Brion, A; Mahé, B; Milpied, N; Janvier, M; Guerci, A; Rochant, H; Cordonnier, C; Dreyfus, F; Buzyn, A; Hoang-Ngoc, L; Stoppa, A M; Gratecos, N; Sadoun, A; Stamatoulas, A; Tilly, H; Brice, P; Maloisel, F; Lioure, B; Desablens, B; Fenaux, P

    1998-09-01

    Intensive chemotherapy produces a lower complete remission (CR) rate in the myelodysplastic syndromes (MDS) than in de novo acute myeloid leukaemia (AML), possibly due in part to a higher incidence of P glycoprotein (PGP) expression in MDS blast cells. We designed a randomized trial of intensive chemotherapy with or without quinine, an agent capable of reverting the multidrug resistance (mdr) phenotype, in patients aged < or = 65 years with high-risk MDS. Patients were randomized to receive mitoxantrone 12 mg/m2/d days 2-5 + AraC 1 g/m2/12 h days 1-5, with (Q+) or without (Q-) quinine (30 mg/kg/d). 131 patients were included. PGP expression analysis was successful in 91 patients. In the 42 PGP-positive cases, 13/25 (52%) patients in the Q+ group achieved CR, compared to 3/17 (18%) patients in the Q- group (P = 0.02) and median Kaplan-Meier survival was 13 months in the Q+ group, and 8 months in the Q- group (P = 0.01). No life-threatening toxicity was observed with quinine. In conclusion, the results of this randomized study show that quinine increases the CR rate and survival in PGP-positive MDS cases treated with intensive chemotherapy. PMID:9734653

  3. Prospective Phase I-II Trial of Helical Tomotherapy With or Without Chemotherapy for Postoperative Cervical Cancer Patients

    International Nuclear Information System (INIS)

    Purpose: To investigate, in a prospective trial, the acute and chronic toxicity of patients with cervical cancer treated with surgery and postoperative intensity-modulated radiotherapy (RT) delivered using helical tomotherapy, with or without the administration of concurrent chemotherapy. Patients and Methods: A total of 24 evaluable patients entered the study between March 2006 and August 2009. The indications for postoperative RT were tumor size, lymphovascular space invasion, and the depth of cervical stromal invasion in 15 patients; 9 patients underwent postoperative RT because of surgically positive lymph nodes. All patients underwent pelvic RT delivered with helical tomotherapy and intracavitary high-dose-rate brachytherapy. Treatment consisted of concurrent weekly platinum in 17, sequential carboplatin/Taxol in 1, and RT alone in 6. The patients were monitored for acute and chronic toxicity using the Common Toxicity Criteria, version 3.0. Results: The median follow-up was 24 months (range, 4–49). At the last follow-up visit, 23 patients were alive and disease free. Of the 24 patients, 12 (50%) experienced acute Grade 3 gastrointestinal toxicity (anorexia in 5, diarrhea in 4, and nausea in 3). One patient developed acute Grade 4 genitourinary toxicity (vesicovaginal fistula). For patients treated with concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 71% and 24%, respectively. For patients treated without concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 29% and 14%, respectively. Two long-term toxicities occurred (vesicovaginal fistula at 25 months and small bowel obstruction at 30 months). The overall and progression-free survival rate at 3 years for all patients was 100% and 89%, respectively. Conclusion: The results of our study have shown that postoperative external RT for cervical cancer delivered with helical tomotherapy and high-dose-rate brachytherapy and with or without

  4. Prospective Phase I-II Trial of Helical Tomotherapy With or Without Chemotherapy for Postoperative Cervical Cancer Patients

    Energy Technology Data Exchange (ETDEWEB)

    Schwarz, Julie K., E-mail: jschwarz@radonc.wustl.edu [Department of Radiation Oncology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Department of Cell Biology and Physiology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO (United States); Wahab, Sasa [Cobb Center for Radiation Oncology Center, Austell, GA (United States); Grigsby, Perry W. [Department of Radiation Oncology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO (United States); Division of Nuclear Medicine, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Department of Obstetrics and Gynecology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States)

    2011-12-01

    Purpose: To investigate, in a prospective trial, the acute and chronic toxicity of patients with cervical cancer treated with surgery and postoperative intensity-modulated radiotherapy (RT) delivered using helical tomotherapy, with or without the administration of concurrent chemotherapy. Patients and Methods: A total of 24 evaluable patients entered the study between March 2006 and August 2009. The indications for postoperative RT were tumor size, lymphovascular space invasion, and the depth of cervical stromal invasion in 15 patients; 9 patients underwent postoperative RT because of surgically positive lymph nodes. All patients underwent pelvic RT delivered with helical tomotherapy and intracavitary high-dose-rate brachytherapy. Treatment consisted of concurrent weekly platinum in 17, sequential carboplatin/Taxol in 1, and RT alone in 6. The patients were monitored for acute and chronic toxicity using the Common Toxicity Criteria, version 3.0. Results: The median follow-up was 24 months (range, 4-49). At the last follow-up visit, 23 patients were alive and disease free. Of the 24 patients, 12 (50%) experienced acute Grade 3 gastrointestinal toxicity (anorexia in 5, diarrhea in 4, and nausea in 3). One patient developed acute Grade 4 genitourinary toxicity (vesicovaginal fistula). For patients treated with concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 71% and 24%, respectively. For patients treated without concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 29% and 14%, respectively. Two long-term toxicities occurred (vesicovaginal fistula at 25 months and small bowel obstruction at 30 months). The overall and progression-free survival rate at 3 years for all patients was 100% and 89%, respectively. Conclusion: The results of our study have shown that postoperative external RT for cervical cancer delivered with helical tomotherapy and high-dose-rate brachytherapy and with or without

  5. The Effect of Aloe Vera Solution on Chemotherapy-Induced Stomatitis in Clients with Lymphoma and Leukemia: A Randomized Controlled Clinical Trial

    OpenAIRE

    Parisa Mansouri; Maryam Haghighi; Noushin Beheshtipour; Mani Ramzi

    2016-01-01

    Background: Stomatitis is the most common complication of chemotherapy. This study aimed to assess the effect of aloe vera solution on stomatitis and its pain intensity in patients undergoing chemotherapeutic procedures. Methods: In this randomized controlled clinical trial, 64 patients with Acute Myeloid Leukemia and Acute Lymphocytic Leukemia undergoing chemotherapy were randomly divided into a control and an intervention group. The intervention group patients were asked to wash their mo...

  6. Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study

    International Nuclear Information System (INIS)

    Preventing chemotherapy-induced thrombocytopenia could avoid chemotherapy dose reductions and delays. The safety and maximum tolerated dose of eltrombopag, an oral thrombopoietin receptor agonist, with gemcitabine-based therapy was evaluated. Patients with advanced solid tumors and platelets ≤300 × 109/L receiving gemcitabine plus cisplatin or carboplatin (Group A) or gemcitabine monotherapy (Group B) were randomized 3:1 to receive eltrombopag or placebo at a starting dose of 100 mg daily administered on days −5 to −1 and days 2–6 starting from cycle 2 of treatment. Nineteen patients (Group A, n = 9; Group B, n = 10) received eltrombopag 100 mg and seven (Group A, n = 3; Group B, n = 4) received matching placebo. Nine eltrombopag patients in Group A and eight in Group B had 38 and 54 occurrences of platelet counts ≥400 × 109/L, respectively. Mean platelet nadirs across cycles 2–6 were 115 × 109/L and 143 × 109/L for eltrombopag-treated patients versus 53 × 109/L and 103 × 109/L for placebo-treated patients in Groups A and B, respectively. No dose-limiting toxicities were reported for eltrombopag; however, due to several occurrences of thrombocytosis, a decision was made not to dose-escalate eltrombopag to >100 mg daily. In Groups A and B, 14% of eltrombopag versus 50% of placebo patients required chemotherapy dose reductions and/or delays for any reason across cycles 3–6. Eltrombopag 100 mg once daily administered 5 days before and after day 1 of chemotherapy was well tolerated with an acceptable safety profile, and will be further tested in a phase II trial. Fewer patients receiving eltrombopag required chemotherapy dose delays and/or reductions compared with those receiving placebo

  7. Post-treatment intellectual functioning in children treated for acute lymphoblastic leukaemia (ALL) with chemotherapy-only : A prospective, sibling-controlled study

    NARCIS (Netherlands)

    Jansen, Nathalie C.; Kingma, Annette; Schuitema, Arnout; Bourma, Anke; Huisman, Jaap; Veerman, Anjo J.; Kamps, Willem A.; Bouma, A

    2006-01-01

    intellectual functioning (verbal, performance and full-scale IQ) in 43 children treated for acute lymphoblastic leukaemia (ALL) with chemotherapy-only was evaluated in a nationwide, prospective, sibling-controlled study. Intellectual assessment was performed at diagnosis and repeated shortly after c

  8. Role of p-glycoprotein expression in predicting response to neoadjuvant chemotherapy in breast cancer-a prospective clinical study

    Directory of Open Access Journals (Sweden)

    Bhatia Ashima

    2005-09-01

    Full Text Available Abstract Background Neoadjuvant chemotherapy (NACT is an integral part of multi-modality approach in the management of locally advanced breast cancer. It is vital to predict response to chemotherapy in order to tailor the regime for a particular patient. The prediction would help in avoiding the toxicity induced by an ineffective chemotherapeutic regime in a non-responder and would also help in the planning of an alternate regime. Development of resistance to chemotherapeutic agents is a major problem and one of the mechanisms considered responsible is the expression of 170-k Da membrane glycoprotein (usually referred to as p-170 or p-glycoprotein, which is encoded by multidrug resistance (MDR1 gene. This glycoprotein acts as an energy dependent pump, which actively extrudes certain families of chemotherapeutic agents from the cells. The expression of p-glycoprotein at initial presentation has been found to be associated with refractoriness to chemotherapy and a poor outcome. Against this background a prospective study was conducted using C219 mouse monoclonal antibody specific for p-glycoprotein to ascertain whether pretreatment detection of p-glycoprotein expression could be utilized as a reliable predictor of response to neoadjuvant chemotherapy in patients with breast cancer. Patients and methods Fifty cases of locally advanced breast cancer were subjected to trucut® biopsy and the tissue samples were evaluated immunohistochemically for p-glycoprotein expression and ER, PR status. The response to neoadjuvant chemotherapy was assessed clinically and by using ultrasound after three cycles of FAC regime (cyclophosphamide 600 mg/m2, Adriamycin 50 mg/m2, 5-fluorourail 600 mg/m2 at an interval of three weeks. The clinical response was correlated with both the pre and post chemotherapy p-glycoprotein expression. Descriptive studies were performed with SPSS version 10. The significance of correlation between tumor response and p

  9. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    Directory of Open Access Journals (Sweden)

    Deepti Chopra

    2016-01-01

    Full Text Available Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs. The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013 were studied. These reports were analyzed for various carcinomas under treatment, medications used, types of ADRs, organ system involvement, severity, causality assessment, and preventability. Results: Over a period of 2 years, a total 591 cases were received with an incidence of 58.6%. The prevalence of ADRs was more in female patients (73.6% as compared to men. ADRs mostly occurred in the age group of 41-50 years (27.4%. Patients treated for breast carcinoma (39.1% reported the highest incidence of ADRs. Cisplatin (19.6% was found to be the most common offending drug. The most common ADR reported was nausea and vomiting (23%. Gastroenterology (40.1% was the most affected system. About 50.2% of the ADRs required treatment and 12.9% ADRs were considered serious. Causality assessment revealed that 80% of the ADRs were possible. About 86.97% cases were found to be mild, and 51% were not preventable. Conclusion: The success of chemotherapy comes with the word of caution regarding toxicities of antineoplastic drugs. Pharmacovigilance of these drugs needs to be explored, and use of preventative measures needs to be enhanced in order to reduce the incidence and severity of ADRs.

  10. Comparison of Rifaximin and Lactulose for the Treatment of Hepatic Encephalopathy: A Prospective Randomized Study

    OpenAIRE

    Paik, Yong-Han; Lee, Kwan Sik; Han, Kwang-Hyub; Song, Kun Hoon; Kim, Myoung Hwan; Moon, Byung Soo; Ahn, Sang Hoon; Lee, Se Joon; Park, Hyo Jin; Lee, Dong Ki; Chon, Chae Yoon; Lee, Sang In; Moon, Young Myoung

    2005-01-01

    Rifaximin has been reported to be effective for the treatment of hepatic encephalopathy (HE) in Europe. However, it is unknown whether Rifaximin is effective for the treatment of HE in Koreans, therefore we conducted a open-label prospective randomized study to evaluate the efficacy of rifaximin versus lactulose in Korean patients. Fifty-four patients with liver cirrhosis and hepatic encephalopathy were enrolled. Thirty-two patients were randomized to receive rifaximin and 22 to receive lactu...

  11. Long-term outcome of irradiation with or without chemotherapy for esophageal squamous cell carcinoma: a final report on a prospective trial

    International Nuclear Information System (INIS)

    To investigate the long-term outcome of esophageal squamous cell carcinoma (SCC) treated by irradiation with or without concurrent chemotherapy. A prospective clinical trial was carried out from 1998 to 2000. One hundred and eleven patients were randomly enrolled to receive either late course accelerated hyperfractionated irradiation (LCAF) or LCAF with concurrent chemotherapy (LCAF + CT). For LCAF, 41.4 Gy in 23 fractions was first delivered at five fractions per week, followed by 27 Gy in 18 fractions at two 1.5 Gy fractions a day. Concurrent chemotherapy of cis-platinum and 5-fluorouracil was administered for four cycles. Overall survival (OS), locoregional recurrence and distant metastasis were observed. Late toxicity was scored by RTOG criteria, and quality of life (QOL) was also evaluated. The median follow-up time was 24 months for all patients and 138 months for 17 living patients. Median survival time was 25 months and 32 months in LCAF and LCAF + CT (p = 0.653), respectively. For an entire group of patients, overall survivals were 34%, 27% and 22%; locoregional recurrence rates were 30%, 36% and 41%; and distant metastasis rates were 26%, 28% and 29% at 5-yr, 8-yr and 10-yr, respectively. Incidences of ≥ Grade 3 late toxicity were 29% at 10-yr. There were no statistically significant differences between LCAF and LCAF + CT with respect to the parameters mentioned above. Cumulative incidence of late toxicities of ≥ Grade 3 increased sharply after the attained age of 70 years. Eighty-eight percent of patients lived with good KPS (≥ 90) and 94% could eat regular or soft diet. The long-term outcome of esophageal SCC patients who received LCAF or LCAF + CT was good. The locoregional and distant failures occurred more often in the first three years after treatment, but could continuously occur up to 10 years. The late toxicity was acceptable. Late toxicities ≥ Grade 3 were more likely to occur in elderly patients. QOL was good in living patients

  12. Understanding breast cancer patients' preference for two types of exercise training during chemotherapy in an unblinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vallance Jeffrey K

    2008-10-01

    Full Text Available Abstract Background Patient preference for group assignment may affect outcomes in unblinded trials but few studies have attempted to understand such preferences. The purpose of the present study was to examine factors associated with breast cancer patients' preference for two types of exercise training during chemotherapy. Methods Breast cancer patients (N = 242 completed a battery of tests including a questionnaire that assessed patient preference and the theory of planned behavior (TPB prior to being randomized to usual care, resistance exercise training (RET, or aerobic exercise training (AET. Results 99 (40.9% participants preferred RET, 88 (36.4% preferred AET, and 55 (22.7% reported no preference. Past exercisers (p = 0.023, smokers (p = 0.004, and aerobically fitter participants (p = 0.005 were more likely to prefer RET. As hypothesized, participants that preferred AET had more favorable TPB beliefs about AET whereas participants that preferred RET had more favorable TPB beliefs about RET. In multivariate modeling, patient preference for RET versus AET was explained (R2 = .46; p 2 = .48; p Conclusion Breast cancer patients' preference for RET versus AET during chemotherapy was predicted largely by a difference in motivation for each type of exercise which, in turn, was based on differences in their beliefs about the anticipated benefits, enjoyment, and difficulty of performing each type of exercise during chemotherapy. These findings may help explain patient preference effects in unblinded behavioral trials. Trial Registration ClinicalTrials.gov Identifier NCT00115713.

  13. A randomized controlled study evaluating the efficacy of aprepitant for highly/moderately emetogenic chemotherapies in hematological malignancies.

    Science.gov (United States)

    Nasu, R; Nannya, Y; Kurokawa, M

    2015-04-01

    Chemotherapy-induced nausea and vomiting (CINV) is a serious complication of treatments of hematological malignancies. Although aprepitant, an NK1 receptor antagonist, has been shown to control CINV in highly emetogenic therapies for solid tumors, the antiemetic effect of this agent in hematological chemotherapies is not well established. In this randomized controlled trial, we examined the additional effect of aprepitant in combination with conventional 5HT3 blocker-based prophylaxis for CINV in highly or moderately emetic chemotherapies for hematological malignancies (n = 41). The complete response rate, defined as no emetic episodes and no salvage treatments, was significantly higher in the aprepitant arm than the control arm (82 versus 47 %, p = 0.026), with no increase in severe adverse effects. However, the difference of nausea, measured with visual analog scale, and of oral intake impairment was moderate, which suggests insufficiency of blocking NK receptor for these events. Furthermore, sub-group analysis revealed that merit of aprepitant addition depends on treatment regimens. Our results indicate the overall advantage of applying aprepitant in the control of CINV in hematological malignancies and the need for further refinement of anti-CINV strategies, including stratification according to regimen. PMID:25644148

  14. Efficacy and Safety of Oral Lactoferrin Supplementation in Combination with rHuEPO-β for the Treatment of Anemia in Advanced Cancer Patients Undergoing Chemotherapy: Open-Label, Randomized Controlled Study

    Science.gov (United States)

    Madeddu, Clelia; Gramignano, Giulia; Mulas, Carlo; Sanna, Eleonora; Mantovani, Giovanni

    2010-01-01

    Advanced-stage cancer patients often suffer from anemia that closely resembles the anemia of chronic inflammatory diseases characterized by specific changes in iron homeostasis and absorption. i.v. iron improves the efficacy of recombinant human erythropoietin (rHuEPO) in anemic cancer patients undergoing chemotherapy. We report the results of an open-label, randomized, prospective trial aimed at testing the efficacy and safety of treatment with oral lactoferrin versus i.v. iron, both combined with rHuEPO, for the treatment of anemia in a population of 148 advanced cancer patients undergoing chemotherapy. All patients received s.c. rHuEPO-β, 30,000 UI once weekly for 12 weeks, and were randomly assigned to ferric gluconate (125 mg i.v. weekly) or lactoferrin (200 mg/day). Both arms showed a significant hemoglobin increase. No difference in the mean hemoglobin increase or the hematopoietic response, time to hematopoietic response, or mean change in serum iron, C-reactive protein, or erythrocyte sedimentation rate were observed between arms. In contrast, ferritin decreased in the lactoferrin arm whereas it increased in the i.v. iron arm. In conclusion, these results show similar efficacy for oral lactoferrin and for i.v. iron, combined with rHuEPO, for the treatment of anemia in advanced cancer patients undergoing chemotherapy. PMID:20647390

  15. Concomitant boost radiation therapy for inoperable non-small-cell lung cancer: preliminary report of a prospective randomized study

    International Nuclear Information System (INIS)

    Purpose: The radiation therapy results for patients with inoperable non-small-cell lung cancer (NSCLC) have been disappointing. Tumor dose escalation using concomitant boost technique (CBT) has been shown to improve local control in a few prospective studies. This trial was carried out to prospectively assess the radiation response and acute toxicity of CBT in comparison to the conventional treatment technique (CTT). Methods and Materials: Ninety-seven consecutive eligible patients were entered in this prospective clinical trial between November 1994 and February 1998. Patients were randomized to receive either CBT (43 patients) or CTT (54 patients) radiation therapy. These patients either refused chemotherapy or were judged as unsuitable for chemotherapy. Patients in the CBT group received 46.8 Gy in 26 fractions using large fields that encompassed the gross and occult disease. A concomitant boost of 18.2 Gy (0.7 Gy per fraction) was delivered to the gross disease using small fields with 1.5-cm margins. The small fields were treated concurrently with the large fields and the total dose to the tumor area was 65 Gy in 26 fractions. Patients in the CTT group received 70.8 Gy in 38 fractions. The acute toxicity between each group was compared. The response rate was analyzed and compared by treatment group, gender, age, stage, histology, initial Karnofsky performance score (KPS), severity of acute toxicity, and maximum body weight loss (MBWL) during treatment course. Results: The demographic parameters such as sex, age, and stage were evenly distributed in each treatment group. The majority of these patients had Stage IIIA and IIIB disease. Overall median treatment times were 39 days for the CBT group of patients and 62 days for the CTT group. No treatment-related mortality was found. There were 2 patients in the CTT group with acute RTOG Grade 3 lung toxicity, and no Grade 3 lung or esophageal toxicity was observed in CBT group. The response rates, assessed by

  16. Radiotherapy and chemotherapy in the treatment of head and neck cancer: results after five years of a randomized study

    International Nuclear Information System (INIS)

    Purpose: this study was undertaken to evaluate the efficacy of two regimens of chemoradiotherapy in the treatment of locally advanced head and neck cancer. Methods: from 1992 to 1997, 127 patients with locally advanced head and neck cancer (stage III-IV) were randomized. Sixty-six patients (group a), 42 male and 24 female, with a median age of 48 years (range 40-72) received during radiotherapy two courses (1.-6. week) of chemotherapy with carbo-platin (300 mg/m2 day 1) and etoposide (60 mg/m2 days 1 to 3). Sixty-one patients (group b), 40 male and 21 female, with a median age of 51 years (range 42-69) received two cycles of chemotherapy with 5 FU (750 mg/m2 days 1 to 5) and MIT C ( 10 mg/m2 day 1). The median dose of radiotherapy was 60 Gy (range 55-66 Gy) 180 cGy /d 5w. Results: the actuarial five-year survival rate (Kaplan-Meier) was 38 % for group a (CBDCA+etoposide+RT) and 25 % for group b (5FU+MIT C+RT). The difference was statistically significant (p = 0.036). Toxicity group a: mucositis G III in 41 patients and G IV in 16; dysphagia G III in 46 patients and IV in 5; leukopenia in 24 patients; 28 patients required nutritional therapy. Toxicity group b: mucositis G III in 38 patients and G IV in 17; dysphagia G III in 48 patients and G IV in 3; leukopenia in 23 patients; 25 patients needed nutritional therapy. Conclusions: the data of the actuarial survival five-year rate suggest that concomitant chemotherapy in group a (CBDCA+etoposide+RT) is better than the concomitant chemotherapy in group b (5FU+MIT C+RT). (author)

  17. Intensive Insulin Therapy in Severely Burned Pediatric Patients: A Prospective Randomized Trial

    OpenAIRE

    Jeschke, Marc G.; Kulp, Gabriela A; Kraft, Robert; Finnerty, Celeste C.; Mlcak, Ron; Lee, Jong O; Herndon, David N

    2010-01-01

    Rationale: Hyperglycemia and insulin resistance have been shown to increase morbidity and mortality in severely burned patients, and glycemic control appears essential to improve clinical outcomes. However, to date no prospective randomized study exists that determines whether intensive insulin therapy is associated with improved post-burn morbidity and mortality.

  18. Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial

    DEFF Research Database (Denmark)

    Francis, P.; Crown, J.; Di, Leo A.;

    2008-01-01

    of doxorubicin and docetaxel. METHODS: Patients with lymph node-positive breast cancer (n = 2887) were randomly assigned to one of four treatments: 1) sequential control (four cycles of doxorubicin at 75 mg/m2, followed by three cycles of cyclophosphamide, methotrexate, and 5-fluorouracil [CMF]); 2......BACKGROUND: Docetaxel is more effective than doxorubicin for patients with advanced breast cancer. The Breast International Group 02-98 randomized trial tested the effect of incorporating docetaxel into anthracycline-based adjuvant chemotherapy and compared sequential vs concurrent administration...... (four cycles of doxorubicin at 50 mg/m2 plus docetaxel at 75 mg/m2, followed by three cycles of CMF). The primary comparison evaluated the efficacy of including docetaxel regardless of schedule and was planned after 1215 disease-free survival (DFS) events (ie, relapse, second primary cancer, or death...

  19. A randomized, prospective study of adjunctive Ampicillin in preterm labor

    Directory of Open Access Journals (Sweden)

    Tehranian A

    1999-09-01

    Full Text Available Acute amniotic fluid infection has emerged as a possible cause of many heretofore unexplained preterm births. Our purpose was to determine the effect of ampicillin in the prolongation of pregnancies receiving tocolysis for preterm labor. A blinded, placebo-controlled, randomized trial was conducted to study ampicillin in women hospitalized for preterm labor between 24 and 37 weeks' gestation. A total of 60 patients with intact membranes and without chorioamnionitis who were receiving magnesium sulfate were screened. Thirty women with preterm labor received ampicillin, and 30 received placebos. The primary end point was prolongation of gestation. There was no difference in age of delivery (37.6±9.7 days vs 36.08±3.9 days, P=0.085 and no difference in retardation of delivery (4.7±3.1 vs 4.1±2.1, P=0.39. The mean degree of preterm delivery were 0.62±1.93 and 1.8±3.3 weeks in ampicillin and placebo groups, respectively (not significant, P>0.1. Conclusions: Ampicillin had no effect on interval to delivery or duration of pregnancy in women treated for preterm labor. So rotine clinical use of ampicillin during tocolysis should not be recommended.

  20. Randomized Controlled Trial of Zoledronic Acid plus Chemotherapy versus Chemotherapy Alone as Neoadjuvant Treatment of HER2-Negative Primary Breast Cancer (JONIE Study.

    Directory of Open Access Journals (Sweden)

    Yoshie Hasegawa

    Full Text Available Zoledronic acid (ZOL is a nitrogen-containing bisphosphonate that induces osteoclast apoptosis and inhibits bone resorption by inhibiting the mevalonate pathway. Its benefit for the prevention of skeletal complications due to bone metastases has been established. However, the antitumor efficacy of ZOL, although suggested by multiple preclinical and clinical studies, has not yet been clinically proven. We performed the present randomized Phase 2 trial to investigate the antitumor effect of ZOL with chemotherapy (CT.Asian patients with HER2-negative invasive breast cancer were randomly assigned to either the CT or CT+ZOL (CTZ group. One hundred and eighty-eight patients were randomized to either the CT group (n = 95 or the CTZ group (n = 93 from March 2010 to April 2012, and 180 patients were assessed. All patients received four cycles of FEC100 (fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2, followed by 12 cycles of paclitaxel at 80 mg/m2 weekly. ZOL (4 mg was administered three to four times weekly for 7 weeks to the patients in the CTZ group. The primary endpoint was the pathological complete response (pCR rate, which was defined as no invasive cancer in the breast tissue specimen. Safety was assessed in all patients who received at least one dose of the study drug.This randomized controlled trial indicated that the rates of pCR in CTZ group (14.8% was doubled to CT group (7.7%, respectively (one-sided chi-square test, p = 0.068, though the additional efficacy of zoledronic acid was not demonstrated statistically. The pCR rate in postmenopausal patients was 18.4% and 5.1% in the CTZ and CT groups, respectively (one-sided Fisher's exact test, p = 0.071, and that in patients with triple-negative breast cancer was 35.3% and 11.8% in the CTZ and CT groups, respectively (one-sided Fisher's exact test, p = 0.112. Thus the addition of ZOL to neoadjuvant CT has potential anticancer benefits in postmenopausal patients and

  1. Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma

    OpenAIRE

    Zhong, Lai-ping; Zhang, Chen-Ping; Ren, Guo-xin; Guo, Wei; William, William N.; Hong, Christopher S.; Sun, Jian; ZHU, HAN-GUANG; Tu, Wen-yong; Li, Jiang; Cai, Yi-li; Yin, Qiu-ming; WANG, LI-ZHEN; Wang, Zhong-he; Hu, Yong-jie

    2015-01-01

    Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75m...

  2. Effect of Agaricus sylvaticus supplementation on nutritional status and adverse events of chemotherapy of breast cancer: A randomized, placebo-controlled, double-blind clinical trial

    OpenAIRE

    Fabiana Valadares; Maria Rita Carvalho Garbi Novaes; Roberto Cañete

    2013-01-01

    Background: Breast cancer (BC) represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. Aim: To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. Materials and Methods: A randomized, placebo-controlled, double-blind, clini...

  3. The impact of consolidative radiotherapy in patients with 'stage IV' breast cancer who achieve a complete response to induction chemotherapy randomized ±high dose chemotherapy with autologous bone marrow transplant

    International Nuclear Information System (INIS)

    Purpose: To determine the impact of consolidative radiation therapy (RT) in patients with 'stage IV' breast cancer treated on a prospective single institution randomized trial with systemic AFM (Adriamycin, 5-FU, Methotrexate) ± high dose chemotherapy (HDCT: Cytoxan, Cisplatin, Carmustine) and ABMT (autologous bone marrow transplant). Methods: Between 1988 and 1995, 425 patients with 'stage IV' breast cancer (either local-regionally advanced/recurrent or distant disease) received induction AFM as outlined below. The 100 patients who achieved a complete response to induction AFM were randomized to receive HDCT/ABMT or observation, with HDCT/ABMT at relapse. Following HDCT/ABMT, most patients received RT to initially involved sites of disease and regional areas at risk (typically 45-60 Gy/1.8-2.0 Gy/fraction). RT was not planned for the observation group, although a few received it. The delivery of RT was not randomized. The impact of RT on control at involved sites and disease-free survival was assessed in the groups as outlined in the diagram (excluding salvage therapy). Control at previously involved sites was scored with aggressive radiologic and clinical evaluation at the time of first failure or most recent follow up. Comparisons were made using 2-tailed chi-square test. The irradiated and unirradiated groups were similar with regard to the mean number of involved sites and the fraction of patients with only local/regional disease. Results: To date, the analysis of 50 randomized patients has been completed as shown below. RT was delivered to(16(50)) patients, 12 to all sites and 4 to most sites of initial involvement. Control at all previously involved sites was(13(16)) (81%) among irradiated patients vs (7(34)) (21%) in the unirradiated group (p = 0.01). Median disease free survivals (DFS) were 20 months and 4.5 months in the +RT and -RT groups, respectively (figure). (6(50)) evaluated patients remain disease free 3-5 years following randomization (median

  4. A bladder preservation regimen using intra-arterial chemotherapy and radiotherapy for invasive bladder cancer. A prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Miyanaga, Naoto; Akaza, Hideyuki [Tsukuba Univ., Ibaraki (Japan). Inst. of Clinical Medicine; Okumura, Toshiyuki [and others

    2000-02-01

    A prospective study was performed to investigate combined treatment with intra-arterial chemotherapy and radiation therapy for bladder preservation in locally invasive bladder cancer. Patients with invasive bladder cancer, stage T2-3N0M0, were included in the study. lntra-arterial chemotherapy was performed with three injections of methotrexate and cisplatin at 3-week intervals. Simultaneously, the patients underwent X-ray irradiation (40 Gy) of the small pelvic space. Where a post-treatment transurethral resection (TUR) biopsy showed no residual tumor, the tumor site was irradiated by a 30 Gy proton beam and the bladder was preserved. Where tumors remained, radical cystectomy was performed. Between 1990 and 1996, 42 patients were treated according to this protocol. Post-treatment TUR biopsy and urine cytology showed no residual tumors in 39 of 42 cases (93%). The bladder was preserved in accordance with the study protocol in 36 cases. A median follow-up of 38 months showed 3-year non-recurrence in 72% of bladder-preserved patients and the rate of bladder preservation was 84%. The nine recurrences included eight cases of superficial bladder recurrence. One cancer death occurred among the bladder-preservation patients, giving 3-year survival and cause-specific survival rates of 84% and 100%, respectively. Although bladder function decreased slightly in compliance, bladder capacity was retained in almost all cases. This regimen is useful for bladder preservation in T2-3 locally invasive bladder cancer. Information from more cases and the results of more long-term observations are needed, as is an evaluation of appropriate subject selection and factors associated with quality of life issues, particularly regarding bladder function. (author)

  5. A prospective cohort study of the effects of adjuvant breast cancer chemotherapy on taste function, food liking, appetite and associated nutritional outcomes.

    Directory of Open Access Journals (Sweden)

    Anna Boltong

    Full Text Available 'Taste' changes are commonly reported during chemotherapy. It is unclear to what extent this relates to actual changes in taste function or to changes in appetite and food liking and how these changes affect dietary intake and nutritional status.This prospective, repeated measures cohort study recruited participants from three oncology clinics. Women (n = 52 prescribed adjuvant chemotherapy underwent standardised testing of taste perception, appetite and food liking at six time points to measure change from baseline. Associations between taste and hedonic changes and nutritional outcomes were examined.Taste function was significantly reduced early in chemotherapy cycles (p<0.05 but showed recovery by late in the cycle. Ability to correctly identify salty, sour and umami tastants was reduced. Liking of sweet food decreased early and mid-cycle (p<0.01 but not late cycle. Liking of savory food was not significantly affected. Appetite decreased early in the cycle (p<0.001. Reduced taste function was associated with lowest kilojoule intake (r = 0.31; p = 0.008 as was appetite loss with reduced kilojoule (r = 0.34; p = 0.002 and protein intake (r = 0.36; p = 0.001 early in the third chemotherapy cycle. Decreased appetite early in the third and final chemotherapy cycles was associated with a decline in BMI (p = <0.0005 over the study period. Resolution of taste function, food liking and appetite was observed 8 weeks after chemotherapy completion. There was no association between taste change and dry mouth, oral mucositis or nausea.The results reveal, for the first time, the cyclical yet transient effects of adjuvant chemotherapy on taste function and the link between taste and hedonic changes, dietary intake and nutritional outcomes. The results should be used to inform reliable pre-chemotherapy education.

  6. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    OpenAIRE

    Yu Zhang; Hao-Ping Zhu; Jian-Xia Fan; Hong Yu; Li-Zhou Sun; Lian Chen; Qing Chang; Nai-Qing Zhao; Wen Di

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized...

  7. Randomized controlled trials of postoperative chemoradiotherapy versus chemotherapy alone in patients with gastric cancer: a meta-analysis

    International Nuclear Information System (INIS)

    Objective: To compare the efficacy and safety between postoperative chemoradiotherapy and postoperative chemotherapy alone in patients with gastric cancer by a meta-analysis of randomized controlled trials (RCTs). Methods: Chinese Scientific Journal Full-Text Database (January 1979-June 2013), VIP (January 1989-June 2013), Chinese Biomedical Literature Database (January 1978-June 2013), Cochrane Library (Issue 6,2013), PubMed (January 1966-June 2013), and EMBASE (January 1974-June 2013) were searched to identify RCTs of postoperative chemoradiotherapy versus chemotherapy alone in patients with gastric cancer. The obtained data were analyzed using RevMan 5.2 and Stata 12. The difference between two groups was estimated by calculating the risk ratio (RR) with 95% confidence interval (CI). Results: A total of 1 143 patients from 11 RCTs were included in the meta-analysis according to the inclusion and exclusion criteria. Our results showed that postoperative chemoradiotherapy significantly increased 1-, 2-, and 3-year overall survival rates (RR=1.20, 95% CI=1.10-1.30, P=0.00; RR=1.34, 95% CI=1.16-1.56, P=0.00; RR=2.62, 95% CI=1.72-3.97, P=0.00) and 3-and 5-year disease-free survival rates (RR=1.10, 95% CI =1.00-1.21, P=0.04; RR=1.27, 95% CI=1.02-1.60, P=0.04). The incidence of grade 3 or 4 gastrointestinal tract reactions,liver function impairment, bone marrow suppression,and hand-foot syndrome was low and showed little difference between two groups (P =0.03-0.78). Conclusions: Postoperative chemoradiotherapy can prolong the survival of patients with gastric cancer, and the patients have good tolerance to chemotherapy drugs. (authors)

  8. A prospective cohort study of early discontinuation of adjuvant chemotherapy in women with breast cancer: the breast cancer quality of care study (BQUAL).

    Science.gov (United States)

    Neugut, Alfred I; Hillyer, Grace Clarke; Kushi, Lawrence H; Lamerato, Lois; Buono, Donna L; Nathanson, S David; Bovbjerg, Dana H; Mandelblatt, Jeanne S; Tsai, Wei-Yann; Jacobson, Judith S; Hershman, Dawn L

    2016-07-01

    For many women with non-metastatic breast cancer, adjuvant chemotherapy prevents recurrence and extends survival. Women who discontinue chemotherapy early may reduce those benefits, but little is known about what predicts early discontinuation. We sought to determine prospectively the rate and reasons for early discontinuation of adjuvant chemotherapy in women with breast cancer. We conducted a prospective cohort study among three U.S. health care organizations. Of 1158 women with newly diagnosed non-metastatic breast cancer, 2006-2010, we analyzed 445 (38.4 %) patients who initiated standard adjuvant chemotherapy as defined by accepted guidelines. We interviewed patients at baseline and twice during treatment regarding sociodemographic/psychosocial factors and treatment decision-making and collected clinical data. They were categorized according to the number of cycles required by the chemotherapy regimen they had initiated. The outcome was early discontinuation (4 cycles of therapy (18.1 % for longer regimens, 7.4 % for 4 cycles) (odds ratio [OR] 2.59, 95 % CI 1.32-5.08), controlling for race, age, stage, hormone receptor status, social support, optimism, spirituality, stress, and physical symptoms. Higher levels of psychological symptoms on the Memorial symptom assessment scale also increased the odds of early discontinuation (OR 1.92, 95 % CI 0.998-3.68). The large majority of patients who initiated adjuvant chemotherapy for breast cancer completed their prescribed regimens, but early discontinuation was associated with lengthier regimens and, with borderline statistical significance, for those with psychological side effects. PMID:27287779

  9. Neo-adjuvant chemotherapy plus surgery versus surgery alone for cervical cancer: Meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Peng, Yun-Hua; Wang, Xin-Xiu; Zhu, Jing-Song; Gao, Li

    2016-02-01

    The aim of this study was to evaluate the efficacy and safety of neo-adjuvant chemotherapy (NACT) versus radical surgery (RS) for patients with cervical cancer. A meta-analysis of randomized controlled trials (RCT) of NACT + RS versus RS alone for patients with cervical cancer was performed according to the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. The following electronic databases were searched from their inception to April 2015: PUBMED, EMBASE and Cochrane Library. Statistical analysis was done using REVIEW MANAGER 5.3. Five RCT involving 739 patients were studied. There were significant differences between the NACT + RS and the RS-alone groups for positive lymph nodes (OR, 0.45; 95%CI: 0.29-0.70) and parametrial infiltration (OR, 0.48; 95% CI: 0.25-0.92), while treatment efficacy did not differ significantly for 5-year overall survival rate (OR, 1.17; 95% CI: 0.85-1.61), 5-year disease-free survival rate (OR, 1.09; 95% CI: 0.77-1.56) or recurrence rate (OR, 1.17; 95% CI: 0.85-1.61). The results also indicated that chemotherapy-related toxicity was well tolerated. For patients with cervical cancer, NACT could significantly reduce the number of positive lymph nodes and the level of parametrial infiltration compared with RS alone, and be well tolerated. PMID:26807961

  10. Hyperthermic intra-peritoneal chemotherapy using Oxaliplatin as consolidation therapy for advanced epithelial ovarian carcinoma. Results of a phase II prospective multicentre trial. CHIPOVAC study

    OpenAIRE

    Pomel, Christophe; Ferron, Gwenaël; Lorimier, Gérard; Rey, Annie; Lhomme, Catherine; Classe, Jean Marc; Bereder, J.M.; Quenet, François; Meeus, Pierre; Marshall, Frederic; Morice, Philippe; Elias, Dominique

    2010-01-01

    Abstract Introduction The aim of the present study was to prospectively evaluate morbidity of intra-peritoneal hyper-thermic chemotherapy (HIPEC) using Oxaliplatin as consolidation therapy for advanced epithelial ovarian carcinoma and, secondly, to study peritoneal recurrence. Methods Between 2004 and 2007, 31 patients from 18 to 65 years with FIGO stage IIIC epithelial ovarian carcinoma were treated by surgery and a total of 6 cycles of platinum ba...

  11. Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study

    OpenAIRE

    Łukasz Szarpak; Andrzej Kurowski

    2014-01-01

    Background: Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological material. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. Materials and Methods: In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vesse...

  12. Early Bactericidal Activity of Moxifloxacin in Treatment of Pulmonary Tuberculosis: a Prospective, Randomized Study

    OpenAIRE

    Pletz, Mathias W. R.; De Roux, Andres; Roth, Andreas; NEUMANN, Karl-Heinz; Mauch, Harald; Lode, Hartmut

    2004-01-01

    Moxifloxacin is the most active fluoroquinolone against Mycobacterium tuberculosis in vitro. However, data about the efficacy in patients are not available. We enrolled 17 patients with tuberculosis in a prospective, randomized study. After 5 days of monotherapy with either moxifloxacin or isoniazid, we detected significant decreases in mean CFU per milliliter in sputum in both groups. The calculated early bactericidal activities for isoniazid and moxifloxacin were 0.209 and 0.273 log10 CFU p...

  13. Treatment outcomes in patients with multiple brain metastases: A prospective randomized study

    OpenAIRE

    Animesh Saha; Sajal Kumar Ghosh; Chhaya Roy; Priyanjit Kayal

    2014-01-01

    Context: There is controversy regarding the radiotherapeutic dose fractionation in brain metastases (bm). Aims: The aim of this study is to analyze the treatment outcomes in patients with multiple bm. Settings and Design: Prospective, randomized study. Subjects and Methods: Patients with multiple bm with Eastern Cooperative Oncology Group performance status ≤2 were included. In arm-A patient received whole brain radiotherapy (WBRT) 30 GY in 10# over 2 weeks and in arm-B patients received 20 G...

  14. Patient-matched instruments versus standard instrumentation in total knee arthroplasty: a prospective randomized study

    OpenAIRE

    Molicnik, Andrej; Naranda, Jakob; Dolinar, Drago

    2015-01-01

    Summary Background Optimal positioning of implants and restoration of neutral mechanical axis are two primary surgical goals in total knee arthroplasty (TKA). Despite modern instruments and improved surgical techniques, malalignment remains an important cause of early failure after TKA. The aim of this prospective randomized study was to compare the value of a new patient-matched instrument system (PMI) (SignatureTM; Biomet, Inc, Warsaw, Indiana) to that of standard TKA surgical instrumentati...

  15. COMPARATIVE EFFICACY OF MISOPROSTOL AND OXYTOCIN AS LABOR PREINDUCTION AGENTS: A PROSPECTIVE RANDOMIZED TRIAL

    OpenAIRE

    Zh. Abedi Asl; M. Farrokhi M. Rajaee

    2007-01-01

    The purpose of this study was to compare the efficacy and safety of misoprostol and oxytocin for induction of labor. In this prospective and randomized controlled trial one hundred twenty women with an unfavorable cervix who underwent labor induction were assigned to receive either intravenous high dose oxytocin(6mIu/min) or intravaginal misoprostol 50µg every 6 hours for two doses. Twelve hours later if labor was not stablished oxytocin induction was initiated per standardized prot...

  16. A prospective randomized comparison of sequential versus monoculture systems for in-vitro human blastocyst development

    OpenAIRE

    Macklon, Nick; Pieters, M.H.; Hassan, M. A.; Jeucken, P.H.; Eijkemans, René; Fauser, Bart

    2002-01-01

    textabstractBACKGROUND: Extending the period of in-vitro culture to the blastocyst stage may improve implantation rates in IVF treatment. Recognition of the dynamic nature of early embryo metabolism has led to the development of commercially available sequential culture systems. However, their improved efficacy over monoculture systems remains to be demonstrated in prospective studies. METHODS: Embryos obtained from 158 women undergoing IVF treatment were randomized by sealed envelopes to cul...

  17. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  18. Single-Blind, Prospective, Randomized Study of Cefmetazole and Cefoxitin in the Treatment of Postcesarean Endometritis

    OpenAIRE

    Ashwin Chatwani; Mark Martens; Grimes, David A; Molly Chatterjee; Melvin Noah; Stamp-Cole, Marion M.; Perry, Kimberly T.; the Cefmetazole Study Group

    1995-01-01

    Objective: The purpose of this study was to compare the clinical efficacy and safety of cefmetazole given by IV push with that of parenterally administered cefoxitin for the treatment of endometritis following cesarean delivery. Methods: In a single-blind, multicenter, prospective, randomized study, 355 patients with endometritis after cesarean delivery were enrolled and received medication. Administered was either cefmetazole sodium, 2 g by IV push over 1 min q 8 h, or cefoxitin sodium, 2 g ...

  19. Navigation of total knee arthroplasty: rotation of components and clinical results in a prospectively randomized study

    OpenAIRE

    Efe Turgay; Pfeiffer Michael; Kienapfel Heino; Hauk Carsten; Schmitt Jan; Fuchs-Winkelmann Susanne; Heyse Thomas J

    2011-01-01

    Abstract Background Navigation was introduced into total knee arthroplasty (TKA) to improve accuracy of component position, function and survival of implants. This study was designed to assess the outcome of navigated TKA in comparison with conventional implantation with the focus on rotational component position and clinical mid-term results. Methods In a prospectively randomized single-blinded approach, 90 patients with primary gonarthrosis were assigned to three different groups. Thirty pa...

  20. Prevention of osteoradionecrosis: a randomized prospective clinical trial of hyperbaric oxygen versus penicillin

    International Nuclear Information System (INIS)

    A prospective randomized trial comparing hyperbaric oxygen and systemic antibiotics in the prevention of osteoradionecrosis was presented. The results indicated, in a high-risk population who required tooth removal in irradiated mandibles, that up-front hyperbaric oxygen produced an incidence of osteoradionecrosis of 5.4% as compared with the antibiotic group of 29.9% (P = .005). Hyperbaric oxygen should be considered a prophylactic measure when post-irradiation dental care involving trauma to tissue is necessary

  1. Neoadjuvant chemotherapy with cisplatin and methotrexate in patients with muscle-invasive bladder tumours

    DEFF Research Database (Denmark)

    Sengeløv, Lisa; von der Maase, Hans; Lundbeck, Finn;

    2002-01-01

    This prospective, randomized study based on two associated trials was designed to evaluate the effect of neoadjuvant chemotherapy with cisplatin and methotrexate with folinic acid rescue or no chemotherapy prior to local treatment in patients with T2-T4b, NX-3, MO transitional cell carcinoma of t...... (actuarial rate). Neoadjuvant chemotherapy with cisplatin and methotrexate did not significantly improve disease-free or overall survival in 153 randomized patients with invasive bladder cancer.......This prospective, randomized study based on two associated trials was designed to evaluate the effect of neoadjuvant chemotherapy with cisplatin and methotrexate with folinic acid rescue or no chemotherapy prior to local treatment in patients with T2-T4b, NX-3, MO transitional cell carcinoma of the...

  2. Prospective multicenter study of combined treatment with chemotherapy and radiotherapy in breast cancer women with the rare clinical scenario of ipsilateral supraclavicular node recurrence without distant metastases

    International Nuclear Information System (INIS)

    Purpose: To evaluate the role of chemotherapy combined with curative radiotherapy in breast cancer patients who presented with recurrent ipsilateral supraclavicular lymph node metastases (ISLM) without 'nonregional disease,' we designed an observational study performed prospectively. Patients and Methods: Forty-four consecutive patients with ISLM from breast cancer as part of recurrent regional disease without distant metastases were included in this study. All patients received chemotherapy with doxorubicin-based schema or paclitaxel for six courses and curative radiotherapy (60 Gy/30 fractions of 2 Gy/5 days a week). An 'involved field' radiation was delivered during the interval between the third and fourth chemotherapy course; hormonal therapy was given based on receptor status. Results: The rate of overall clinical response after chemotherapy and radiotherapy was 94.9%. Median time to progression and overall survival were 28 and 40 months, respectively; the 5-year actuarial overall survival and disease-free survival rates were 35% (95% confidence interval, 19-51) and 20% (95% confidence interval, 6-34), respectively. Conclusion: A curative course of intravenous chemotherapy and radical irradiation is feasible in patients with ISLM. All patients presenting recurrence in supraclavicular nodes should be treated with definitive locoregional treatments and systemic therapy because the outcomes are better than might be historically assumed

  3. Effect of Remote Ischaemic Conditioning in Oncology Patients Undergoing Chemotherapy: Rationale and Design of the ERIC‐ONC Study—A Single‐Center, Blinded, Randomized Controlled Trial

    Science.gov (United States)

    Chung, Robin; Maulik, Angshuman; Hamarneh, Ashraf; Hochhauser, Daniel; Hausenloy, Derek J.; Walker, J. Malcolm

    2016-01-01

    ABSTRACT Cancer survival continues to improve, and thus cardiovascular consequences of chemotherapy are increasingly important determinants of long‐term morbidity and mortality. Conventional strategies to protect the heart from chemotherapy have important hemodynamic or myelosuppressive side effects. Remote ischemic conditioning (RIC) using intermittent limb ischemia‐reperfusion reduces myocardial injury in the setting of percutaneous coronary intervention. Anthracycline cardiotoxicity and ischemia‐reperfusion injury share common biochemical pathways in cardiomyocytes. The potential for RIC as a novel treatment to reduce subclinical myocyte injury in chemotherapy has never been explored and will be investigated in the Effect of Remote Ischaemic Conditioning in Oncology (ERIC‐ONC) trial (clinicaltrials.gov NCT 02471885). The ERIC‐ONC trial is a single‐center, blinded, randomized, sham‐controlled study. We aim to recruit 128 adult oncology patients undergoing anthracycline‐based chemotherapy treatment, randomized in a 1:1 ratio into 2 groups: (1) sham procedure or (2) RIC, comprising 4, 5‐minute cycles of upper arm blood pressure cuff inflations and deflations, immediately before each cycle of chemotherapy. The primary outcome measure, defining cardiac injury, will be high‐sensitivity troponin‐T over 6 cycles of chemotherapy and 12 months follow‐up. Secondary outcome measures will include clinical, electrical, structural, and biochemical endpoints comprising major adverse cardiovascular clinical events, incidence of cardiac arrhythmia over 14 days at cycle 5/6, echocardiographic ventricular function, N‐terminal pro‐brain natriuretic peptide levels at 3 months follow‐up, and changes in mitochondrial DNA, micro‐RNA, and proteomics after chemotherapy. The ERIC‐ONC trial will determine the efficacy of RIC as a novel, noninvasive, nonpharmacological, low‐cost cardioprotectant in cancer patients undergoing anthracycline

  4. Prospective Evaluation of Acute Toxicity and Quality of Life After IMRT and Concurrent Chemotherapy for Anal Canal and Perianal Cancer

    International Nuclear Information System (INIS)

    Purpose: A prospective cohort study was conducted to evaluate toxicity, quality of life (QOL), and clinical outcomes in patients treated with intensity modulated radiation therapy (IMRT) and concurrent chemotherapy for anal and perianal cancer. Methods and Materials: From June 2008 to November 2010, patients with anal or perianal cancer treated with IMRT were eligible. Radiation dose was 27 Gy in 15 fractions to 36 Gy in 20 fractions for elective targets and 45 Gy in 25 fractions to 63 Gy in 35 fractions for gross targets using standardized, institutional guidelines, with no planned treatment breaks. The chemotherapy regimen was 5-fluorouracil and mitomycin C. Toxicity was graded with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Correlations between dosimetric parameters and both physician-graded toxicities and patient-reported outcomes were evaluated by polyserial correlation. Results: Fifty-eight patients were enrolled. The median follow-up time was 34 months; the median age was 56 years; 52% of patients were female; and 19% were human immunodeficiency virus—positive. Stage I, II, III, and IV disease was found in 9%, 57%, 26%, and 9% of patients, respectively. Twenty-six patients (45%) required a treatment break because of acute toxicity, mainly dermatitis (23/26). Acute grade 3 + toxicities included skin 46%, hematologic 38%, gastrointestinal 9%, and genitourinary 0. The 2-year overall survival (OS), disease-free survival (DFS), colostomy-free survival (CFS), and cumulative locoregional failure (LRF) rates were 90%, 77%, 84%, and 16%, respectively. The global QOL/health status, skin, defecation, and pain scores were significantly worse at the end of treatment than at baseline, but they returned to baseline 3 months after treatment. Social functioning and appetite scores were

  5. Prospective Evaluation of Acute Toxicity and Quality of Life After IMRT and Concurrent Chemotherapy for Anal Canal and Perianal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kathy; Cummings, Bernard J.; Lindsay, Patricia; Skliarenko, Julia; Craig, Tim [Radiation Medicine Program, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Le, Lisa W. [Department of Biostatistics, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Brierley, James; Wong, Rebecca; Dinniwell, Robert; Bayley, Andrew J.; Dawson, Laura A.; Ringash, Jolie [Radiation Medicine Program, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Krzyzanowska, Monika K.; Moore, Malcolm J.; Chen, Eric X. [Department of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Easson, Alexandra M. [Department of Surgical Oncology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario (Canada); Kassam, Zahra; Cho, Charles [Radiation Medicine Program, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada); Kim, John, E-mail: John.Kim@rmp.uhn.on.ca [Radiation Medicine Program, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada)

    2014-11-01

    Purpose: A prospective cohort study was conducted to evaluate toxicity, quality of life (QOL), and clinical outcomes in patients treated with intensity modulated radiation therapy (IMRT) and concurrent chemotherapy for anal and perianal cancer. Methods and Materials: From June 2008 to November 2010, patients with anal or perianal cancer treated with IMRT were eligible. Radiation dose was 27 Gy in 15 fractions to 36 Gy in 20 fractions for elective targets and 45 Gy in 25 fractions to 63 Gy in 35 fractions for gross targets using standardized, institutional guidelines, with no planned treatment breaks. The chemotherapy regimen was 5-fluorouracil and mitomycin C. Toxicity was graded with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Correlations between dosimetric parameters and both physician-graded toxicities and patient-reported outcomes were evaluated by polyserial correlation. Results: Fifty-eight patients were enrolled. The median follow-up time was 34 months; the median age was 56 years; 52% of patients were female; and 19% were human immunodeficiency virus—positive. Stage I, II, III, and IV disease was found in 9%, 57%, 26%, and 9% of patients, respectively. Twenty-six patients (45%) required a treatment break because of acute toxicity, mainly dermatitis (23/26). Acute grade 3 + toxicities included skin 46%, hematologic 38%, gastrointestinal 9%, and genitourinary 0. The 2-year overall survival (OS), disease-free survival (DFS), colostomy-free survival (CFS), and cumulative locoregional failure (LRF) rates were 90%, 77%, 84%, and 16%, respectively. The global QOL/health status, skin, defecation, and pain scores were significantly worse at the end of treatment than at baseline, but they returned to baseline 3 months after treatment. Social functioning and appetite scores were

  6. Induction Chemotherapy and Continuous Hyperfractionated Accelerated Radiotherapy (CHART) for Patients With Locally Advanced Inoperable Non-Small-Cell Lung Cancer: The MRC INCH Randomized Trial

    International Nuclear Information System (INIS)

    Purpose: Recent clinical trials and meta-analyses have shown that both CHART (continuous hyperfractionated accelerated radiation therapy) and induction chemotherapy offer a survival advantage over conventional radical radiotherapy for patients with inoperable non-small cell-lung cancer (NSCLC). This multicenter randomized controlled trial (INCH) was set up to assess the value of giving induction chemotherapy before CHART. Methods and Materials: Patients with histologically confirmed, inoperable, Stage I-III NSCLC were randomized to induction chemotherapy (ICT) (three cycles of cisplatin-based chemotherapy followed by CHART) or CHART alone. Results: Forty-six patients were randomized (23 in each treatment arm) from 9 UK centers. As a result of poor accrual, the trial was closed in December 2007. Twenty-eight patients were male, 28 had squamous cell histology, 34 were Stage IIIA or IIIB, and all baseline characteristics were well balanced between the two treatment arms. Seventeen (74%) of the 23 ICT patients completed the three cycles of chemotherapy. All 42 (22 CHART + 20 ICT) patients who received CHART completed the prescribed treatment. Median survival was 17 months in the CHART arm and 25 months in the ICT arm (hazard ratio of 0.60 [95% CI 0.31-1.16], p = 0.127). Grade 3 or 4 adverse events (mainly fatigue, dysphagia, breathlessness, and anorexia) were reported for 13 (57%) CHART and 13 (65%) ICT patients. Conclusions: This small randomized trial indicates that ICT followed by CHART is feasible and well tolerated. Despite closing early because of poor accrual, and so failing to show clear evidence of a survival benefit for the additional chemotherapy, the results suggest that CHART, and ICT before CHART, remain important options for the treatment of inoperable NSCLC and deserve further study.

  7. Comparison of two purification products of shankha bhasma: A prospective randomized control trial

    Science.gov (United States)

    Ranade, Manjiri; Chary, Dingari Laxmana

    2013-01-01

    Background: Shankha bhasma is widely used in the treatment of gastroesophageal reflux disease (GERD) patients. Aim: To compare the efficacy of two purification methods of shankha bhasma in relieving GERD symptoms. In method A, purification was done with lemon juice and method B with sour gruel. Materials and Methods: Patients with heartburn since at least four days/week but who did undergo endoscopy to assess esophageal mucosa could participate. In this single-phase, single-center, prospective, randomized control trial, the patients were randomized to receive either shankha bhasma purified by method A or by method B. The primary efficacy variable was the proportion of patients with resolution of heartburn at week 4 and week 8. Design: Single-phase, single-center, prospective, randomized control trial in a hospital setting. Results: Of the total 70 patients who received samples A and B in a randomized double-blind manner, 65% of the patients showed resolution of symptoms in sample A and 28% in sample B at the end of four weeks, whereas, 71% of the patients showed resolution of symptoms in sample A and 31% in sample B at the end of eight weeks; P value was statistically significant for resolution of symptoms (P <0.005). Conclusion: Purification of shankha bhasma by lemon juice method is better than sour gruel method in terms of clinical outcome in GERD patients and is hence recommended. PMID:23633854

  8. Regional intra-arterial vs. systemic chemotherapy for advanced pancreatic cancer: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Fenghua Liu

    Full Text Available OBJECTIVE: To investigate the efficacy and safety of regional intra-arterial chemotherapy (RIAC versus systemic chemotherapy for stage III/IV pancreatic cancer. METHODS: Randomized controlled trials of patients with advanced pancreatic cancer treated by regional intra-arterial or systemic chemotherapy were identified using PubMed, ISI, EMBASE, Cochrane Library, Google, Chinese Scientific Journals Database (VIP, and China National Knowledge Infrastructure (CNKI electronic databases, for all publications dated between 1960 and December 31, 2010. Data was independently extracted by two reviewers. Odds ratios and relative risks were pooled using either fixed- or random-effects models, depending on I(2 statistic and Q test assessments of heterogeneity. Statistical analysis was performed using RevMan 5.0. RESULTS: Six randomized controlled trials comprised of 298 patients met the standards for inclusion in the meta-analysis, among 492 articles that were identified. Eight patients achieved complete remission (CR with regional intra-arterial chemotherapy (RIAC, whereas no patients achieved CR with systemic chemotherapy. Compared with systemic chemotherapy, patients receiving RIAC had superior partial remissions (RR = 1.99, 95% CI: 1.50, 2.65; 58.06% with RIAC and 29.37% with systemic treatment, clinical benefits (RR = 2.34, 95% CI: 1.84, 2.97; 78.06% with RAIC and 29.37% with systemic treatment, total complication rates (RR = 0.72, 95% CI: 0.60, 0.87; 49.03% with RIAC and 71.33% with systemic treatment, and hematological side effects (RR = 0.76, 95% CI: 0.63, 0.91; 60.87% with RIAC and 85.71% with systemic treatment. The median survival time with RIAC (5-21 months was longer than for systemic chemotherapy (2.7-14 months. Similarly, one year survival rates with RIAC (28.6%-41.2% were higher than with systemic chemotherapy (0%-12.9%.. CONCLUSION: Regional intra-arterial chemotherapy is more effective and has fewer complications than

  9. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial

    OpenAIRE

    Cella, D; Ivanescu, C; Holmstrom, S.; Bui, C. N.; Spalding, J.; Fizazi, K.

    2014-01-01

    Background To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial. Patients and methods Patients were randomly assigned to enzalutamide 160 mg/day or placebo. FACT-P was completed before randomization, at weeks 13, 17, 21, and 25, and every 12 weeks thereafter while on study tre...

  10. Randomized Phase 2 Trial of S1 and Oxaliplatin-Based Chemoradiotherapy With or Without Induction Chemotherapy for Esophageal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Dok Hyun [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Jang, Geundoo [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Department of Internal Medicine, Hallym Medical Center, Hallym University College of Medicine, Seoul (Korea, Republic of); Kim, Jong Hoon [Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Yong-Hee [Department of Thoracic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Ji Youn [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Hyeong Ryul [Department of Thoracic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Jung, Hwoon-Yong; Lee, Gin-Hyug [Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Song, Ho Young [Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Cho, Kyung-Ja [Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Ryu, Jin-Sook [Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Sung-Bae, E-mail: sbkim3@amc.seoul.kr [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of)

    2015-03-01

    Purpose: To assess, in a randomized, phase 2 trial, the efficacy and safety of chemoradiotherapy with or without induction chemotherapy (ICT) of S1 and oxaliplatin for esophageal cancer. Patients and Methods: Patients with stage II, III, or IVA esophageal cancer were randomly allocated to either 2 cycles of ICT (oxaliplatin 130 mg/m{sup 2} on day 1 and S1 at 40 mg/m{sup 2} twice daily on days 1-14, every 3 weeks) followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/d with oxaliplatin 130 mg/m{sup 2} on days 1 and 21 and S1 30 mg/m{sup 2} twice daily, 5 days per week during radiation therapy) and esophagectomy (arm A), or the same CCRT followed by esophagectomy without ICT (arm B). The primary endpoint was the pathologic complete response (pCR) rate. Results: A total of 97 patients were randomized (arm A/B, 47/50), 70 of whom underwent esophagectomy (arm A/B, 34/36). The intention-to-treat pCR rate was 23.4% (95% confidence interval [CI] 11.2-35.6%) in arm A and 38% (95% CI 24.5% to 51.5%) in arm B. With a median follow-up duration of 30.3 months, the 2-year progression-free survival rate was 58.4% in arm A and 58.6% in arm B, whereas the 2-year overall survival rate was 60.7% and 63.7%, respectively. Grade 3 or 4 thrombocytopenia during CCRT was more common in arm A than in arm B (35.4% vs 4.1%). The relative dose intensity of S1 (89.5% ± 20.6% vs 98.3% ± 5.2%, P=.005) and oxaliplatin (91.4% ± 16.8% vs 99.0% ± 4.2%, P=.007) during CCRT was lower in arm A compared with arm B. Three patients in arm A, compared with none in arm B, died within 90 days after surgery. Conclusions: Combination chemotherapy of S1 and oxaliplatin is an effective chemoradiotherapy regimen to treat esophageal cancer. However, we failed to show that the addition of ICT to the regimen can improve the pCR rate.

  11. Randomized Phase 2 Trial of S1 and Oxaliplatin-Based Chemoradiotherapy With or Without Induction Chemotherapy for Esophageal Cancer

    International Nuclear Information System (INIS)

    Purpose: To assess, in a randomized, phase 2 trial, the efficacy and safety of chemoradiotherapy with or without induction chemotherapy (ICT) of S1 and oxaliplatin for esophageal cancer. Patients and Methods: Patients with stage II, III, or IVA esophageal cancer were randomly allocated to either 2 cycles of ICT (oxaliplatin 130 mg/m2 on day 1 and S1 at 40 mg/m2 twice daily on days 1-14, every 3 weeks) followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/d with oxaliplatin 130 mg/m2 on days 1 and 21 and S1 30 mg/m2 twice daily, 5 days per week during radiation therapy) and esophagectomy (arm A), or the same CCRT followed by esophagectomy without ICT (arm B). The primary endpoint was the pathologic complete response (pCR) rate. Results: A total of 97 patients were randomized (arm A/B, 47/50), 70 of whom underwent esophagectomy (arm A/B, 34/36). The intention-to-treat pCR rate was 23.4% (95% confidence interval [CI] 11.2-35.6%) in arm A and 38% (95% CI 24.5% to 51.5%) in arm B. With a median follow-up duration of 30.3 months, the 2-year progression-free survival rate was 58.4% in arm A and 58.6% in arm B, whereas the 2-year overall survival rate was 60.7% and 63.7%, respectively. Grade 3 or 4 thrombocytopenia during CCRT was more common in arm A than in arm B (35.4% vs 4.1%). The relative dose intensity of S1 (89.5% ± 20.6% vs 98.3% ± 5.2%, P=.005) and oxaliplatin (91.4% ± 16.8% vs 99.0% ± 4.2%, P=.007) during CCRT was lower in arm A compared with arm B. Three patients in arm A, compared with none in arm B, died within 90 days after surgery. Conclusions: Combination chemotherapy of S1 and oxaliplatin is an effective chemoradiotherapy regimen to treat esophageal cancer. However, we failed to show that the addition of ICT to the regimen can improve the pCR rate

  12. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  13. Prospective Randomized Comparison of Open versus Transperitoneal Laparoscopic Ureterolithotomy: Experience of a Single Center from Northern India

    OpenAIRE

    Garg, Manish; Singh, Vishwajeet; Sinha, Rahul J.; Sankhwar, Satya N.; Kumar, Manoj; Kumar, Amit; Prakash, Jai; Kumar, Pradeep; Pandey, Mohit

    2013-01-01

    Aim Prospective randomized study on transperitoneal laparoscopic ureterolithotomy (TPLU) versus open ureterolithotomy (OU) for treatment of large impacted ureteric stones (≥ 1.5 cm) and assessment of overall results. Material & Methods In a prospective study between 2010 to 2012, 30 patients underwent TPLU and 30 OU based on 1:1 randomization. The operation was indicated primarily in 44 cases or after failed shock-wave lithotripsy/ureteroscopy in 16 cases. Two groups were compared for operati...

  14. Clinical efficacy of including capecitabine in neoadjuvant chemotherapy for breast cancer: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Qiuyun Li

    Full Text Available BACKGROUND: Capecitabine has proven effective as a chemotherapy for metastatic breast cancer. Though several Phase II/III studies of capecitabine as neoadjuvant chemotherapy have been conducted, the results still remain inconsistent. Therefore, we performed a meta-analysis to obtain more precise understanding of the role of capecitabine in neoadjuvant chemotherapy for breast cancer patients. METHODS: The electronic database PubMed and online abstracts from ASCO and SABCS were searched to identify randomized clinical trials comparing neoadjuvant chemotherapy with or without capecitabine in early/operable breast cancer patients without distant metastasis. Risk ratios were used to estimate the association between capecitabine in neoadjuvant chemotherapy and various efficacy outcomes. Fixed- or random-effect models were adopted to pool data in RevMan 5.1. RESULTS: Five studies were included in the meta-analysis. Neoadjuvant use of capecitabine with anthracycline and/or taxane based therapy was not associated with significant improvement in clinical outcomes including: pathologic complete response in breast (pCR; RR = 1.10, 95% CI 0.87-1.40, p = 0.43, pCR in breast tumor and nodes (tnpCR RR = 0.99, 95% CI 0.83-1.18, p = 0.90, overall response rate (ORR; RR = 1.00, 95% CI 0.94-1.07, p = 0.93, or breast-conserving surgery (BCS; RR = 0.98, 95% CI 0.93-1.04, p = 0.49. CONCLUSIONS: Neoadjuvant treatment of breast cancer involving capecitabine did not significantly improve pCR, tnpCR, BCS or ORR. Thus adding capecitabine to neoadjuvant chemotherapy regimes is unlikely to improve outcomes in breast cancer patients without distant metastasis. Further research is required to establish the condition that capecitabine may be useful in breast cancer neoadjuvant chemotherapy.

  15. Maintenance chemotherapy after chemoradiation improves survival of patients with locally advanced pancreatic carcinoma. A retrospective analysis of prospectively recruited patients

    International Nuclear Information System (INIS)

    Background and purpose: currently, there is no treatment standard for patients with locally advanced pancreatic cancer (PaCa) after chemoradiation. The aim of the present study was to retrospectively assess overall survival and toxicity of chemotherapy in addition to chemoradiation in this patient group. Patients and methods: three-dimensional conformal irradiation to the primary tumor (55.8 Gy) and the lymphatics (50.4 Gy) was combined with 5-fluorouracil- or gemcitabine-based chemotherapy followed by additional chemotherapy with gemcitabine until progression or no further treatment. Decision for chemotherapy was taken at the discretion of the attending physician considering the patient's desire. Results: a total of 172 patients were addressed to the local tumor board. Patients with (neo)adjuvant treatment or metastatic disease were excluded (n = 90). 82 patients were treated with chemoradiation and had additional chemotherapy (n = 40) or no further treatment (n = 42). Characteristics of the two groups were equally distributed. Patients with chemotherapy had significantly longer overall survival as compared to patients without (13 months vs. 8 months; p < 0.0001; median survival = 10.7 months for all patients). Acute toxicity of maintenance chemotherapy was relatively mild. Conclusion: maintenance chemotherapy after chemoradiation for patients with locally advanced PaCa may significantly increase survival rates without severe side effects and is therefore recommended as standard treatment following chemoradiation. (orig.)

  16. Invasive fungal infection in patients receiving chemotherapy for hematological malignancy: a multicenter, prospective, observational study in China.

    Science.gov (United States)

    Sun, Yuqian; Huang, He; Chen, Jing; Li, Jianyong; Ma, Jun; Li, Juan; Liang, Yingmin; Wang, Jianmin; Li, Yan; Yu, Kang; Hu, Jianda; Jin, Jie; Wang, Chun; Wu, Depei; Xiao, Yang; Huang, Xiaojun

    2015-02-01

    This stud y examined the epidemiology, risk factors, management, and outcome of invasive fungal infection (IFI) in patients receiving chemotherapy for hematological malignancy in China. IFI risk factors were analyzed using univariate analysis and multivariate logistic regression. In total, 4,192 patients receiving 4,889 chemotherapy courses were enrolled [mean age 40.7 years, 58.4% male, 16.9% children (NHL, 26.3%), and acute lymphoblastic leukemia (ALL, 20.2%). Severe neutropenia (absolute neutrophil count [ANC] <500/mm(3)) occurred after one third (1,633/4,889, 33.4%) of chemotherapy courses. Incidence of proven/probable IFI was 2.1% per chemotherapy course and higher in patients with myelodysplastic syndrome (MDS, 4.94%), acute hyperleukocytic leukemia (AHL, 4.76%), AML (3.83%), or induction chemotherapy. Risk factors included ANC <500/mm(3) [odds ratio (OR) 3.60], AML or MDS (OR 1.97), induction chemotherapy (OR 2.58), previous IFI (OR 3.08), and being male (OR 1.74). Antifungal agents, prescribed in one quarter (1,211/4,889, 24.8%) of chemotherapy courses, included primary/secondary prophylaxis (n = 827, 16.9%) and/or treatment (n = 655, 13.4%; 86.9 % triazoles), which was empirical (84.3%), pre-emptive (8.6%), or targeted (7.1%). Overall mortality following each chemotherapy course (1.5%) increased in proven/probable (11.7%) and possible IFI (8.2%). In summary, IFI was more common in MDS, AHL, AML, or induction chemotherapy, and substantially increased mortality. Neutropenic patients receiving induction chemotherapy for AML or MDS and those with previous IFI were at particular risk. Antifungal prophylaxis showed an independent protective effect but was not commonly used, even in high-risk patients. By contrast, empiric antifungals were widely used. PMID:25293517

  17. Use of Axillary Deodorant and Effect on Acute Skin Toxicity During Radiotherapy for Breast Cancer: A Prospective Randomized Noninferiority Trial

    International Nuclear Information System (INIS)

    Purpose: To prospectively determine the effect of deodorant use on acute skin toxicity and quality of life during breast radiotherapy (RT). Methods and Materials: Before breast RT, 84 patients were randomly assigned to the deodorant group (n = 40) or the no-deodorant group (n = 44). The patients were stratified by axillary RT and previous chemotherapy. Toxicity evaluations were always performed by the principal investigator, who was unaware of the group assignment, at the end of RT and 2 weeks after completion using the Radiation Therapy Oncology Group acute skin toxicity criteria. Symptoms of acute skin toxicity (i.e., discomfort, pain, pruritus, sweating) and quality of life were self-evaluated. For each criterion, the point estimate of rate difference with the 95% one-sided upper confidence limit was computed. To claim noninferiority owing to deodorant use, the 95% one-sided upper confidence limit had to be lower than the noninferiority margin, fixed to 12.8%. Results: In the deodorant vs. no-deodorant groups, Grade 2 axillary radiodermatitis occurred in 23% vs. 30%, respectively, satisfying the statistical criteria for noninferiority (p = .019). Grade 2 breast radiodermatitis occurred in 30% vs. 34% of the deodorant vs. no-deodorant groups, respectively, also satisfying the statistical criteria for noninferiority (p = .049). Similar results were observed for the self-reported evaluations. The deodorant group reported less sweating (18% vs. 39%, p = .032). No Grade 3 or 4 radiodermatitis was observed. Conclusion: According to our noninferiority margin definition, the occurrence of skin toxicity and its related symptoms were statistically equivalent in both groups. No evidence was found to prohibit deodorant use (notwithstanding the use of an antiperspirant with aluminum) during RT for breast cancer.

  18. A prospective study on concurrent chemotherapy and thoracic three-dimensional radiotherapy for stage IV non-small cell lung cancer (4)-The impact of response on survival

    International Nuclear Information System (INIS)

    Objective: To prospectively investigate the impact of short-time response on survival of concurrent chemotherapy and thoracic three-dimensional radiotherapy (CCTTRT) for stage IV non-small cell lung cancer (NSCLC). Methods: From Jan. 2003 to Oct. 2010, 201 patients with pathologically or cytologically proven stage IV NSCLC were included. All patients received platinum-based chemotherapy. Of the 167 patients eligible for analysis, the median number of chemotherapy were 4 cycles. The median dose for planning target volume (PTV) of thoracic primary tumor was 63 Gy. Response was scored according to WHO criteria. Survival was calculated by Kaplan-Meier method and compared using the Logrank. Cox regression model were used to examine the effect of response on overall survival. Results: The follow-up rate of 201 patients was 97.5%. with 201, 170 and 134 patients finished 2 =44.79, P =0.000). The MST for effective and ineffective group was 13.9 and 7.6 months, respectively in the whole group (χ2 =8.30, P =0.004), 12.1 months and 7.3 months in those treated with 2 - 3 cycles chemotherapy (χ2 =7.71, P =0.007), and 13.9 months and 7.9 months in those treated with 2 -5 cycles chemotherapy and radiation dose to PTV ≥36 Gy (χ2 =4.00, P =0.045). No significant MST difference was detected between patients of effective group and ineffective group treated with 4 -5 cycles chemotherapy (χ2 =0.67, P =0.413), or those treated with 4 -5 cycles of chemotherapy and radiation dose to primary lesion ≥36 Gy (χ2 =0.00, P =0.956). Multivariate analysis showed that 4-5 cycles of chemotherapy and CR and PR achieved in primary tumor (β =0.182, P=0.041) were independent favorable factors for survival. Conclusion: CCTTRT can improve local control, and prolong the survival time for Stage IV NSCLC. (authors)

  19. Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Four-Arm Randomized Trial on the Effectiveness of Electroacupuncture

    Directory of Open Access Journals (Sweden)

    M. Rostock

    2013-01-01

    Full Text Available Purpose. Chemotherapy-induced peripheral neuropathy (CIPN is a common and dose-limiting side effect of cytostatic drugs. Since there are no proven therapeutic procedures against CIPN, we were interested to define the role of electroacupuncture (EA from which preliminary data showed promising results. Methods. In a randomized trial with a group sequential adaptive design in patients with CIPN, we compared EA (LV3, SP9, GB41, GB34, LI4, LI11, SI3, and HT3; n=14 with hydroelectric baths (HB, n=14, vitamin B1/B6 capsules (300/300 mg daily; VitB, n=15, and placebo capsules (n=17. The statistical power in this trial was primarily calculated for proving EA only, so results of HB and VitB are pilot data. Results. CIPN complaints improved by 0.8±1.2 (EA, 1.7±1.7 (HB, 1.6±2.0 (VitB, and 1.3±1.3 points (placebo on a 10-point numeric rating scale without significant difference between treatment groups or placebo. In addition no significant differences in sensory nerve conduction studies or quality of life (EORTC QLQ-C30 were found. Conclusions. The used EA concept, HB, and VitB were not superior to placebo. Since, contrary to our results, studies with different acupuncture concepts showed a positive effect on CIPN, the effect of acupuncture on CIPN remains unclear. Further randomized, placebo controlled studies seem necessary. This trial is registered with DRKS00004448.

  20. Assessment of pulmonary toxicities in breast cancer patients undergoing treatment with anthracycline and taxane based chemotherapy and radiotherapy- a prospective study

    Directory of Open Access Journals (Sweden)

    Aramita Saha

    2013-12-01

    Full Text Available Background: Anthracycline based regiments and/or taxanes and adjuvant radiotherapy; the main modalities of treatment for breast cancers are associated with deterioration of pulmonary functions and progressive pulmonary toxicities. Aim: Assessment of pulmonary toxicities and impact on pulmonary functions mainly in terms of decline of forced vital capacity (FVC and the ratio of forced expiratory volume (FEV in 1 Second and FEV1/FVC ratio with different treatment times and follow ups in carcinoma breast patients receiving anthracycline and/or taxane based chemotherapy and radiotherapy. Materials and methods: A prospective single institutional cohort study was performed with 58 breast cancer patients between January 2011 to July 2012 who received either anthracycline based (37 patients received 6 cycles FAC= 5 FU, Adriamycin, Cyclophosphamide regime and radiotherapy or anthracycline and taxane based chemotherapy (21 patients received 4cycles AC= Adriamycin, Cyclophosphamide; followed by 4 cycles of T=Taxane and radiotherapy. Assessment of pulmonary symptoms and signs, chest x-ray and pulmonary function tests were performed at baseline, midcycle, at end of chemotherapy, at end radiotherapy, at 1 and 6 months follow ups and compared. By means of a two-way analysis of variance (ANOVA model, the course of lung parameters across the time points was compared. Results and Conclusion: Analysis of mean forced vital capacities at different points of study times showed definitive declining pattern, which is at statistically significant level at the end of 6th month of follow up (p=0.032 .The FEV1/FVC ratio (in percentage also revealed a definite decreasing pattern over different treatment times and at statistically significant level at 6th month follow up with p value 0.003. Separate analysis of mean FEV1/FVC ratios over time in anthracycline based chemotherapy and radiotherapy group as well as anthracycline and taxane based chemotherapy and radiotherapy group

  1. Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL: A prospective randomized HOVON trial

    OpenAIRE

    Vellenga, Edo; van Putten, Wim; Veer, Mars; Zijlstra, Josée; Fibbe, Willem; Oers, Marinus; Verdonck, Leo; Wijermans, Pierre; van Imhoff, Gustaaf; Lugtenburg, Pieternella; Huijgens, Peter

    2008-01-01

    textabstractWe evaluated the role of rituximab during remission induction chemotherapy in relapsed aggressive CD20+non-Hodgkin lymphoma. Of 239 patients, 225 were evaluable for analysis. Randomized to DHAP (cisplatin-cytarabine- dexamethasone)-VIM (etoposide-ifosfamide-methotrexate)-DHAP (cisplatin- cytarabine-dexamethasone) chemotherapy with rituximab (R; R-DHAP arm) were 119 patients (113 evaluable) and to chemotherapy without rituximab (DHAP arm) 120 patients (112 evaluable). Patients in c...

  2. Molecular analysis of anaplastic oligodendroglial tumors in a prospective randomized study: A report from EORTC study 26951.

    Science.gov (United States)

    Kouwenhoven, Mathilde C M; Gorlia, Thierry; Kros, Johan M; Ibdaih, Ahmed; Brandes, Alba A; Bromberg, Jacolien E C; Mokhtari, Karima; van Duinen, Sjoerd G; Teepen, Johannes L; Wesseling, Pieter; Vandenbos, Fanny; Grisold, Wolfgang; Sipos, László; Mirimanoff, Rene; Vecht, Charles J; Allgeier, Anouk; Lacombe, Denis; van den Bent, Martin J

    2009-12-01

    Recent studies have shown that the clinical outcome of anaplastic oligodendroglial tumors is variable, but also that the histological diagnosis is subject to interobserver variation. We investigated whether the assessment of 1p/19q codeletion, polysomy of chromosome 7, epidermal growth factor receptor (EGFR) gene amplification (EGFR(amp)), and loss of chromosome 10 or 10q offers additional prognostic information to the histological diagnosis and would allow molecular subtyping. For this study, we used the clinical data and tumor samples of the patients included in multicenter prospective phase III European Organisation for Research and Treatment of Cancer (EORTC) study 26951 on the effects of adjuvant procarbazine, chloroethyl cyclohexylnitrosourea (lomustine), and vincristine chemotherapy in anaplastic oligodendroglial tumors. Fluorescence in situ hybridization was used to assess copy number aberrations of chromosome 1p, 19q, 7, 10, and 10q and EGFR. Three different analyses were performed: on all included patients based on local pathology diagnosis, on the patients with confirmed anaplastic oligodendroglial tumors on central pathology review, and on this latter group but after excluding anaplastic oligoastrocytoma (AOA) with necrosis. As a reference set for glioblastoma multiforme (GBM), patients from the prospective randomized phase III study on GBM (EORTC 26981) were used as a benchmark. In 257 of 368 patients, central pathology review confirmed the presence of an anaplastic oligodendroglial tumor. Tumors with combined 1p and 19q loss (1p(loss)19q(loss)) were histopathologically diagnosed as anaplastic oligodendroglioma, were more frequently located in the frontal lobe, and had a better outcome. Anaplastic oligodendroglial tumors with EGFR(amp) were more frequently AOA, were more often localized outside the frontal lobe, and had a survival similar to that for GBM. Survival of patients with AOA harboring necrosis was in a similar range as for GBM, while patients

  3. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

    Directory of Open Access Journals (Sweden)

    Dinizio Anthony

    2008-01-01

    Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

  4. No major cognitive impairment in young children with acute lymphoblastic leukemia using chemotherapy only : A prospective longitudinal study

    NARCIS (Netherlands)

    Kingma, A; Van Dommelen, RI; Mooyaart, EL; Wilmink, JT; Deelman, BG; Kamps, WA

    2002-01-01

    Purpose: To study. using serial neuropsychological assessment and evaluation of school achievement, persistent neuropsychological late effects in children treated for acute lymphoblastic leukemia (ALL) at a young age with chemotherapy only. Patients and Methods: Twenty consecutive patients underwent

  5. Prognostic Role of BRAF Mutation in Stage II/III Colorectal Cancer Receiving Curative Resection and Adjuvant Chemotherapy: A Meta-Analysis Based on Randomized Clinical Trials

    Science.gov (United States)

    Cao, Ying; Fang, Xuefeng; Zhong, Chenhan; Li, Dan; Yuan, Ying

    2016-01-01

    Background and Objective Studies examining the prognostic value of the BRAF mutation on relapse-free survival (RFS), disease-free survival (DFS) and overall survival (OS) in stage II/III colorectal cancer (CRC) patients receiving curative resection and adjuvant chemotherapy so far showed discrepant results. Therefore, a meta-analysis of relevant studies was performed for clarification. Methods Randomized trials of stage II/III colorectal cancer treated with curative resection followed by adjuvant chemotherapy were selected to conduct a meta-analysis. The necessary descriptive and statistical information such as hazard ratios (HRs) and 95% confidence intervals (CIs) were derived from published survival data. Results Seven phase III randomized clinical trials (RCTs) including 1,035 BRAF mutation stage II/III CRC patients receiving curative resection and adjuvant chemotherapy were analyzed. Overall, BRAF mutation resulted in poorer OS (HR = 1.42, 95% CI: 1.25–1.60; P < 0.00001), and poorer DFS (HR = 1.26, 95% CI: 1.07–1.48, P = 0.006) compared with BRAF wild-type CRC. The prognostic role on RFS could not be elucidated in the meta-analysis because of limited data. Conclusions BRAF mutation was significantly related with shorter DFS and OS among stage II/III CRC patients receiving adjuvant chemotherapy after curative resection. Its prognostic role for RFS needs to be further analyzed when more data is available. PMID:27138801

  6. Impact of complementary mistletoe extract treatment on quality of life in breast, ovarian and non-small cell lung cancer patients. A prospective randomized controlled clinical trial.

    Science.gov (United States)

    Piao, B K; Wang, Y X; Xie, G R; Mansmann, U; Matthes, H; Beuth, J; Lin, H S

    2004-01-01

    Standardized aqueous mistletoe extracts have been applied to cancer patients for several decades as complementary medicine. A multicentric, randomized, open, prospective clinical trial was conducted in three oncological centers in the People's Republic of China in Bejing, Shenyang and Tianjin. Following the guidelines of "Good Clinical Practice" (GCP) this study was performed to get information on efficacy safety and side-effects of the standardized mistletoe extract (sME). Two hundred and thirty-three patients with breast (n=68), ovarian (n=71) and non-small cell lung cancer (NSCLC; n=94) were enrolled into this study. Two hundred and twenty-four patients fulfilled the requirements for final analysis (n=115 treated with sME HELIXOR A; n=109 comprising the control group being treated with the approved immunomodulating phytopharmacon Lentinan). All patients were provided with standard tumor-destructive treatment schedules and complementarily treated with sME or Lentinan during chemotherapy according to treatment protocol. Biometrically, the patients of the control and sME treatment group were comparable regarding distribution, clinical classification (WHO) and treatment protocols. Analysis was performed according to the "Intention to treat principle". Quality of life (QoL) was significantly (pcontrol group. Additionally, the occurrence of adverse events (AEs) was less frequent in the sME than in the control group (total number of AEs 52 versus 90 and number of serious AEs 5 versus 10 in study and control group, most of them due to chemotherapy). Only one serious AE was allocated to complementary treatment in each group (1 angioedema in sME group). All other side-effects of the sME (7 harmless local inflammatory reactions at subcutaneous injection site, 4 cases with fever) were self-limiting and did not demand therapeutic intervention. This study showed that complementary treatment with sME can beneficially reduce the side-effects of chemotherapy in cancer patients

  7. Comparative Efficacy of Cisplatin vs. Gemcitabine as Concurrent Chemotherapy for Untreated Locally Advanced Cervical Cancer: A Randomized Trail

    Directory of Open Access Journals (Sweden)

    Dr. Manoj Srivastava

    2007-01-01

    Full Text Available Cisplatin based chemo-radiation is considered the standard of care for most patients with locally advanced cervical cancer. Gemcitabine is a new pyrimidire analogue with high radio sensitizing potency in vitro. This study was undertaken to compare the anti-tumor activity and toxicity of the two drugs. It is a prospective randomized study of 60 patients histologically confirmed locally advanced cervical cancer, FIGO stage IIB - IIIB with no previous treatment. Patients were randomized to receive either weekly Cisplatin 40mg/m2 intravenously or Gemcitabine 100mg/m2 intravenously for 5 cycles concurrent with external beam radiation therapy 50Gy/25# as 5# / weeks, followed by single application of medium does rate intracavitory brachytherapy to deliver 20 Gy at point A, 2 weeks after completion of external beam radiation therapy (EBRT. Toxicity was graded according to WHO criteria. Both subjective and objective responses were measured six weeks after completion of treatment. In Cisplatin arm 28/30 (93.33% patients showed complete clinical regression of tumor whereas in Gemcitabine arm only 21/30 (70% patients showed complete clinical response. Thus immediate response was significantly higher in the cisplatin group as compared to the gemcitabine group (p=0.01. All toxicities except nausea and vomiting were more common and severe in patients receiving Gemcitabine with radiation. To conclude, Cisplatin appears to be better than Gemcitabine when used as a radio sensitizer for untreated locally advanced cervical cancer in terms of response and toxicity.

  8. The effect of induction chemotherapy followed by chemoradiotherapy in advanced head and neck cancer: a prospective study

    Directory of Open Access Journals (Sweden)

    Bhushan M. Nikam

    2014-04-01

    Conclusion: Response to induction chemotherapy was useful as predictive factor for ultimate outcome and progression free survival. But our study shows statistically significant improvement in complete response rate in group A as compared to group B (p<0.05. Our induction chemotherapy with two-drug regimen followed by concurrent chemoradiotherapy was well tolerated with manageable toxicity and good locoregional control. [Int J Res Med Sci 2014; 2(2.000: 476-480

  9. Role of p-glycoprotein expression in predicting response to neoadjuvant chemotherapy in breast cancer-a prospective clinical study

    OpenAIRE

    Bhatia Ashima; Bansal Anju; Saxena Sunita; Mittal Mahesh K; Singh Jai; Chintamani,; Kulshreshtha Pranjal

    2005-01-01

    Abstract Background Neoadjuvant chemotherapy (NACT) is an integral part of multi-modality approach in the management of locally advanced breast cancer. It is vital to predict response to chemotherapy in order to tailor the regime for a particular patient. The prediction would help in avoiding the toxicity induced by an ineffective chemotherapeutic regime in a non-responder and would also help in the planning of an alternate regime. Development of resistance to chemotherapeutic agents is a maj...

  10. Feasibility of breast conservation after neoadjuvant taxene based chemotherapy in locally advanced breast cancer: a Prospective Phase I trial

    Directory of Open Access Journals (Sweden)

    El-Sayed Mohamed I

    2010-08-01

    Full Text Available Abstract Background Neoadjuvant chemotherapy is the standard care for locally advanced breast cancer. Our study aimed at evaluating the feasibility of breast conversation surgery (BCS after neoadjuvant chemotherapy. Patients and methods Forty five patients had stage IIB (except those with T2N1 disease and stage IIIA were selected to 3 cycles taxane-based neoadjuvant chemotherapy. Patient who had tumours ≤5 cm underwent a tentative BCS while patients who had tumour size >5 cm underwent radical surgery. Negative margin is essential for BCS. Adjuvant chemotherapy and 3-D radiotherapy ± hormonal treatment were given to all patients. Results Thirty four patients had BCS. Response to chemotherapy was the only statistically significant factor which influences the BCS. Incidence of local recurrence was 5.9% for patients who had BCS at a median follow up 24 months. Conclusion Breast conservation is feasible in selected cases of locally advanced, non metastatic cancer breast. We recommend that patients who have tumour size ≤4 cm after chemotherapy are the best candidates for BCS.

  11. Is drug-induced toxicity a good predictor of response to neo-adjuvant chemotherapy in patients with breast cancer? -A prospective clinical study

    International Nuclear Information System (INIS)

    Neo-adjuvant chemotherapy is an integral part of multi-modality approach in the management of locally advanced breast cancer and it is vital to predict the response in order to tailor the regime for a patient. The common final pathway in the tumor cell death is believed to be apoptosis or programmed cell death and chemotherapeutic drugs like other DNA-damaging agents act on rapidly multiplying cells including both the tumor and the normal cells by following the same common final pathway. This could account for both the toxic effects and the response. Absence or decreased apoptosis has been found to be associated with chemo resistance. The change in expression of apoptotic markers (Bcl-2 and Bax proteins) brought about by various chemotherapeutic regimens is being used to identify drug resistance in the tumor cells. A prospective clinical study was conducted to assess whether chemotherapy induced toxic effects could serve as reliable predictors of apoptosis or response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. 50 cases of locally advanced breast cancer after complete routine and metastatic work up were subjected to trucut biopsy and the tissue evaluated immunohistochemically for apoptotic markers (bcl-2/bax ratio). Three cycles of Neoadjuvant Chemotherapy using FAC regime (5-fluorouracil, adriamycin, cyclophosphamide) were given at three weekly intervals and patients assessed for clinical response as well as toxicity after each cycle. Modified radical mastectomy was performed in all patients three weeks after the last cycle and the specimen were re-evaluated for any change in the bcl-2/bax ratio. The clinical response, immunohistochemical response and the drug-induced toxicity were correlated and compared. Descriptive studies were performed with SPSS version 10 and the significance of response was assessed using paired t-test. Significance of correlation between various variables was assessed using chi-square test and coefficient

  12. Is drug-induced toxicity a good predictor of response to neo-adjuvant chemotherapy in patients with breast cancer? -A prospective clinical study

    Directory of Open Access Journals (Sweden)

    Singh JP

    2004-08-01

    Full Text Available Abstract Background Neo-adjuvant chemotherapy is an integral part of multi-modality approach in the management of locally advanced breast cancer and it is vital to predict the response in order to tailor the regime for a patient. The common final pathway in the tumor cell death is believed to be apoptosis or programmed cell death and chemotherapeutic drugs like other DNA-damaging agents act on rapidly multiplying cells including both the tumor and the normal cells by following the same common final pathway. This could account for both the toxic effects and the response. Absence or decreased apoptosis has been found to be associated with chemo resistance. The change in expression of apoptotic markers (Bcl-2 and Bax proteins brought about by various chemotherapeutic regimens is being used to identify drug resistance in the tumor cells. A prospective clinical study was conducted to assess whether chemotherapy induced toxic effects could serve as reliable predictors of apoptosis or response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. Methods 50 cases of locally advanced breast cancer after complete routine and metastatic work up were subjected to trucut biopsy and the tissue evaluated immunohistochemically for apoptotic markers (bcl-2/bax ratio. Three cycles of Neoadjuvant Chemotherapy using FAC regime (5-fluorouracil, adriamycin, cyclophosphamide were given at three weekly intervals and patients assessed for clinical response as well as toxicity after each cycle. Modified radical mastectomy was performed in all patients three weeks after the last cycle and the specimen were re-evaluated for any change in the bcl-2/bax ratio. The clinical response, immunohistochemical response and the drug-induced toxicity were correlated and compared. Descriptive studies were performed with SPSS version 10 and the significance of response was assessed using paired t-test. Significance of correlation between various variables was

  13. [Prostate cancer and chemotherapy].

    Science.gov (United States)

    Gravis, Gwenaelle; Salem, Naji; Bladou, Franck; Viens, Patrice

    2007-07-01

    Androgen deprivation in patients with metastatic prostate cancer produces palliation of symptoms, PSA decrease and tumoral regression in most patients. After a brief period of disease regression lasting 18 to 24 months nearly all pts will progress to androgen independence disease (HRPC) with progressive clinical deterioration and ultimately death. Chemotherapy with mitoxantrone has been shown to palliate symptoms but did not extend survival. Two large randomized trials showed a survival benefit for pts with HRPC treated with docetaxel with a reduction risk of death by 21-24%, and significant improvement in palliation of symptoms and quality of life. New agents targeting angiogenesis, apoptosis, signal transduction pathway, used alone or in combination with docetaxel currently are under trial in an attempt to provide much needed improvements in outcome. Questions remains in suspend when and who need to be treated, earlier, in high risk as in adjuvant setting? Current data have demonstrated that neoadjuvant or adjuvant chemotherapy is relatively safe and feasible. Further investigation through prospective randomize trials is critical to define the precise role of this modality in high risk populations. PMID:17845990

  14. German-Austrian Glioma Study Phase III Randomized Multicenter Trial of Combined Radio- and Chemotherapy with BCNU or BCNU and VM26 in Malignant Supratentorial Glioma of Adults

    OpenAIRE

    Müller, Bettina

    2010-01-01

    Patients and methods: Malignant supratentorial glioma (anaplastic astrocytoma, oligoastrocytoma, oligodendroglioma and glioblastoma incl. gliosarcoma), age 16-70y, KPS 50-100. Postoperative randomization to chemotherapy with either BCNU (B) (80 mg/m2 x 3 every 6 weeks) alone or additional VM 26 (V) (50 mg/m2 x 3 every 6 weeks) starting concomitant with radiotherapy. Central histopathological review was required. Primary endpoints were survival time (ST) and progression free surviv...

  15. Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design

    OpenAIRE

    Moradian, S; Shahidsales, S; Nasiri, M.R.G; Pilling, M; Walshe, C; Molassiotis, A

    2015-01-01

    Purpose: Pharmacological therapy is only partially effective in preventing or treating chemotherapy induced nausea and vomiting (CINV). Therefore, exploring the complementary role of non-pharmacological approaches used in addition to pharmacological agents is important. Nevasic uses specially constructed audio signals hypothesized to generate an antiemetic reaction. The aim of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effective...

  16. Efficacy of the Additional Neoadjuvant Chemotherapy to Concurrent Chemoradiotherapy for Patients with Locoregionally Advanced Nasopharyngeal Carcinoma: a Bayesian Network Meta-analysis of Randomized Controlled Trials

    OpenAIRE

    Chen, Yu-Pei; Guo, Rui; Liu, Na; Liu, Xu; Mao, Yan-Ping; Tang, Ling-Long; Zhou, Guan-qun; Lin, Ai-Hua; Sun, Ying; Ma, Jun

    2015-01-01

    Background: Due to the lack of studies, it remains unclear whether the additional neoadjuvant chemotherapy (NACT) to concurrent chemoradiotherapy (CCRT) is superior to CCRT alone for locoregionally advanced nasopharyngeal carcinoma (NPC). The main objective of this Bayesian network meta-analysis was to determine the efficacy of NACT+CCRT as compared with CCRT alone. Methods: We comprehensively searched databases and extracted data from randomized controlled trials involving NPC patients who r...

  17. Individually tailored treatment with epirubicin and paclitaxel with or without capecitabine as first-line chemotherapy in metastatic breast cancer : a randomized multicenter trial

    OpenAIRE

    Hatschek, T.; Carlsson, L; Einbeigi, Z.; Lidbrink, E; Linderholm, B.; Lindh, Birgitta; Loman, N.; Malmberg, M.; Rotstein, S; Söderberg, M; Sundquist, M; Walz, TM; Hellström, M.; Svensson, H; Åström, G

    2012-01-01

    Anthracyclines and taxanes are active cytotoxic drugs in the treatment of early metastatic breast cancer. It is yet unclear whether addition of capecitabine to the combination of these drugs improves the treatment outcome. Patients with advanced breast cancer were randomized to first-line chemotherapy with a combination of epirubicin (Farmorubicin(A (R))) and paclitaxel (Taxol(A (R))) alone (ET) or in combination with capecitabine (Xeloda(A (R)), TEX). Starting doses for ET were epirubicin 75...

  18. Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies

    DEFF Research Database (Denmark)

    Skovsgaard, T.; Bork, E.; Damstrup, L.;

    2008-01-01

    BACKGROUND: The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer. METHODS: Patients with previously untreated GI cancer receiving...... bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC...... in Arm B (33%) than in A (13%, P< .01) and C (11%, P< .005). Duration was significantly longer in B than in both A (P= .035) and C (P= .003). CONCLUSIONS: The frequency and duration of OM are significantly improved by prophylactic chlorhexidine and by cryotherapy. The latter is easy and inexpensive...

  19. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study

    OpenAIRE

    Martínez Luis; Rodríguez Cindy M; Diaz-Romero Consuelo; Flores-Estrada Diana; Serna-Thomé Maria G; Villanueva-Rodríguez Geraldine; Michel Ortega Rosa M; Arrieta Oscar; Sánchez-Lara Karla

    2010-01-01

    Abstract Background A frequent manifestation of advanced NSCLC is malnutrition, even though there are many studies which relate it with a poor survival, its relation with toxicity has not yet been consistently reported. The aim of this study was to associate malnutrition and albumin serum levels with the occurrence of chemotherapy-induced toxicity in cisplatin plus paclitaxel chemotherapy-treated NSCLC. Methods We prospectively evaluated 100 stage IV NSCLC patients treated with paclitaxel (17...

  20. A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma

    OpenAIRE

    Amit Kumar Singh; Bhaskar Suryanarayanan; Ajay Choudhary; Akhila Prasad; Sachin Singh; Laxmi Narayan Gupta

    2014-01-01

    Objective: Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. Materials and Methods: A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, ...

  1. Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy

    International Nuclear Information System (INIS)

    Lipegfilgrastim is a novel glyco-pegylated granulocyte-colony stimulating factor in development for neutropenia prophylaxis in cancer patients receiving chemotherapy. This phase III, double-blind, randomized, active-controlled, noninferiority trial compared the efficacy and safety of lipegfilgrastim versus pegfilgrastim in chemotherapy-naïve breast cancer patients receiving doxorubicin/docetaxel chemotherapy. Patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5 × 109 cells/L were randomized to a single 6-mg subcutaneous injection of lipegfilgrastim (n = 101) or pegfilgrastim (n = 101) on day 2 of each 21-day chemotherapy cycle (4 cycles maximum). The primary efficacy endpoint was the duration of severe neutropenia during cycle 1. Cycle 1: The mean duration of severe neutropenia for the lipegfilgrastim and pegfilgrastim groups was 0.7 and 0.8 days, respectively (λ = −0.218 [95% confidence interval: –0.498%, 0.062%], p = 0.126), and no severe neutropenia was observed in 56% and 49% of patients in the lipegfilgrastim and pegfilgrastim groups, respectively. All cycles: In the efficacy population, febrile neutropenia occurred in three pegfilgrastim-treated patients (all in cycle 1) and zero lipegfilgrastim-treated patients. Drug-related adverse events in the safety population were reported in 28% and 26% of patients i006E the lipegfilgrastim and pegfilgrastim groups, respectively. This study demonstrates that lipegfilgrastim 6 mg is as effective as pegfilgrastim in reducing neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Eudra https://www.clinicaltrialsregister.eu/ctr-search/search?query The study protocol, two global amendments (Nos. 1 and 2), informed consent documents, and other appropriate study-related documents were reviewed and approved by the Ministry of Health of Ukraine Central Ethics Committee and local independent ethics committees (IECs)

  2. A randomized, double-blind, multicentre study comparing daily 2 and 5 mg of tropisetron for the control of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy

    NARCIS (Netherlands)

    Wymenga, ANM; vanderGraaf, WTA; Wils, JA; vanHeukelom, LS; vanderLinden, GHM; DullemondWestland, AC; Nooy, M; vanderHeul, C; deBruijn, KM; deVries, EGE

    1996-01-01

    Background: This study compares efficacy safety and tolerability of 2 and 5 mg tropisetron in prevention of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy. Patients and methods: 152 chemotherapy-naive cancer patients were randomized in a double-blind mann

  3. Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study)

    Science.gov (United States)

    Caira, Morena; Candoni, Anna; Verga, Luisa; Busca, Alessandro; Delia, Mario; Nosari, Annamaria; Caramatti, Cecilia; Castagnola, Carlo; Cattaneo, Chiara; Fanci, Rosa; Chierichini, Anna; Melillo, Lorella; Mitra, Maria Enza; Picardi, Marco; Potenza, Leonardo; Salutari, Prassede; Vianelli, Nicola; Facchini, Luca; Cesarini, Monica; De Paolis, Maria Rosaria; Di Blasi, Roberta; Farina, Francesca; Venditti, Adriano; Ferrari, Antonella; Garzia, Mariagrazia; Gasbarrino, Cristina; Invernizzi, Rosangela; Lessi, Federica; Manna, Annunziata; Martino, Bruno; Nadali, Gianpaolo; Offidani, Massimo; Paris, Laura; Pavone, Vincenzo; Rossi, Giuseppe; Spadea, Antonio; Specchia, Giorgina; Trecarichi, Enrico Maria; Vacca, Adriana; Cesaro, Simone; Perriello, Vincenzo; Aversa, Franco; Tumbarello, Mario; Pagano, Livio

    2015-01-01

    Correct definition of the level of risk of invasive fungal infections is the first step in improving the targeting of preventive strategies. We investigated the potential relationship between pre-hospitalization exposure to sources of fungi and the development of invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia after their first course of chemotherapy. From January 2010 to April 2012, all consecutive acute myeloid leukemia patients in 33 Italian centers were prospectively registered. Upon first admission, information about possible pre-chemotherapy risk factors and environmental exposure was collected. We recorded data regarding comorbid conditions, employment, hygienic habits, working and living environment, personal habits, hobbies, and pets. All invasive fungal infections occurring within 30 days after the first course of chemotherapy were recorded. Of the 1,192 patients enrolled in this study, 881 received intensive chemotherapy and were included in the present analysis. Of these, 214 developed an invasive fungal infection, including 77 proven/probable cases (8.7%). Of these 77 cases, 54 were proven/probable invasive mold infections (6.1%) and 23 were proven yeast infections (2.6%). Upon univariate analysis, a significant association was found between invasive mold infections and age, performance status, diabetes, chronic obstructive pulmonary disease, smoking, cocaine use, job, hobbies, and a recent house renovation. Higher body weight resulted in a reduced risk of invasive mold infections. Multivariate analysis confirmed the role of performance status, job, body weight, chronic obstructive pulmonary disease, and house renovation. In conclusion, several hospital-independent variables could potentially influence the onset of invasive mold infections in patients with acute myeloid leukemia. Investigation of these factors upon first admission may help to define a patient’s risk category and improve targeted prophylactic

  4. Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study).

    Science.gov (United States)

    Caira, Morena; Candoni, Anna; Verga, Luisa; Busca, Alessandro; Delia, Mario; Nosari, Annamaria; Caramatti, Cecilia; Castagnola, Carlo; Cattaneo, Chiara; Fanci, Rosa; Chierichini, Anna; Melillo, Lorella; Mitra, Maria Enza; Picardi, Marco; Potenza, Leonardo; Salutari, Prassede; Vianelli, Nicola; Facchini, Luca; Cesarini, Monica; De Paolis, Maria Rosaria; Di Blasi, Roberta; Farina, Francesca; Venditti, Adriano; Ferrari, Antonella; Garzia, Mariagrazia; Gasbarrino, Cristina; Invernizzi, Rosangela; Lessi, Federica; Manna, Annunziata; Martino, Bruno; Nadali, Gianpaolo; Offidani, Massimo; Paris, Laura; Pavone, Vincenzo; Rossi, Giuseppe; Spadea, Antonio; Specchia, Giorgina; Trecarichi, Enrico Maria; Vacca, Adriana; Cesaro, Simone; Perriello, Vincenzo; Aversa, Franco; Tumbarello, Mario; Pagano, Livio

    2015-02-01

    Correct definition of the level of risk of invasive fungal infections is the first step in improving the targeting of preventive strategies. We investigated the potential relationship between pre-hospitalization exposure to sources of fungi and the development of invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia after their first course of chemotherapy. From January 2010 to April 2012, all consecutive acute myeloid leukemia patients in 33 Italian centers were prospectively registered. Upon first admission, information about possible pre-chemotherapy risk factors and environmental exposure was collected. We recorded data regarding comorbid conditions, employment, hygienic habits, working and living environment, personal habits, hobbies, and pets. All invasive fungal infections occurring within 30 days after the first course of chemotherapy were recorded. Of the 1,192 patients enrolled in this study, 881 received intensive chemotherapy and were included in the present analysis. Of these, 214 developed an invasive fungal infection, including 77 proven/probable cases (8.7%). Of these 77 cases, 54 were proven/probable invasive mold infections (6.1%) and 23 were proven yeast infections (2.6%). Upon univariate analysis, a significant association was found between invasive mold infections and age, performance status, diabetes, chronic obstructive pulmonary disease, smoking, cocaine use, job, hobbies, and a recent house renovation. Higher body weight resulted in a reduced risk of invasive mold infections. Multivariate analysis confirmed the role of performance status, job, body weight, chronic obstructive pulmonary disease, and house renovation. In conclusion, several hospital-independent variables could potentially influence the onset of invasive mold infections in patients with acute myeloid leukemia. Investigation of these factors upon first admission may help to define a patient's risk category and improve targeted prophylactic

  5. High Incidences of Invasive Fungal Infections in Acute Myeloid Leukemia Patients Receiving Induction Chemotherapy without Systemic Antifungal Prophylaxis: A Prospective Observational Study in Taiwan.

    Directory of Open Access Journals (Sweden)

    Jih-Luh Tang

    Full Text Available Invasive fungal infections (IFIs is an important complication for acute myeloid leukemia (AML patients receiving induction chemotherapy. However, the epidemiological information is not clear in Southeastern Asia, an area of potential high incidences of IFIs. To clarify it, we enrolled 298 non-M3 adult AML patients receiving induction chemotherapy without systemic anti-fungal prophylaxis from Jan 2004 to Dec 2009, when we applied a prospective diagnostic and treatment algorithm for IFIs. Their demographic parameters, IFI characters, and treatment outcome were collected for analysis. The median age of these patients was 51 years. Standard induction chemotherapy was used for 246 (82.6% patients, and 66.8% of patients achieved complete remission (CR or partial remission. The incidence of all-category IFIs was 34.6% (5.7% proven IFIs, 5.0% probable IFIs and 23.8% possible IFIs. Candida tropicalis was the leading pathogen among yeast, and lower respiratory tract was the most common site for IFIs (75.4%, 80/106. Standard induction chemotherapy and failure to CR were identified as risk factors for IFIs. The presence of IFI in induction independently predicted worse survival (hazard ratio 1.536 (1.100-2.141, p value = 0.012. Even in those who survived from the initial IFI insults after 3 months, the presence of IFIs in induction still predicted a poor long-term survival. This study confirms high incidences of IFIs in Southeastern Asia, and illustrates potential risk factors; poor short-term and long-term outcomes are also demonstrated. This epidemiological information will provide useful perspectives for anti-fungal prophylaxis and treatment for AML patients during induction, so that best chances of cure and survival can be provided.

  6. High Incidences of Invasive Fungal Infections in Acute Myeloid Leukemia Patients Receiving Induction Chemotherapy without Systemic Antifungal Prophylaxis: A Prospective Observational Study in Taiwan

    Science.gov (United States)

    Kung, Hsiang-Chi; Yao, Ming; Wu, Un-In; Hsu, Szu-Chun; Lin, Chien-Ting; Li, Chi-Cheng; Wu, Shang-Ju; Hou, Hsin-An; Chou, Wen-Chien; Huang, Shang-Yi; Tsay, Woei; Chen, Yao-Chang; Chen, Yee-Chun; Chang, Shan-Chwen; Ko, Bor-Sheng; Tien, Hwei-Fang

    2015-01-01

    Invasive fungal infections (IFIs) is an important complication for acute myeloid leukemia (AML) patients receiving induction chemotherapy. However, the epidemiological information is not clear in Southeastern Asia, an area of potential high incidences of IFIs. To clarify it, we enrolled 298 non-M3 adult AML patients receiving induction chemotherapy without systemic anti-fungal prophylaxis from Jan 2004 to Dec 2009, when we applied a prospective diagnostic and treatment algorithm for IFIs. Their demographic parameters, IFI characters, and treatment outcome were collected for analysis. The median age of these patients was 51 years. Standard induction chemotherapy was used for 246 (82.6%) patients, and 66.8% of patients achieved complete remission (CR) or partial remission. The incidence of all-category IFIs was 34.6% (5.7% proven IFIs, 5.0% probable IFIs and 23.8% possible IFIs). Candida tropicalis was the leading pathogen among yeast, and lower respiratory tract was the most common site for IFIs (75.4%, 80/106). Standard induction chemotherapy and failure to CR were identified as risk factors for IFIs. The presence of IFI in induction independently predicted worse survival (hazard ratio 1.536 (1.100–2.141), p value = 0.012). Even in those who survived from the initial IFI insults after 3 months, the presence of IFIs in induction still predicted a poor long-term survival. This study confirms high incidences of IFIs in Southeastern Asia, and illustrates potential risk factors; poor short-term and long-term outcomes are also demonstrated. This epidemiological information will provide useful perspectives for anti-fungal prophylaxis and treatment for AML patients during induction, so that best chances of cure and survival can be provided. PMID:26061179

  7. Usefulness of concurrent chemotherapy and radiotherapy of head and neck cancer

    International Nuclear Information System (INIS)

    The usefulness of concurrent chemotherapy and radiotherapy in head and neck cancer was reviewed based on the results of randomized comparative trials. First, the schedules of chemotherapy and radiotherapy were assessed. Chemotherapy was classified into 4 categories according to the schedules: neo-adjuvant chemotherapy, concurrent chemotherapy, alternating chemotherapy, and adjuvant chemotherapy. Each schedules has its own purpose, e.g., tumor reduction, prevention of remote metastasis, and radiosensitizing effect. The most important purpose is the improvement of long-term outcome. Meta-analysis by Munro showed that the survival rate after neo-adjuvant chemotherapy was a mere 3.7%, as opposed to 12.1% for concurrent chemotherapy. Second, the results of 10 randomized comparative trials in the literature were reviewed. The radiation doses were 40-70 Gy. BLM, MTX, 5-FU, and MMC were administered in 7 trials, and 2 drugs, 5-FU and CDDP, and 5-FU and MMC, were combined in 3 trials. A statistically significant improvement in long-term outcome was only found in one study. In 7 studies it was reported that improvement of results is prospective, but further examination is necessary. Augmentation of the acute radiation effects by concurrent chemotherapy has been reported in many studies. A more adequate randomized comparative study should be carried out based on these findings. (K.H.)

  8. Herniography: A prospective, randomized study between midline and left iliac fossa puncture techniques

    International Nuclear Information System (INIS)

    AIM: To determine whether an optimal site of injection exists for herniography. MATERIALS AND METHODS: This was a prospective, randomized study of 93 consecutive patients who were referred for herniography over a period of 9 months. Patients underwent either a left iliac fossa (LIF) or midline puncture. Parameters assessed included initial adequate needle placement, complications, pain scores and body mass index (BMI). The groups were compared using Chi-squared test for categorical data, Student's t-test for continuous data and the Mann-WhitneyU-test for skewed data, withP 6 ml resulted in significantly more pain. More frequent initial adequate needle placement was observed in thin patients (BMI 2) with experienced operators. Conversely, increased body mass index resulted in more difficult needle placement. CONCLUSION: Herniography is a safe procedure with few complications. There was no significant difference comparing the midline and LIF approaches. Nadkarni, S. et al. (2001)

  9. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate

    DEFF Research Database (Denmark)

    Sønksen, Jens; Barber, Neil J; Speakman, Mark J; Berges, Richard; Wetterauer, Ulrich; Greene, Damien; Sievert, Karl-Dietrich; Chapple, Christopher R; Montorsi, Francesco; Patterson, Jacob M; Fahrenkrug, Lasse; Schoenthaler, Martin; Gratzke, Christian

    2015-01-01

    lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial...... safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. RESULTS AND LIMITATIONS: Preservation of ejaculation and quality of recovery were superior with PUL (p<0.01). Significant symptom relief was achieved in both treatment...... TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. PATIENT SUMMARY: In this study, participants who underwent prostatic urethral lift responded...

  10. Needle catheter jejunostomy: a controlled, prospective, randomized trial in patients with gynecologic malignancy.

    Science.gov (United States)

    Spirtos, N M; Ballon, S C

    1988-06-01

    Sixty patients with gynecologic cancer entered a prospective, randomized study of immediate postoperative feeding. Thirty-three women in the study group received an elemental diet (Vivonex HN) delivered through a needle catheter jejunostomy. Twenty-seven patients in the control group were given standard 5% dextrose and electrolyte solutions. Patients in both groups were stratified according to nutritional status as determined by anthropometric evaluation and levels of serum albumin, total protein, and transferrin. These parameters also were measured at intervals throughout the study. Only one catheter-related complication occurred. Patients in the study group received significantly more calories (p = 0.01) and were better able to maintain serum levels of transferrin (p = 0.05) than those in the control group. An elemental diet administered through the needle catheter jejunostomy effectively maintains postoperative nutrition and is associated with few complications. PMID:3132853

  11. A prospective randomized controlled trial of Wallace and Rocket embryo transfer catheters.

    Science.gov (United States)

    El-Shawarby, Salem A; Ravhon, Amir; Skull, Jonathan; Ellenbogen, Adrian; Trew, Geoffrey; Lavery, Stuart

    2008-10-01

    The aim of this study was to compare the efficacy of two embryo transfer catheters: Wallace and Rocket Embryon in an IVF programme of a tertiary referral university centre. A total of 308 patients undergoing embryo transfer were prospectively randomized to either a transfer with the Wallace catheter or a transfer with the Rocket catheter. The main outcome measure in this study was the clinical pregnancy rate, and secondary outcome measures included implantation rate, visibility of the catheter under ultrasound, number of retained embryos post transfer, and whether change of catheter was required. In addition, patient discomfort during the procedure was recorded. Pregnancy and implantation rates were similar when Wallace or Rocket catheters were used. However, for the Rocket catheter, the tip was more often clearly seen on ultrasound and it had a lower rate of retained embryos in the catheter after transfer (P < 0.05). Experience with different transfer catheters is recommended for difficult cases. PMID:18854110

  12. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  13. Design of the Resistance and Endurance exercise After ChemoTherapy (REACT study: A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue

    Directory of Open Access Journals (Sweden)

    van Mechelen Willem

    2010-11-01

    Full Text Available Abstract Background Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. Methods After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group. After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to. Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities. Measurements will be performed at baseline (t = 0, 12 weeks after randomization (t = 1, and 64 weeks after randomization (t = 2. The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance

  14. Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Launonen Antti P

    2012-09-01

    Full Text Available Abstract Background Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials. Methods/Design The study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH score and the secondary outcome measures will be the EuroQol-5D (EQ-5D value, OSS, Constant-Murley Score, VAS, and 15D. Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period. Discussion This publication

  15. OUTCOMES OF MANAGEMENT IN TALAR FRACTURES IN BHUBANESWAR, ODISHA : A RANDOMIZED PROSPECTIVE THERAPEUTIC STUDY

    Directory of Open Access Journals (Sweden)

    Sunil K.

    2015-01-01

    Full Text Available INTRODUCTION: Talar fractures are difficult and rare injuries with incidence of less than 2% 1 , are one of the most challenging and devastating injuries with varied prognosis, posing a real time challenge to orthopedic surgeons. METHODS: The study is a prospective multicenter randomized therapeutic study initiated in December ‘2006 on 40 patients with talus fracture to highlight and compare the different modalities of management of talar fractures in terms of functional and clinical results and complications. RESULTS: Out of 40 patients, 32 were male and 8 were female with a male/female ratio of 4:1. Most fractures were due to RTA in 22 cases. Most fractures were in neck of talus in 20 (50%. Out of 40 talar fractures, 10 were managed conservatively, 18 operated with screw fixation, 4 were fixed with cross K - wires and 8 old cases were managed with Blair’s fusion. We experienced complications in 12 cases. DISCUSSION: A high degree of suspicion is required for the diagnosis of talus/ talar processes fractures, talus being the second most common tarsal bone to fracture. The preferred surgical timing for talar neck fractures is controversial. But the scenario in the sub - continent is quite different wherein the patients report late to the hospital often due to ignorance, quack therapy and illiteracy, often presenting with complicated and neglected injuries. Also, published literature and long term prospective studies on talar fractures, its treatment and complications based on our population is lacking.

  16. A prospective, randomized, multi-center trial to investigate Actovegin in prevention and treatment of acute oral mucositis caused by chemoradiotherapy for nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Purpose: A multi-center prospective randomized trial was conducted to evaluate the efficacy and safety of Actovegin in the prevention and treatment of chemoradiotherapy-induced acute oral mucositis. Methods and materials: Between February 2006 and May 2007, 156 evaluable patients with nasopharyngeal carcinoma were randomized to Group 1 (n = 53) for prevention, Group 2 (n = 51) for treatment, and Group 3 (n = 52) for control. All patients received concomitant chemoradiotherapy ± induction chemotherapy. Radiation technique and dose were similar among 3 groups. Intravenous Actovegin of 30 ml daily (5 days/week) was administrated from day 1 of the radiotherapy for Group 1 and from the onset of grade 2 mucositis for Group 2, until the end of the radiotherapy. Results: The incidence of grade 3 mucositis was lower in Group 1 compared with Group 3 (26.4% vs. 55.8%, P = 0.002). Group 2 had a lower progression rate of mucositis from grade 2 to 3 compared with Group 3 (39.2% vs. 60.4%, P = 0.035). There was no difference in the onset time of grade 3 mucositis among 3 groups. Actovegin was well tolerated and no treatment-related adverse events were observed. Conclusions: Actovegin is effective in the prevention and treatment of chemoradiotherapy-induced oral mucositis.

  17. Neuropsychological Outcome of Children Treated for Standard Risk Medulloblastoma in the PNET4 European Randomized Controlled Trial of Hyperfractionated Versus Standard Radiation Therapy and Maintenance Chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Câmara-Costa, Hugo, E-mail: hugocamaracosta@gmail.com [National Institute of Health and Medical Research, INSERM U1178, Paris (France); Resch, Anika [University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Kieffer, Virginie [Saint Maurice Hospitals, Saint Maurice (France); Lalande, Clémence [Institut Gustave Roussy, Villejuif (France); Poggi, Geraldina [Scientific Institute, IRCCS Eugenio Medea, Bosisio Parini, Lecco (Italy); Kennedy, Colin; Bull, Kim [University of Southampton, Faculty of Medicine, Southampton (United Kingdom); Calaminus, Gabriele [Paediatric Oncology, University of Muenster, Muenster (Germany); Grill, Jacques [Institut Gustave Roussy, Villejuif (France); Doz, François [Institut Curie and University Paris Descartes, Sorbonne Paris Cité, Paris (France); Rutkowski, Stefan [University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Massimino, Maura [Fondazione IRCCS, Istituto Nazionale Tumori, Milan (Italy); Kortmann, Rolf-Dieter [Department of Radiation Therapy, University of Leipzig, Leipzig (Germany); Lannering, Birgitta [Paediatric Oncology, University of Gothenburg, Gothenburg (Sweden); Dellatolas, Georges [National Institute of Health and Medical Research, INSERM U1178, Paris (France); Chevignard, Mathilde [Rehabilitation Department for Children With Acquired Neurological Injury, Saint Maurice Hospitals, Saint Maurice, and Sorbonne Universités, UPMC Universités Paris, INSERM CNRS, Paris (France)

    2015-08-01

    Purpose: In the European HIT-SIOP PNET4 randomized controlled trial, children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy (HFRT arm, including a partially focused boost) or standard radiation therapy (STRT arm), followed, in both arms, by maintenance chemotherapy. Event-free survival was similar in both arms. Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function, especially in children <8 years of age at diagnosis. Therefore, the aim of this study was to compare performance-based cognitive outcomes between treatment arms. Methods and Materials: Neuropsychological data were collected prospectively in 137 patients. Using the Wechsler Intelligence Scales, Kaufman Assessment Battery for Children, and Raven's Progressive Matrices, we estimated full-scale intelligence quotient (FSIQ) and, when available, verbal IQ (VIQ), performance IQ (PIQ), working memory index (WMI), and processing speed index (PSI). Results: Among the 137 participants (HFRT arm n=71, STRT arm n=66, 63.5% males), mean (±SD) ages at diagnosis and assessment respectively were 9.3 (±3.2) years of age (40.8% < 8 years of age at diagnosis) and 14.6 (±4.3) years of age. Mean (±SD) FSIQ was 88 (±19), and mean intergroup difference was 3.88 (95% confidence interval: −2.66 to 10.42, P=.24). No significant differences were found in children >8 years of age at diagnosis. In children <8 years of age at diagnosis, a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm; a similar trend was found for PSI but not for PIQ, WMI, or FSIQ (mean intergroup differences were: 12.02 for VIQ [95% CI: 2.37-21.67; P=.02]; 3.77 for PIQ [95% CI: −5.19 to 12.74; P>.10]; 5.20 for WMI [95% CI: −2.07 to 12.47; P>.10]; 10.90 for PSI [95% CI: −1.54 to 23.36; P=.08]; and 5.28 for FSIQ [95% CI: −4.23 to 14.79; P>.10]). Conclusions: HFRT was associated with

  18. Neuropsychological Outcome of Children Treated for Standard Risk Medulloblastoma in the PNET4 European Randomized Controlled Trial of Hyperfractionated Versus Standard Radiation Therapy and Maintenance Chemotherapy

    International Nuclear Information System (INIS)

    Purpose: In the European HIT-SIOP PNET4 randomized controlled trial, children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy (HFRT arm, including a partially focused boost) or standard radiation therapy (STRT arm), followed, in both arms, by maintenance chemotherapy. Event-free survival was similar in both arms. Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function, especially in children <8 years of age at diagnosis. Therefore, the aim of this study was to compare performance-based cognitive outcomes between treatment arms. Methods and Materials: Neuropsychological data were collected prospectively in 137 patients. Using the Wechsler Intelligence Scales, Kaufman Assessment Battery for Children, and Raven's Progressive Matrices, we estimated full-scale intelligence quotient (FSIQ) and, when available, verbal IQ (VIQ), performance IQ (PIQ), working memory index (WMI), and processing speed index (PSI). Results: Among the 137 participants (HFRT arm n=71, STRT arm n=66, 63.5% males), mean (±SD) ages at diagnosis and assessment respectively were 9.3 (±3.2) years of age (40.8% < 8 years of age at diagnosis) and 14.6 (±4.3) years of age. Mean (±SD) FSIQ was 88 (±19), and mean intergroup difference was 3.88 (95% confidence interval: −2.66 to 10.42, P=.24). No significant differences were found in children >8 years of age at diagnosis. In children <8 years of age at diagnosis, a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm; a similar trend was found for PSI but not for PIQ, WMI, or FSIQ (mean intergroup differences were: 12.02 for VIQ [95% CI: 2.37-21.67; P=.02]; 3.77 for PIQ [95% CI: −5.19 to 12.74; P>.10]; 5.20 for WMI [95% CI: −2.07 to 12.47; P>.10]; 10.90 for PSI [95% CI: −1.54 to 23.36; P=.08]; and 5.28 for FSIQ [95% CI: −4.23 to 14.79; P>.10]). Conclusions: HFRT was associated with

  19. Prospective Pilot Study of Consolidation Chemotherapy With Docetaxel and Cisplatin After Concurrent Chemoradiotherapy for Advanced Head and Neck Cancer

    International Nuclear Information System (INIS)

    Purpose: With the improvement concurrent chemoradiotherapy (CCRT) in the management of patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC), distant failures have become a more relevant problem in terms of survival. The primary objective of this Phase II study is to assess the feasibility of docetaxel and cisplatin consolidation after primary CCRT for patients with HNSCC. Methods and Materials: Patients with locoregionally advanced HNSCC received chemotherapy with three cycles of cisplatin, 100 mg/m2, on Days 1, 22, and 43. Concurrent radiotherapy to the primary tumor and neck was given in a daily dose of 2 Gy to a total dose of 70-70.2 Gy over 7 weeks. After completion of CCRT, patients without evidence of disease progression received an additional four cycles of consolidation chemotherapy with docetaxel, 75 mg/m2, and cisplatin, 75 mg/m2, every 3 weeks. Results: Of 33 patients, 27 (81%) completed CCRT. After CCRT, three complete and 19 partial responses were recorded, giving an overall response rate of 67%. Of 19 patients who went to the consolidation phase, only 4 (21%) received all four cycles of docetaxel and cisplatin. Causes of failure of consolidation chemotherapy were toxicity in 11 patients, including three treatment-related deaths, and progression in 4 patients. Three patients died of sepsis during the consolidation phase. Median survival was 11 months for all patients and 8 months for those treated with consolidation chemotherapy. Conclusion: The poor compliance and high incidence of severe toxicities prompted no further evaluation of this consolidation chemotherapy after CCRT

  20. Effect of Agaricus sylvaticus supplementation on nutritional status and adverse events of chemotherapy of breast cancer: A randomized, placebo-controlled, double-blind clinical trial

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    Fabiana Valadares

    2013-01-01

    Full Text Available Background: Breast cancer (BC represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. Aim: To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. Materials and Methods: A randomized, placebo-controlled, double-blind, clinical trial was carried out at the Oncology Clinic, Hospital of the Federal District-Brazil from September 2007 to July 2009. Forty six patients with BC, Stage II and III, were randomly assigned to receive either nutritional supplement with A. sylvaticus (2.1 g/day or placebo. Patients were evaluated during treatment period. Results: Patient supplemented with A. sylvaticus improved in clinical parameters and gastrointestinal functions. Poor appetite decreased by 20% with no changes in bowel functions (92.8%, nausea and vomiting (80%. Conclusion: Dietary supplementation with A. sylvaticus improved nutritional status and reduced abnormal bowel functions, nausea, vomiting, and anorexia in patients with BC receiving chemotherapy.

  1. Chronic Obstructive Pulmonary Disease and Weaning of Difficult-to-wean Patients from Mechanical Ventilation: Randomized Prospective Study

    OpenAIRE

    Matić, Ivo; Đanić, Davorin; MAJERIĆ-KOGLER, VIŠNJA; Jurjević, Matija; Mirković, Ivan; Mrzljak Vučinić, Natalija

    2007-01-01

    Aim To compare T-tube and pressure support ventilation (PSV) as two methods of mechanical ventilation weaning of patients with chronic obstructive pulmonary disease (COPD) after failed extubation. Methods A prospective randomized trial carried out at the multidisciplinary intensive care unit (ICU) over 2 years included 136 patients with COPD who required mechanical ventilation longer than 24 h. The patients who could be weaned from mechanical ventilation were randomized to either a T-tube ...

  2. Pars plana vitrectomy versus three intravitreal injections of bevacizumab for nontractional diabetic macular edema. A prospective, randomized comparative study

    OpenAIRE

    Seemant Raizada; Jamal Al Kandari; Fahad Al Diab; Khalid Al Sabah; Niranjan Kumar,; Sebastian Mathew

    2015-01-01

    Background: The aim of this study was to compare the effectiveness of pars plana vitrectomy (PPV) and removal of the internal limiting membrane (ILM) with three, monthly, intravitreal bevacizumab (IVB) injections for refractory diabetic macular edema. Materials and Methods: This was a prospective, randomized, comparative, interventional study. Forty-four patients were enrolled and randomized in two groups. Twenty-two eyes enrolled in Group I received three IVB injections at monthly interval. ...

  3. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial

    OpenAIRE

    ISHIBASHI, KEIICHIRO; Ishida, Hideyuki; KUWABARA, KOUKI; OHSAWA, TOMONORI; OKADA, NORIMICHI; Yokoyama, Masaru; Kumamoto, Kensuke

    2013-01-01

    Purpose To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Methods Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of f...

  4. Influence of ultra-low dose Aprotinin on thoracic surgical operations: a prospective randomized trial

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    Sourgiadaki Efrosini

    2008-03-01

    Full Text Available Abstract Background The blood saving effect of aprotinin has been well documented in cardiac surgery. In thoracic surgery, very few recent studies, using rather high doses of aprotinin, have shown a similar result. In a randomized prospective trial, we have tested the influence of aprotinin using an ultra-low dose drug regime. Methods Fifty-nine patients, mean age 58 ± 13.25 years (mean ± SD undergoing general thoracic procedures were randomized into placebo (Group A and treatment group (Group B. The group B (n = 29 received 500.000 IU of aprotinin after induction to anesthesia and a repeat dose immediately after chest closure. A detailed protocol with several laboratory parameters was recorded. Patients were transfused when perioperative Ht was less than 26%. Results The two groups were similar in terms of age, gender, diagnosis, pathology, co-morbidity and operations performed. The mean drainage of the first and second postoperative day in group B was significantly reduced (412.6 ± 199.2 vs. 764.3 ± 213.9 ml, p Conclusion The perioperative ultra-low dose aprotinin administration was associated with a reduction of total blood losses and blood product requirements. We therefore consider the use of aprotinin safe and effective in major thoracic surgery.

  5. Complications of intravenous therapy: a randomized prospective study--Vialon vs. Teflon.

    Science.gov (United States)

    McKee, J M; Shell, J A; Warren, T A; Campbell, V P

    1989-01-01

    For the past two decades, the vast majority of vascular-access devices used in I.V. catheterization have been made of Teflon material. More recent developments in material science have produced the Vialon biomaterial currently used in the Insyte I.V. catheter. This prospective, randomized study compared the length of venous dwell time and rate of I.V.-related complications of Teflon peripheral I.V. catheters and Vialon peripheral I.V. catheters. The study population included only the most difficult peripheral I.V. access patients. Conditions of insertion, monitoring, and care were carefully controlled by the investigators. An alternate assignment scheme was used for randomization of eligible patients. Of 247 catheters evaluated over a six-week period in a 550-bed community tertiary care hospital, 191 were evaluable; of these, equivalent numbers were made of Vialon and Teflon. This investigation found that the incidence of phlebitis in the group receiving Vialon I.V. catheters was 36 percent lower than that of the group receiving Teflon I.V. catheters. PMID:2677289

  6. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  7. Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma.

    Science.gov (United States)

    Zhong, Lai-ping; Zhang, Chen-ping; Ren, Guo-xin; Guo, Wei; William, William N; Hong, Christopher S; Sun, Jian; Zhu, Han-guang; Tu, Wen-yong; Li, Jiang; Cai, Yi-li; Yin, Qiu-ming; Wang, Li-zhen; Wang, Zhong-he; Hu, Yong-jie; Ji, Tong; Yang, Wen-jun; Ye, Wei-min; Li, Jun; He, Yue; Wang, Yan-an; Xu, Li-qun; Zhuang, Zhengping; Lee, J Jack; Myers, Jeffrey N; Zhang, Zhi-yuan

    2015-07-30

    Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2/day 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy; in the control group, patients received upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Among 256 enrolled patients with a median follow-up of 70 months, estimated 5-year overall survival, disease-free survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 61.1%, 52.7%, 55.2%, and 60.4%, respectively. There were no significant differences in survival rates between experimental and control groups. However, patients with favorable pathologic responses had improved outcomes compared to those with unfavorable pathologic responses and to those in the control group. Although TPF induction chemotherapy did not improve long-term survival compared to surgery upfront in patients with stage III and IVA OSCC, a favorable pathologic response after induction chemotherapy may be used as a major endpoint and prognosticator in future studies. Furthermore, the negative results observed in this trial may be represent type II error from an underpowered study. Future larger scale phase III trials are warranted to investigate whether a significant benefit exists for TPF induction chemotherapy in surgically managed OSCC. PMID:26124084

  8. Randomized Trial of Postoperative Adjuvant Therapy in Stage II and III Rectal Cancer to Define the Optimal Sequence of Chemotherapy and Radiotherapy: 10-Year Follow-Up

    International Nuclear Information System (INIS)

    Purpose: To determine the optimal sequence of postoperative adjuvant chemotherapy and radiotherapy in patients with Stage II or III rectal cancer. Methods and Materials: A total of 308 patients were randomized to early (n = 155) or late (n = 153) radiotherapy (RT). Treatment included eight cycles of chemotherapy, consisting of fluorouracil 375 mg/m2/day and leucovorin 20 mg/m2/day, at 4-week intervals, and pelvic radiotherapy of 45 Gy in 25 fractions. Radiotherapy started on Day 1 of the first chemotherapy cycle in the early RT arm and on Day 1 of the third chemotherapy cycle in the late RT arm. Results: At a median follow-up of 121 months for surviving patients, disease-free survival (DFS) at 10 years was not statistically significantly different between the early and late RT arms (71% vs. 63%; p = 0.162). A total of 36 patients (26.7%) in the early RT arm and 49 (35.3%) in the late RT arm experienced recurrence (p = 0.151). Overall survival did not differ significantly between the two treatment groups. However, in patients who underwent abdominoperineal resection, the DFS rate at 10 years was significantly greater in the early RT arm than in the late RT arm (63% vs. 40%; p = 0.043). Conclusions: After the long-term follow-up duration, this study failed to show a statistically significant DFS advantage for early radiotherapy with concurrent chemotherapy after resection of Stage II and III rectal cancer. Our results, however, suggest that if neoadjuvant chemoradiation is not given before surgery, then early postoperative chemoradiation should be considered for patients requiring an abdominoperineal resection.

  9. The preliminary result of a prospective study of bladder conserving treatment using transurethral resection, transarterial chemotherapy and local involved field radiotherapy in invasive bladder cancer

    Energy Technology Data Exchange (ETDEWEB)

    Nagano, Hisato; Nagata, Maki; Yamaguchi, Yoshio; Nagashima, Toshiyuki; Tanohata, Kazunori [Yokohama Rosai Hospital (Japan)

    2002-12-01

    Radical cystectomy has been a standard treatment for invasive urinary bladder cancer, however preservation therapy is being considered in many facilities as a clinical examination. After transurethral resection of the bladder (TUR-Bt), three-time transarterial infusion (TAI) of cisplatin (CDDP) 45 mg/m{sup 2}, methotrexate (MTX) 30 mg/m{sup 2} and local five-port external beam radiation therapy (EBRT) of 60 Gy/30 fx/ 6 wks were delivered concurrently. Because such reports of organ sparing treatment using TAI are few, a mono-arm prospective study was designed to evaluate the rate of complete response (CR) (Response Evaluation Criteria In Solid Tumor (RECIST) standard) and the incidence of acute toxicity (National Cancer Institute (NCI) standard) compared with previous reports in which intravenous chemotherapy was used in a tri-modality treatment protocol. Twenty-three patients with T{sub 2-4}N{sub 0}M{sub 0} or High risk T{sub 1}N{sub 0}M{sub 0} were registered (T{sub 1}; 7, T{sub 2}; 7, T{sub 3}; 8, T{sub 4}; 1). They were all in good performance status (PS) (0-1). CR rate after intravesical therapy with bacilli Calmette-Guerin (BCG) was eighty-seven percent (confidence interval (CI) 66-97%). There was a significant difference (p=0.03) between this value and that (CR rate=62%, n=299) calculated from two reports in which transvenous chemotherapy was used as one of the treatment modalities. Grade three white blood cell decrease was seen in twenty-six percent of patients. This was significantly higher than the value estimated from reports using cisplatin only as the single chemotherapy agent. An acute reaction of the urinary bladder and rectum was negligible. After fifteen-month follow-up, four patients relapsed and two showed metastatic lesions. According to the protocol, three of the former four had already received cystectomy, but one had undergone an intra-vesicle BCG injection because it showed non-invasive papillary histology, and reached CR again. M

  10. Single-blinded prospective randomized study comparing open versus needle technique for obtaining autologous cancellous bone from the iliac crest.

    NARCIS (Netherlands)

    Bartels, R.H.M.A.

    2005-01-01

    One of the most frequent complications of cervical anterior discectomy with fusion is pain at the donor site, usually the iliac crest. Despite the advent of new materials, autologous bone is still the "gold standard" for fusion procedures. A prospective, single blinded, randomized study was performe

  11. Oral bacterial community dynamics in paediatric patients with malignancies in relation to chemotherapy-related oral mucositis: a prospective study

    OpenAIRE

    Ye, Y; Carlsson, G; Agholme, M Barr; Wilson, J A L; Roos, A.; Henriques-Normark, B.; Engstrand, L; Modéer, T.; Pütsep, K; D. Raoult

    2013-01-01

    The role of oral bacteria in the development of chemotherapy-related oral mucositis has not been fully elucidated. This study aimed to investigate oral bacterial community diversity and dynamics in paediatric patients with malignancies in relation to the occurrence of oral mucositis. Patients with malignancies (n = 37) and reference individuals without known systemic disorders (n = 38) were recruited. For patients, oral bacterial samples were taken from mucosal surfaces both at the time of ma...

  12. Evaluation of chemotherapy response with serum squamous cell carcinoma antigen level in cervical cancer patients: a prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Mingzhu Yin

    Full Text Available MRI does not always reflect tumor response after chemotherapy. Therefore, it is necessary to explore additional parameters to more accurately evaluate tumor response for the subsequent clinical determination about radiotherapy or radical surgery. A training cohort and an external validation cohort were used to examine the predictive performance of SCC-ag to evaluate tumor response from teaching hospital of Harbin Medical University. The study included 397 women with SCC (age: 28-73 years. Patients consecutively enrolled between August 2008 and January 2010 (n = 205 were used as training cohort. Patients consecutively enrolled between February 2010 and May 2011 (n = 192 were used as validation cohort. A multivariate regression analysis of the data from the training cohort indicated that serum SCC-ag level is an independent factor for neo-adjuvant chemotherapy (NACT response. Analysis of the data from the validation cohort suggested that chemotherapy response could be more accurately predicted by SCC-ag than by magnetic resonance imaging (MRI (sensitivity (Se: 0.944 vs. 0.794; specificity (Sp: 0.727 vs. 0.636; positive predictive value (PPV: 0.869 vs. 0.806; negative predictive value (NPV: 0.873 vs. 0.618; the area under ROC curve (AUC: 0.898 vs. 0.734. Combining SCC-ag with MRI was more powerful than MRI alone (Se: 0.952 vs. 0.794; Sp: 0.833 vs. 0.636; PPV: 0.916 vs. 0.806; NPV: 0.902 vs. 0.618; AUC: 0.950 vs. 0.734. Our study indicates that serum SCC-ag level is a sensitive and reliable measure to evaluate cervical cancer response to chemotherapy. Using SCC-ag in combination with MRI findings further improves the predictive power.

  13. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  14. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure

    Directory of Open Access Journals (Sweden)

    Tojo Katsuyoshi

    2008-05-01

    Full Text Available Abstract Background The large clinical trials proved that Basal-Bolus (BB insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. Methods In PROBE (Prospective, Randomized, Open, Blinded-Endpoint design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range age: 64.5(56.8~71.0years with secondary failure of sulfonylurea (SU were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group, and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. Results After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3 → 7.4(6.9~8.7%, p Conclusion Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. Trial registration Current Controlled Trials number, NCT00348231

  15. Prospective, double blind, randomized, controlled trial of simvastatin in human fracture healing.

    Science.gov (United States)

    Patil, Sanjeev; Holt, Graeme; Raby, Nigel; McLellan, Alastair R; Smith, Karen; O'Kane, Sarah; Beastall, Graham; Crossan, James F

    2009-03-01

    Although statins are widely prescribed as cholesterol-lowering drugs, a number of studies suggest that these compounds may have anabolic effects on bone. Our aim was to assess whether simvastatin affects the rate of fracture healing in humans. A prospective, double-blind, randomized controlled trial was performed. Individuals who had sustained an undisplaced, extra-articular fracture of the distal radial metaphysis were recruited from a trauma clinic. Patients were randomized to receive simvastatin 20 mg once daily or a placebo. Regular clinical and radiological follow-up was undertaken for a 12 week period. Dual-energy X-ray absorptiometry assessment of bone mineral density was conducted at 2 and 12 weeks postinjury. Biochemical markers of bone turnover were assayed during the study period. Time to fracture union was defined as the time to cortical bridging in four cortices on plain radiographs. In addition, the rate of trabecular union was assessed. Eighty patients were recruited, of which 62 completed the study (31 in each group). Study cohorts were matched for age and gender. For patients receiving simvastatin therapy, the mean time to fracture union was 71.6 days (SD 22.2 days, SEM 3.8 days). This compared to 71.3 days (SD 21.3, SEM 4.1 days) for the control cohort (p = 0.6481). There was no significant difference between bone mineral density or bone biochemical markers between groups (p > 0.05). Despite promising results from in vivo and in vitro animal studies, simvastatin at a treatment dose of 20 mg once daily does not affect the rate of fracture healing in humans. PMID:18853428

  16. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    Science.gov (United States)

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  17. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Evandro Pereira Palacio

    2016-02-01

    Full Text Available ABSTRACT OBJECTIVE: To evaluate the effects of platelet-rich plasma (PRP infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH and Patient-Rated Tennis Elbow Evaluation (PRTEE questionnaires. METHODS: Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. RESULTS: Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62. There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. CONCLUSION: At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires.

  18. Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Łukasz Szarpak

    2014-04-01

    Full Text Available Background: Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological material. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. Materials and Methods: In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. Results: The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. Conclusions: The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery. Med Pr 2014;65(2:271–278

  19. COMPARATIVE EFFICACY OF MISOPROSTOL AND OXYTOCIN AS LABOR PREINDUCTION AGENTS: A PROSPECTIVE RANDOMIZED TRIAL

    Directory of Open Access Journals (Sweden)

    Zh. Abedi Asl

    2007-09-01

    Full Text Available The purpose of this study was to compare the efficacy and safety of misoprostol and oxytocin for induction of labor. In this prospective and randomized controlled trial one hundred twenty women with an unfavorable cervix who underwent labor induction were assigned to receive either intravenous high dose oxytocin(6mIu/min or intravaginal misoprostol 50µg every 6 hours for two doses. Twelve hours later if labor was not stablished oxytocin induction was initiated per standardized protocol (3mIu/min. Mean Bishop Score change (± SD over the initial 12 hours interval was significantly greater in the misoprostol group (11.98± 1.55 compared with the oxytocin group (8.83 ± 2.61. There were no statistically significant differences in the median duration of labor ( 449±261.1 min, 514.5±288.5 min, respectively;p=0.22 , the mode of delivery or the adverse maternal /neonatal out come among the two groups.Use of misoprostol as a labor preinduction / labor induction agent results in greater Bishop score changes compared with high dose oxytocin and both of them are comparable.

  20. Lornoxicam versus diclofenac sodium in acute renal colic: a prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Sushila Godara

    2013-04-01

    Full Text Available Background: Acute renal colic is excruciatingly painful event, opioid analgesics and nonsteroidal anti-inflammatory drugs remain the mainstay of treatment for acute renal colic. This study compares diclofenac and lornoxicam in their efficacy to relieve pain of renal origin. Methods: Prospective, randomized, double blind clinical study including eighty patients with renal pain admitted in emergency department of a tertiary care teaching hospital. Parameters were observed at baseline and after 15, 30, 60, 180 minutes and 5hrs of drug treatment. The efficacy of the drug was measured by observing: Pain score, onset & duration of action, rescue drug use, global patient and physician impression. Results: Both drugs are effective in relieving pain of renal origin (p<0.05 and maintaining it over time as well. When decrease in value of pain score compared between two groups at various interval there was statistically significant (p<0.05 decrease in pain score only at 15 minutes in lornoxicam group showing this slightly more effective in early phase compared to diclofenac. In either group there is no statistically significant difference regarding onset of action, duration of action and side effect profile. Conclusions: Both the drugs are equally effective and safe in renal colicky pain with added advantage of lornoxicam being more effective in early period. [Int J Basic Clin Pharmacol 2013; 2(2.000: 193-198

  1. Frequency format diagram and probability chart for breast cancer risk communication: a prospective, randomized trial

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    Wahner-Roedler Dietlind

    2008-10-01

    Full Text Available Abstract Background Breast cancer risk education enables women make informed decisions regarding their options for screening and risk reduction. We aimed to determine whether patient education regarding breast cancer risk using a bar graph, with or without a frequency format diagram, improved the accuracy of risk perception. Methods We conducted a prospective, randomized trial among women at increased risk for breast cancer. The main outcome measurement was patients' estimation of their breast cancer risk before and after education with a bar graph (BG group or bar graph plus a frequency format diagram (BG+FF group, which was assessed by previsit and postvisit questionnaires. Results Of 150 women in the study, 74 were assigned to the BG group and 76 to the BG+FF group. Overall, 72% of women overestimated their risk of breast cancer. The improvement in accuracy of risk perception from the previsit to the postvisit questionnaire (BG group, 19% to 61%; BG+FF group, 13% to 67% was not significantly different between the 2 groups (P = .10. Among women who inaccurately perceived very high risk (≥ 50% risk, inaccurate risk perception decreased significantly in the BG+FF group (22% to 3% compared with the BG group (28% to 19% (P = .004. Conclusion Breast cancer risk communication using a bar graph plus a frequency format diagram can improve the short-term accuracy of risk perception among women perceiving inaccurately high risk.

  2. Total costs of laparoscopic and lichtenstein inguinal hernia repairs: a randomized prospective study.

    Science.gov (United States)

    Heikkinen, T; Haukipuro, K; Leppälä, J; Hulkko, A

    1997-02-01

    In a prospective, randomized study, laparoscopic (n = 20) and Lichtenstein (n = 18) inguinal hernia repairs were compared in relation to operative time, operative costs, hospital stay, postoperative pain, return to work, patient satisfaction, complications, and total costs. All the operations were performed with the patient under general anesthesia. The median operative times in the laparoscopic and Lichtenstein groups were 71.5 (range, 43-140) and 45 (16-83) min, respectively (p < 0.001). Postoperative pain and use of analgesics was less in the laparoscopic group. The median time to return to work was 14 (8-26) days in the laparoscopic group and 19 (5-40) days in the Lichtenstein group. More complications occurred in the Lichtenstein group. The median of the operative costs, in U.S. dollars, was $1,395 and $878, respectively, and the median total costs (including community expenses resulting from lost workdays) were $4,796 in the laparoscopic and $5,320 in the Lichtenstein groups. PMID:9116938

  3. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial☆

    Science.gov (United States)

    Palacio, Evandro Pereira; Schiavetti, Rafael Ramos; Kanematsu, Maiara; Ikeda, Tiago Moreno; Mizobuchi, Roberto Ryuiti; Galbiatti, José Antônio

    2016-01-01

    Objective To evaluate the effects of platelet-rich plasma (PRP) infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH) and Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaires. Methods Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. Results Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62). There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. Conclusion At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires. PMID:26962506

  4. A prospective study on concurrent chemotherapy and thoracic three - dimensional radiotherapy for stage IV non - small cell lung cancer (2) - The impact of different metastasis organs on survival

    International Nuclear Information System (INIS)

    Objective: To prospectively evaluate the survival of different metastasis organs with concurrent chemotherapy and thoracic three-dimensional radiotherapy (CCTTRT) for stage IV non-small cell lung cancer (NSCLC). Methods: Two hundred and one patients of stage IV NSCLC were enrolled from January, 2003 to July, 2010. Of the 182 patients eligible for analysis, The number of patients with single-organ metastasis or multiple-organ metastasis was 107 and 75, respectively. Patients were treated by platinum-based chemotherapy, the median number of cycle was 4. The median dose to planning target volume of primary tumor (DTPTV) was 63 Gy. Survival was calculated by Kaplan-Meier method and compared using the Logrank. Results: The follow-up rate of 201 patients was 97.5%. with 201, 170 and 134 patients finished 2 =10.10, P =0.001), respectively; compared with multi-organ metastasis, the 1-, 2-, and 3-year OS rate and MST of patients with bone, lung metastasis only was 58%, 25%, 16% and 14 months (χ2 =10.42, P=0.001) and 49%, 21%, 21% and 11 months (χ2 =6.39, P=0.011) respectively;patients with brain metastasis only did not show advantage of survival comparing with patients with multi-organ metastasis (49%, 8%, 0% and 12 months and 29%, 12%, 0% and 8 months,respectively; χ2 =0.71, P =0.401); the 1-, 2-, and 3-year OS rate and MST was 63%, 23%, 19% and 15 months and 42%, 15%, 0% and 10 months,respectively for patients with single-organ metastasis and multi-organ metastasis patients who accepted 4 - 5 cycles of chemotherapy (χ2 =6.47, P =0.011); for patients under the same metastasis and 4 - 5 cycles of chemotherapy, no matter whether single-organ or multiple-organ metastases, the 1 -, 2-, 3-year OS rate and MST of patients with enough radiotherapy on DTPTV ≥63 Gy were better than patients without enough radiotherapy (DTPTV 2 =4.73, P =0.030; 54%, 21%, 0% and 14.3 months and 29%, 10%, 0% and 7.6 months, respectively, χ2 =8.16, P =0.004). The MST of liver metastases was 6

  5. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer

    International Nuclear Information System (INIS)

    Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy. Several oral fluorouracil (5-FU) derivatives with different properties are available in Japan, but which drug is the most appropriate for each patient has not been established. Although efficacy prediction of 5-FU derivatives using expression of 5-FU activation/metabolism enzymes in tumors has been studied, it has not been clinically applied. The B-CAST study is a multicenter, prospective cohort study aimed to identify the patients who benefit from adjuvant chemotherapy with each 5-FU regimen, through evaluating the relationship between tumor biomarker expression and treatment outcome. The frozen tumor specimens of patients with stage III colon cancer who receives postoperative adjuvant chemotherapy are examined. Protein expression of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), epidermal growth factor receptor (EGFR), and vascular endothelial growth factor (VEGF) are evaluated using enzyme-linked immunosorbent assay (ELISA). mRNA expression of TP, DPD, thymidylate synthase (TS) and orotate phosphoribosyl transferase (OPRT) are evaluated using reverse transcription polymerase chain reaction (RT-PCR). The patients’ clinical data reviewed are as follow: demographic and pathological characteristics, regimen, drug doses and treatment duration of adjuvant therapy, types and severity of adverse events, disease free survival, relapse free survival and overall survival. Then, relationships among the protein/mRNA expression, clinicopathological characteristics and the treatment outcomes are analyzed for each 5-FU derivative. A total of 2,128 patients from the 217 institutions were enrolled between April 2009 and March 2012. The B-CAST study demonstrated that large-scale, multicenter translational research using frozen samples was feasible when the sample shipment and Web-based data collection were well organized. The results

  6. Gemcitabine and treatment of diffuse large B-cell lymphoma in relapsed or refractory elderly patients: A prospective randomized trial in Algeria

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    Aribi Mourad

    2010-01-01

    Full Text Available Context: Support for non-Hodgkin′s lymphoma (NHL with large cells that is refractory or relapsed after first-line chemotherapy poses a greater therapeutic problem with bone marrow transplant therapy or when old age is a contra-indication for high-dose chemotherapy, especially among developing countries such as Algeria. Aim: To show that the regimen, including gemcitabine, could be more effective in treating elderly patients with diffuse large B-cell lymphoma (DLBCL in relapse / refractory, without complete remission, when compared with the ESHAP (etoposide, cisplatine, solumedrol, aracytine regimen. Materials and Methods: Ninety-six patients in the age group of 60-70 years were volunteers for a prospective randomized single-blind study, carried out for three years. Patients were divided into two groups by the drawing of lots. The first group (GA, n = 48, relapse; n = 27 [56.3%], refractory; n = 21 [43.7%] received treatment with ESHAP protocol and the second one (GB, n = 48, relapse; n = 28 [58%], refractory; n = 20 [42%] with GPD (gemcitabine, dexamethasone, cisplatine protocol. Results: The overall response rates and mean survival at three years were significantly higher among patients subjected to GPD treatment compared with those subjected to ESHAP treatment (63% vs. 55%, P = 0.01 and 20.5% [95% CI 16.5-24.5] vs. 11.8% [8.9-14.6], respectively. Additionally, three-year progression-free and event-free survival rates were 20.5% (16.3-24 and 19.7% (15.9-23.5, respectively, for the GPD regimen and 10.9% (8.2-13.7 and 11.1% (95% CI 8.5-13.7, respectively, for the ESHAP regimen. Moreover, the GPD regimen was associated with improving overall survival (RR=2.02, 95% CI 1.59-2.56; P = 0.000, event-free survival (2.03, 1.64-2.52; P < 0.001 and progression-free survival (1.86, 1.46-2.37; P < 0.001. Conclusion: In cases of contra-indication for high-dose chemotherapy for elderly patients with DLBCL, without complete remission, the Gemcitabine

  7. Low-level laser therapy for treatment of chemotherapy-induced oral mucositis in childhood: a randomized double-blind controlled study.

    Science.gov (United States)

    Amadori, Francesca; Bardellini, Elena; Conti, Giulio; Pedrini, Nicola; Schumacher, Richard Fabian; Majorana, Alessandra

    2016-08-01

    The aim of this study was to verify if low-level laser therapy could be useful to reduce chemotherapy-related oral mucositis grading and pain in childhood undergoing chemotherapy. A randomized double-blind clinical trial was carried out. Patients from 3 to 18 years of age undergoing cancer therapy and presenting OM grade 2 or more were eligible for this study. Patients were randomly divided in two groups: group A received laser therapy from the day of OM diagnosis and other 3 consecutive days (830 nm wavelength, power 150 mW, spot size 1 cm(2), 30 s per cm(2), energy density 4.5 J/cm(2)); group B received sham therapy (placebo) with the same timing. Two blind clinicians performed OM scoring and pain evaluation at day 1 (immediately before the beginning of laser treatment-T0), day 4 (after finishing laser therapy cycle-T1) and at day 7 (T2) as follow-up. A total of 123 patients were included in the study. Group A was composed of 62 children while group B is 61; in both groups, there was a progressive reduction in grade of OM, and at day 7, not every mucosal lesion disappeared. The difference in the decline of OM grading between the two groups resulted not statistically significant (p = 0.07). A statistically significant difference in pain reduction between two groups both at T1 and at T2 (p < 0.005) was observed. This study demonstrated the efficacy of LLLT in reducing pain due to chemotherapy-induced oral mucositis in children, while no significant benefit was noted in reducing OM grade. PMID:27272517

  8. Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

    International Nuclear Information System (INIS)

    Purpose: To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer. Methods and Materials: In this open-label, randomized trial, 104 patients with histologically proven Stage IIB–IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m2, six cycles) and triweekly (cisplatin 75 mg/m2 every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years. Results: All patients tolerated both treatments very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3–4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154–0.914; p = 0.03). Conclusions: Triweekly cisplatin 75-mg/m2 chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m2 regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer.

  9. Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

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    Ryu, Sang-Young, E-mail: ryu@kcch.re.kr [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Lee, Won-Moo; Kim, Kidong [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Park, Sang-Il [Department of Gynecologic Oncology, Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of); Kim, Beob-Jong; Kim, Moon-Hong; Choi, Seok-Cheol [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Cho, Chul-Koo [Department of Radiation Oncology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Nam, Byung-Ho [Cancer Biostatistics Branch, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Lee, Eui-Don [Department of Gynecologic Oncology, Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of)

    2011-11-15

    Purpose: To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer. Methods and Materials: In this open-label, randomized trial, 104 patients with histologically proven Stage IIB-IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m{sup 2}, six cycles) and triweekly (cisplatin 75 mg/m{sup 2} every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years. Results: All patients tolerated both treatments very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3-4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154-0.914; p = 0.03). Conclusions: Triweekly cisplatin 75-mg/m{sup 2} chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m{sup 2} regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer.

  10. Prospective validation of immunological infiltrate for prediction of response to neoadjuvant chemotherapy in HER2-negative breast cancer--a substudy of the neoadjuvant GeparQuinto trial.

    Directory of Open Access Journals (Sweden)

    Yasmin Issa-Nummer

    Full Text Available INTRODUCTION: We have recently described an increased lymphocytic infiltration rate in breast carcinoma tissue is a significant response predictor for anthracycline/taxane-based neoadjuvant chemotherapy (NACT. The aim of this study was to prospectively validate the tumor-associated lymphocyte infiltrate as predictive marker for response to anthracycline/taxane-based NACT. PATIENTS AND METHODS: The immunological infiltrate was prospectively evaluated in a total of 313 core biopsies from HER2 negative patients of the multicenter PREDICT study, a substudy of the neoadjuvant GeparQuinto study. Intratumoral lymphocytes (iTuLy, stromal lymphocytes (strLy as well as lymphocyte-predominant breast cancer (LPBC were evaluated by histopathological assessment. Pathological complete response (pCR rates were analyzed and compared between the defined subgroups using the exact test of Fisher. RESULTS: Patients with lymphocyte-predominant breast cancer (LPBC had a significantly increased pCR rate of 36.6%, compared to non-LPBC patients (14.3%, p<0.001. LPBC and stromal lymphocytes were significantly independent predictors for pCR in multivariate analysis (LPBC: OR 2.7, p = 0.003, strLy: OR 1.2, p = 0.01. The amount of intratumoral lymphocytes was significantly predictive for pCR in univariate (OR 1.2, p = 0.01 but not in multivariate logistic regression analysis (OR 1.2, p = 0.11. CONCLUSION: Confirming previous investigations of our group, we have prospectively validated in an independent cohort that an increased immunological infiltrate in breast tumor tissue is predictive for response to anthracycline/taxane-based NACT. Patients with LPBC and increased stromal lymphocyte infiltration have significantly increased pCR rates. The lymphocytic infiltrate is a promising additional parameter for histopathological evaluation of breast cancer core biopsies.

  11. A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer.

    Science.gov (United States)

    Schwartzberg, Lee S; Yee, Lorrin K; Senecal, Frank M; Charu, Veena; Tomita, Dianne; Wallace, Joel; Rossi, Greg

    2004-01-01

    An important clinical question is the relative efficacy of the most common dosages of darbepoetin alfa (Aranesp; Amgen Inc.; Thousand Oaks, CA) 200 microg every 2 weeks (Q2W) and epoetin alfa (Procrit; Ortho Biotech Products, LP; Raritan, NJ) 40,000 U weekly (QW) for the treatment of chemotherapy-induced anemia. We designed three concurrent randomized, open-label, multicenter, identical trials (with the exception of tumor type criteria of breast, gynecologic, or lung cancer) of darbepoetin alfa and epoetin alfa in patients with chemotherapy-induced anemia to validate the Patient Satisfaction Questionnaire for Anemia (PSQ-An) treatment tool and to compare the efficacies and safety profiles of these two agents. In each trial, patients were randomized 1:1 to receive either darbepoetin alfa at a dose of 200 microg Q2W or epoetin alfa at a dose of 40,000 U QW for up to 16 weeks. The PSQ-An was assessed for validity, feasibility, and reliability. Secondary clinical endpoints were analyzed using the primary analysis set. Both individual trial analyses and a protocol-specified combined analysis of data from all three trials were conducted. Overall, 312 patients (157 darbepoetin alfa; 155 epoetin alfa) were randomized and received study drug. Baseline characteristics were similar in both treatment groups in each trial and overall. The PSQ-An was valid, feasible, and reliable. In general, no difference between treatment groups was observed for hemoglobin- and transfusion-based endpoints in each individual trial or in the combined analysis. From exploratory analyses, achievement and maintenance of a hemoglobin target range (11-13 g/dl) were similar in both groups. No differences in safety were observed. With the PSQ-An, formal comparisons of the impact of anemia therapies on patients and caregivers can be made in future prospective studies. Further, darbepoetin alfa (200 microg Q2W) and epoetin alfa (40,000 U QW) appear to achieve comparable clinical and hematologic outcomes

  12. Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Isabelle Bourdel-Marchasson

    Full Text Available We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy, versus usual care, on one-year mortality.We conducted a multicentre, open-label interventional, stratified (centre, parallel randomised controlled trial, with a 1∶1 ratio, with two-year follow-up. Patients were aged 70 years or older treated with chemotherapy for solid tumour and at risk of malnutrition (MNA, Mini Nutritional Assessment 17-23.5. Intervention consisted of diet counselling with the aim of achieving an energy intake of 30 kCal/kg body weight/d and 1.2 g protein/kg/d, by face-to-face discussion targeting the main nutritional symptoms, compared to usual care. Interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months. The primary endpoint was 1-year mortality and secondary endpoints were 2-year mortality, toxicities and chemotherapy outcomes.Between April 2007 and March 2010 we randomised 341 patients and 336 were analysed: mean (standard deviation age of 78.0 y (4·9, 51.2% male, mean MNA 20.2 (2.1. Distribution of cancer types was similar in the two groups; the most frequent were colon (22.4%, lymphoma (14.9%, lung (10.4%, and pancreas (17.0%. Both groups increased their dietary intake, but to a larger extent with intervention (p<0.01. At the second visit, the energy target was achieved in 57 (40.4% patients and the protein target in 66 (46.8% with the intervention compared respectively to 13 (13.5% and 20 (20.8% in the controls. Death occurred during the first year in 143 patients (42.56%, without difference according to the intervention (p = 0.79. No difference in nutritional status changes was found. Response to chemotherapy was also similar between the groups.Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes. Cancer cachexia antianabolism may explain this lack of effect.ClinicalTrials.gov NCT

  13. Role of oral glutamine in alleviation and prevention of radiation-induced oral mucositis: A prospective randomized study

    OpenAIRE

    Subrata Chattopadhyay; Aramita Saha; Mohammad Azam; Anindya Mukherjee; Prabir Kumar Sur

    2014-01-01

    Background: Oral mucositis is the most frequently occurring painful and dose-limiting side-effect of radiation of the head and neck region. Few studies demonstrated that oral glutamine suspension may significantly reduce the duration and severity of objective oral mucositis during radiotherapy. Materials and Methods: A randomized, prospective single institutional case control study was performed between April 2012 and November 2012 comparing the influence of oral glutamine on radiation induce...

  14. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial

    OpenAIRE

    Buchweitz, Olaf; Frye, Christian; Moeller, Claus Peter; Nugent, Wolfgang; Krueger, Eckart; Nugent, Andreas; Biel, Peter; Juergens, Sven

    2015-01-01

    Background In an elective laparoscopic surgery, the cosmetic outcome becomes increasingly important. We conducted a study to evaluate the cosmetic outcome 3 months after a laparoscopic procedure and compared skin adhesive (SA) versus transcutaneous suture (TS). Methods A randomized, controlled, prospective study was conducted at a single study centre in Hamburg, Germany. Seventy-seven patients undergoing laparoscopic surgery with two lower abdominal port sites met the study requirements. It w...

  15. Prospective Randomized Trial to Assess Effects of Continuing Hormone Therapy on Cerebral Function in Postmenopausal Women at Risk for Dementia

    OpenAIRE

    Rasgon, Natalie L.; Geist, Cheri L.; Kenna, Heather A.; Wroolie, Tonita E.; Williams, Katherine E.; Silverman, Daniel H. S.

    2014-01-01

    The objective of this study was to examine the effects of estrogen-based hormone therapy (HT) on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5) at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+) or discontinue (HT−) therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years,...

  16. Prospective randomized study to compare between intravenous dexmedetomidine and esmolol for attenuation of hemodynamic response to endotracheal intubation

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    Selvaraj, Venkatesh; Manoharan, Karthik Raj

    2016-01-01

    Background: Esmolol has an established role in attenuation of hemodynamic response to laryngoscopy and endotracheal intubation. We studied the effect of dexmedetomidine compared to that of esmolol in this study. Aim: To study the role of dexmedetomidine in attenuation of hemodynamic response to laryngoscopy and oral endotracheal intubation compared to that of esmolol hydrochloride in patients posted for elective surgery under general anesthesia. Study Design: Prospective randomized study doub...

  17. A Prospective, Randomized Comparison of Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab (Avastin) in Diffuse Diabetic Macular Edema

    OpenAIRE

    Shahin Maha; El-Lakkany Rasheed

    2010-01-01

    Purpose: To compare the functional and anatomical outcomes following intravitreal triamcinolone acetonide vs. intravitreal bevacizumab (Avastin) treatment for diffuse diabetic macular edema. Materials and Methods: In this prospective, randomized study, subjects were divided into two groups: 24 eyes that received intravitreal injection of 4 mg/0.1 mL triamcinolone acetonide (IVTA group) and 24 eyes received intravitreal injection of 1.25 mg/0.05 mL bevacizumab (IVB group). Changes in best ...

  18. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors.

    Science.gov (United States)

    Bloss, Cinnamon S; Wineinger, Nathan E; Peters, Melissa; Boeldt, Debra L; Ariniello, Lauren; Kim, Ju Young; Sheard, Judith; Komatireddy, Ravi; Barrett, Paddy; Topol, Eric J

    2016-01-01

    Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers-some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program-making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases or

  19. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  20. Radiotherapy for achillodynia. Results of a single-center prospective randomized dose-optimization trial

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    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-02-15

    Background and purpose: The aim of this study was to compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with achillodynia. Patients and methods: Between February 2006 and February 2010, 112 consecutive evaluable patients were recruited for this prospective randomized trial. All patients underwent radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions over 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy with a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 84% directly after and 88% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 55.7 {+-} 21.0 and 58.2 {+-} 23.5 (p = 0.526), 38.0 {+-} 23.2 and 30.4 {+-} 22.6 (p = 0.076), and 35.4 {+-} 25.9 and 30.9 {+-} 25.4 (p = 0.521), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 8.2 {+-} 3.0 and 8.9 {+-} 3.3 (p = 0.239), 5.6 {+-} 3.1 and 5.4 {+-} 3.3 (p = 0.756), 4.4 {+-} 2.6 and 5.3 {+-} 3.8 (p = 0.577), respectively. No statistically significant differences were found between the two single-dose trial arms for early (p = 0.366) and delayed response (p = 0.287). Conclusion: Radiotherapy is an effective treatment option for the management of achillodynia. For radiation protection, the dose of a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  1. Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial

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    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2012-10-15

    Background and purpose: The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Patients and methods: Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 {+-} 20.2 and 55.7 {+-} 18.0 (p = 0.463), 32.1 {+-} 24.5 and 34.4 {+-} 22.5 (p = 0.256), and 27.0 {+-} 27.7 and 23.5 {+-} 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 {+-} 2.9 and 8.1 {+-} 3.1 (p = 0.207), 4.5 {+-} 3.2 and 5.0 {+-} 3.4 (p = 0.507), 3.9 {+-} 3.6 and 2.8 {+-} 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. Conclusion: RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy. (orig.)

  2. Comparative analysis of conventional and eversion carotid endarterectomy: Prospective randomized study

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    Marković Dragan M.

    2008-01-01

    Full Text Available INTRODUCTION Studies completed in the last decade of the 20th century showed benefits of carotid endarterectomy in the prevention of stroke in patients with a high-grade stenosis of the internal carotid artery. OBJECTIVE The aim of this prospective, randomized study was the comparison of early and long-term results between the conventional and eversion carotid endarterectomy, and literature review. METHOD By the method of random choice, 103 patients were operated on using the eversion carotid endarterectomy and 98 patients using the conventional technique. Operative treatment was carried out under general anaesthesia. Following the clammping of the carotid artery, retrograde blood pressure was determined by a direct puncture of the internal carotid artery above the stenotic lesions. In patients with retrograde pressure below 20 mm Hg intraluminal shunting was routinely performed. Early results were estimated (during the first seven postoperative days based on mortality, central neurological complications (stroke, TIA and cranial or cervical nerve lesions. Long-term results were estimated (after at least two years based on long-term survival rate, central neurological complications (stroke, TIA and the incidence of haemodynamically significant restenosis of the carotid artery treated by endarterectomy. RESULTS The average time of clamming of the internal carotid artery in the eversion carotid anderectomy group was 5.36 minutes shorter than in the group treated by the conventional technique. Student's t-test showed a statistically highly significant difference in the time needed for clamming of the internal carotid artery between the two groups. The average duration of eversion endarterectomy (82 minutes was most often 19 minutes shorter than the duration of the conventional endarterectomy (101 minutes. Student's t-test showed a statistically highly significant difference in the average length of surgeries. The distal intimal fixation was more

  3. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients.

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    Ransford, A O; Morley, T; Edgar, M A; Webb, P; Passuti, N; Chopin, D; Morin, C; Michel, F; Garin, C; Pries, D

    1998-01-01

    We have evaluated the use of a synthetic porous ceramic (Triosite) as a substitute for bone graft in posterior spinal fusion for idiopathic scoliosis. In a prospective, randomised study 341 patients at five hospitals in the UK and France were randomly allocated either to autograft from the iliac crest or rib segments (171) or to receive Triosite blocks (170). All patients were assessed after operation and at 3, 6, 12 and 18 months. The two groups were similar with regard to all demographic and baseline variables, but the 184 treated in France (54%) had Cotrel-Dubouset instrumentation and the 157 treated in the UK usually had Harrington-Luque implants. In the Triosite group the average Cobb angle of the upper curve was 56 degrees, corrected to 24 degrees (57%). At 18 months, the average was 26 degrees (3% loss). In the autograft group the average preoperative upper curve of 53 degrees was corrected to 21 degrees (60%). At 18 months the mean curve was 25 degrees (8% loss). Pain levels after operation were similar in the two groups, being mild in most cases. In the Triosite group only three patients had problems of wound healing, but in the autograft group, 14 patients had delayed healing, infection or haematoma in the spinal wound. In addition, 15 autograft patients had pain at the donor site at three months. Seven had infections, two had haematoma and four had delayed healing. The haematological and serum biochemistry results showed no abnormal trends and no significant differences between the groups. There were no adverse events related to the graft material and no evidence of allergenicity. Our results suggest that Triosite synthetic porous ceramic is a safe and effective substitute for autograft in these patients. Histological findings on biopsy indicate that Triosite provides a favourable scaffolding for the formation of new bone and is gradually incorporated into the fusion mass. PMID:9460945

  4. Comparative evaluation of left ventricular mass regression after aortic valve replacement: a prospective randomized analysis

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    Kiessling Arndt H

    2011-10-01

    Full Text Available Abstract Background We assessed the hemodynamic performance of various prostheses and the clinical outcomes after aortic valve replacement, in different age groups. Methods One-hundred-and-twenty patients with isolated aortic valve stenosis were included in this prospective randomized randomised trial and allocated in three age-groups to receive either pulmonary autograft (PA, n = 20 or mechanical prosthesis (MP, Edwards Mira n = 20 in group 1 (age 75. Clinical outcomes and hemodynamic performance were evaluated at discharge, six months and one year. Results In group 1, patients with PA had significantly lower mean gradients than the MP (2.6 vs. 10.9 mmHg, p = 0.0005 with comparable left ventricular mass regression (LVMR. Morbidity included 1 stroke in the PA population and 1 gastrointestinal bleeding in the MP subgroup. In group 2, mean gradients did not differ significantly between both populations (7.0 vs. 8.9 mmHg, p = 0.81. The rate of LVMR and EF were comparable at 12 months; each group with one mortality. Morbidity included 1 stroke and 1 gastrointestinal bleeding in the stentless and 3 bleeding complications in the MP group. In group 3, mean gradients did not differ significantly (7.8 vs 6.5 mmHg, p = 0.06. Postoperative EF and LVMR were comparable. There were 3 deaths in the stented group and no mortality in the stentless group. Morbidity included 1 endocarditis and 1 stroke in the stentless compared to 1 endocarditis, 1 stroke and one pulmonary embolism in the stented group. Conclusions Clinical outcomes justify valve replacement with either valve substitute in the respective age groups. The PA hemodynamically outperformed the MPs. Stentless valves however, did not demonstrate significantly superior hemodynamics or outcomes in comparison to stented bioprosthesis or MPs.

  5. OZONE NUCLEOLYSIS IN LUMBAR INTERVERTEBRAL DISC HERNIATION: NON - RANDOMIZED PROSPECTIVE ANALYSIS

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    Vivekananda S

    2015-05-01

    Full Text Available STUDY DESI GN: Non - randomized, prospective analysis of 68 patients of lumbar disc herniation treated with ozone nucleolysis. OBJECTIVE: To assess the patients with lumbar disc herniation treated with intradiscal ozone, pre and post ozone nucleolysis, for pain using Visual Analog Scale (VAS functional & disability score using Japanese Orthopedic Association (JOA Clinical Symptom Score. SUMMARY OF BACKGROUN D DATA: Ozone therapy for disc herniation is becoming popu lar because of its minimal invasive, lesser recurrences and remarkably fewer side effects. Successful outcomes of ozone therapy have been reported from various European & Indian centers. METHODS: A series of 68 patients were treated with ozone therapy for lumbar disc herniation from January 2009 to January 2012. The procedure is done under C - arm guidance under local anesthesia by “Single sitting double injection technique”. All patients were assessed using VAS for radiation pain & back pain, Clinical Symptom Score of the Japanese Orthopaedic Association (JOA for a Patient with Lumbar Disc Herniation, pre op and post op, on day one, after a week, two weeks, first month, third months, sixth month one year second year. Were classified them as Good, Moder ate & Poor outcome. RESULTS: Out of 68 patients 89.7% (61/68 patients had good outcome, 7.35% (5/68 patients had moderate outcome, 2.95% (2/68 had poor outcome. Intra - op in 1 patient where ozone spread in Para spinal muscles but had no postoperative pro blem.4 patients had mild nausea, 2 had mild headache & No infection. CONCLUSIONS: Ozone nucleolysis is a new, minimally invasive procedure done under local anesthesia & has shown effective results in the treatment of contained intervertebral disc herniatio n with no side effects.

  6. Partial splenic embolization using polyvinyl alcohol particles for hypersplenism in cirrhosis: A prospective randomized study

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    Zhu Kangshun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: zhksh010@163.com; Meng Xiaochun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: mengxiaochun1972@163.com; Li Zhengran [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: andyreede@21cn.com; Huang Mingsheng [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: laom502@tom.com; Guan Shouhai [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: guanshouhai@163.com; Jiang Zaibo [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: jiangzaibo@yahoo.com.cn; Shan Hong [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: gzshsums@public.guangzhou.gd.cn

    2008-04-15

    Purpose: To prospectively evaluate the efficacy and safety of partial splenic embolization (PSE) using polyvinyl alcohol (PVA) particles for hypersplenism in cirrhosis, as compared to PSE using gelfoam particles. Materials and methods: PSE was performed in 60 consecutive patients with hypersplenism caused by cirrhosis. The patients were randomly assigned into 2 groups: gelfoam group, 32 patients received PSE using gelfoam particles as the embolic material; PVA group, 28 patients received PSE using PVA particles. The follow-up contents included peripheral blood cell counts (leukocyte, platelet and red blood cell) and complications associated with PSE. Results: Prior to PSE, there was no significant difference between the two groups in sex, age, Child-Pugh grade, the extent of embolization and peripheral blood cell counts. After PSE, no matter in which group, leukocyte and platelet counts kept significantly higher than pre-PSE during the 3-year follow-up period (P < .0001), but the post-PSE improvement of leukocyte and platelet counts was significantly better in PVA group than in gelfoam group (P < .05). Red blood cell counts showed no remarkable changes after PSE (P > .05). Severe complications occurred in 8 patients (25.0%) in gelfoam group and 6 patients (21.4%) in PVA group (P > .05), but the degree of abdominal pain was higher in the latter than in the former (P < .05). Among 17 patients who received more than 70% embolization of spleen, 10 (58.8%) developed severe complications, while among 43 patients who received 70% or less embolization of spleen, only four (9.3%) had severe complications. This difference was statistically significant (P < .05). Conclusion: PVA particles could be used as the embolic material in PSE; in comparison with PSE using gelfoam particles, PSE using PVA particles can achieve even better efficacy in alleviating hypersplenism, but the extent of embolization should be strictly limited to not more than 70% of splenic volume.

  7. Benefits of immediate jejunostomy feeding after major abdominal trauma--a prospective, randomized study.

    Science.gov (United States)

    Moore, E E; Jones, T N

    1986-10-01

    Benefits of immediate postinjury nutritional support remain ill defined. Seventy-five consecutive patients undergoing emergent celiotomy with an abdominal trauma index (A.T.I.) greater than 15 were randomized prospectively to a control group (no supplemental nutrition during first 5 days) or enteral-fed group. The enteral patients had a needle catheter jejunostomy (N.C.J.) placed at laparotomy with the constant infusion of an elemental diet (Vivonex HN) begun at 18 hours and advanced to 3,000 ml/day (3,000 kcal, 20 gm N2) within 72 hours. Control and enteral-fed groups were comparable with respect to demographic features, trauma mechanism, shock, colon injury, splenectomy, A.T.I., and initial nutritional assessment. Twenty (63%) of the enteral patients were maintained on the elemental diet greater than 5 days; four (12%) needed total parenteral nutrition (T.P.N.). Nine (29%) of the control patients required T.P.N. Nitrogen balance was markedly improved (p less than 0.001) in the enteral-fed group. Although visceral protein markers and overall complication rate were not significantly different, septic morbidity was greater (p less than 0.025) in the control group (abdominal infection in seven and pneumonia in two) compared to the enteral-fed patients (abdominal abscess in three). Analysis of patients with A.T.I. 15-40 disclosed sepsis in seven (26%) of the control versus one (4%) of the enteral-fed group (p less than 0.01). Our clinical experience demonstrates the feasibility of immediate postoperative enteral feeding via N.C.J. after major abdominal trauma, and suggests this early nutrition reduces septic complications in critically injured patients. PMID:3095557

  8. Prospective Randomized Trial Comparing Hepatic Venous Outflow and Renal Function after Conventional versus Piggyback Liver Transplantation.

    Directory of Open Access Journals (Sweden)

    Marília D'Elboux Guimarães Brescia

    Full Text Available This randomized prospective clinical trial compared the hepatic venous outflow drainage and renal function after conventional with venovenous bypass (n = 15 or piggyback (n = 17 liver transplantation.Free hepatic vein pressure (FHVP and central venous pressure (CVP measurements were performed after graft reperfusion. Postoperative serum creatinine (Cr was measured daily on the first week and on the 14th, 21st and 28th postoperative days (PO. The prevalence of acute renal failure (ARF up to the 28th PO was analyzed by RIFLE-AKIN criteria. A Generalized Estimating Equation (GEE approach was used for comparison of longitudinal measurements of renal function.FHVP-CVP gradient > 3 mm Hg was observed in 26.7% (4/15 of the patients in the conventional group and in 17.6% (3/17 in the piggyback group (p = 0.68. Median FHVP-CVP gradient was 2 mm Hg (0-8 mmHg vs. 3 mm Hg (0-7 mm Hg in conventional and piggyback groups, respectively (p = 0.73. There is no statistically significant difference between the conventional (1/15 and the piggyback (2/17 groups regarding massive ascites development (p = 1.00. GEE estimated marginal mean for Cr was significantly higher in conventional than in piggyback group (2.14 ± 0.26 vs. 1.47 ± 0.15 mg/dL; p = 0.02. The conventional method presented a higher prevalence of severe ARF during the first 28 PO days (OR = 3.207; 95% CI, 1.010 to 10.179; p = 0.048.Patients submitted to liver transplantation using conventional or piggyback methods present similar results regarding venous outflow drainage of the graft. Conventional with venovenous bypass technique significantly increases the harm of postoperative renal dysfunction.ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01707810.

  9. Impact of Epidural Failures on the Results of a Prospective, Randomized Trial.

    Science.gov (United States)

    Desai, Amita; Alemayehu, Hanna; Weesner, Kathryn A; St Peter, Shawn D

    2016-04-01

    Introduction We conducted a prospective randomized trial to evaluate the merits of two established postoperative pain management strategies: thoracic epidural (EPI) versus patient-controlled analgesia (PCA) with intravenous narcotics after minimally invasive repair of pectus excavatum. Pain scores favored the EPI group for the first two postoperative days only. Critics of the trial suggest that if the epidural failure rate was not so high, results may have favored the EPI group. Therefore, we performed a subset analysis of the EPI group to evaluate the impact of these failures. Methods Patients for whom epidural catheter could not be placed or whose catheters were removed early owing to dysfunction were compared with those with well-functioning catheters. Those with well-functioning catheters were also compared with the PCA group. A two-tailed independent Student t-test and a two-tailed Fisher exact test were used where appropriate. Results Of 55 patients in the EPI group, 12 patients (21.8%) had failed placement or required early removal. Comparing those with failed placements with the rest of the group, there was no difference in daily visual analogue scale pain scores or measures of hospital course. Likewise, comparing those with well-functioning catheters only to those in the PCA group, the results of the trial are replicated in terms of pain scores, hospital course, and length of stay. Conclusion In patients with failed epidural therapy, there is no significant difference in postoperative hospital course. Comparing those with well-functioning catheters to those in the PCA group, trial results are replicated-that is, no significant difference in length of stay, time to regular diet, or time to transition to oral medications. Therefore, failure rate in the EPI group did not influence the results of the trial. PMID:25643246

  10. Navigation of total knee arthroplasty: rotation of components and clinical results in a prospectively randomized study

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    Efe Turgay

    2011-01-01

    Full Text Available Abstract Background Navigation was introduced into total knee arthroplasty (TKA to improve accuracy of component position, function and survival of implants. This study was designed to assess the outcome of navigated TKA in comparison with conventional implantation with the focus on rotational component position and clinical mid-term results. Methods In a prospectively randomized single-blinded approach, 90 patients with primary gonarthrosis were assigned to three different groups. Thirty patients each were assigned to NexGen LPS without and with navigation (groups 1 and 2, and 30 patients to navigation with the Stryker Scorpio PS (group 3. The navigation system used was the imageless Stryker KneeTrac, version 1.0. Clinical outcome was assessed by a blinded observer applying the Knee Society Score (KSS and a visual analogue scale (VAS for pain. CT scans and radiographs were conducted prior to and 12 weeks after index surgery. Results Seventy-nine patients were available for clinical evaluation at 3 ± 0.4 years follow-up. Four implants had to be revised for early loosening or infection (4.4%. Four patients had died and three patients were not able to follow the invitation for clinical assessment. Functional results in the KSS were significantly lower after navigated TKA. Operation time and incisions with navigation were significantly longer. Significantly less radiological outliers with navigation were found for coronal alignment of the femur, only. Conclusion In this series, no beneficial effect for navigation in TKA could be shown assessing clinical data, as functional results in the presented series seemed to be lower after first generation navigated TKA. The clinical mid- to long-term value of navigation remains to be evaluated in larger patient series or meta-analyses at longer follow-up. Trial registration number DRKS 00000430

  11. A prospective neurocognitive evaluation of children treated with additional chemotherapy and craniospinal irradiation following isolated central nervous system relapse in acute lymphoblastic leukemia

    International Nuclear Information System (INIS)

    Purpose: A prospective assessment of neurocognitive performance was conducted in children with acute lymphoblastic leukemia (ALL) following isolated central nervous system (CNS) relapse to evaluate the impact of additional systemic/intrathecal (IT) chemotherapy and craniospinal irradiation (CSI) upon long-term intellectual function. Methods and Materials: Twenty-one children with ALL manifesting an isolated CNS relapse between 1984 through 1989 underwent serial evaluations of intellectual function. Neurocognitive function was measured by the full-scale intelligence quotient (FSIQ) as determined by the age-appropriate Wechsler Intelligence Scale and by achievement in reading, math, and spelling as assessed by the Wide Range Achievement Test (WRAT). Intelligence testing was initiated following isolated CNS relapse after clearance of cerebrospinal fluid (CSF) cytology but prior to CSI and continued at annual intervals for a minimum of 4 years postmeningeal failure. Protocol treatment for isolated CNS relapse consisted of reinduction and maintenance systemic therapy, intrathecal (IT) triple-agent chemotherapy, and early CSI (cranium to 24 Gy and spine to 15 Gy at 1.5 Gy/fraction) as outlined on the institutional 'Total XI' trial. Results: All 21 children attained secondary CNS remission and underwent the planned additional systemic/IT chemotherapy and CSI. Fourteen of the 21 children remain in secondary continuous remission, while the remaining 7 experienced a second relapse and were removed from further neurocognitive assessment. For the eight female and six male long-term survivors, mean ages at original diagnosis and at CSI were 5.7 years (range = 0.6-16.2) and 7.0 years (range = 1.8-17.0), respectively. At a median follow-up interval of 4.6 years (ranges 1.7-6.8) post-CNS relapse, comparison of group mean initial to final FSIQs revealed no statistically significant difference between the two measures (94.5 vs. 95.9, respectively, n = 11, p = 0.52). None of the

  12. Chemotherapy Effects

    Science.gov (United States)

    ... saved articles window. My Saved Articles » My ACS » Chemotherapy Side Effects Chemotherapy drugs are powerful medicines that can cause side ... on the side effects most commonly caused by chemotherapy, this is a good place to start. Managing ...

  13. Understanding Chemotherapy

    Science.gov (United States)

    N ational C ancer I nstitute Understanding Chemotherapy What is chemotherapy? Chemotherapy is a cancer treatment that uses drugs to destroy cancer cells. It is also called “chemo.” Today, there are ...

  14. Randomized Phase II Study of Gefitinib Compared With Placebo in Chemotherapy-Naive Patients With Advanced Non–Small-Cell Lung Cancer and Poor Performance Status

    Science.gov (United States)

    Goss, Glenwood; Ferry, David; Wierzbicki, Rafal; Laurie, Scott A.; Thompson, Joyce; Biesma, Bonne; Hirsch, Fred R.; Varella-Garcia, Marileila; Duffield, Emma; Ataman, Ozlem U.; Zarenda, Marc; Armour, Alison A.

    2009-01-01

    Purpose To compare gefitinib with placebo in chemotherapy naïve patients with advanced non–small-cell lung cancer (NSCLC) and poor performance status. Patients and Methods NSCLC patients (chemotherapy naïve, WHO performance status 2 or 3; unfit for chemotherapy; stage IIIB/IV) were randomly assigned to gefitinib (250 mg/d) plus best supportive care (BSC; n = 100) or placebo plus BSC (n = 101). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), quality of life (QOL), pulmonary symptom improvement (PSI), and safety. Correlation of gefitinib efficacy with EGFR gene copy number (fluorescent in situ hybridization [FISH]) was explored. Results Hazard ratios (HRs; gefitinib:placebo) were 0.82 (95% CI, 0.60 to 1.12; P = .217) for PFS and 0.84 (95% CI, 0.62 to 1.15; P = .272) for OS. As expected for this patient population, OS for both arms was poor, at about 3 months. ORRs were 6.0% (gefitinib) and 1.0% (placebo). QOL and PSI rates were 21.1% and 28.3% (gefitinib) and 20.0% and 28.3% (placebo), respectively. In EGFR FISH-positive patients (n = 32), HRs were 0.29 (95% CI, 0.11 to 0.73) for PFS and 0.44 (95% CI, 0.17 to 1.12) for OS. No unexpected adverse events occurred. Conclusion There was no statistically significant difference in PFS, OS, and ORRs after treatment with gefitinib or placebo, in the overall population; improvements in QOL and symptoms were similar in both groups. Tolerability profile of gefitinib was consistent with previous studies. PFS was statistically significantly improved for gefitinib-treated patients with EGFR FISH-positive tumors. PMID:19289623

  15. Magnitude of benefit of the addition of bevacizumab to first-line chemotherapy for metastatic colorectal cancer: meta-analysis of randomized clinical trials

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    Falcone Alfredo

    2010-05-01

    Full Text Available Abstract Background Although the addition of bevacizumab to 1st line chemotherapy provides a significant survival benefit for advanced colorectal cancer, the magnitudes of both advantages and toxicities have not been extensively investigated. Methods A literature-based meta-analysis was conducted; Hazard Ratios were extracted from randomized trials for primary end-points (Progression Free Survival, PFS, Overall Survival OS. The log of event-based risk ratio were derived for secondary endpoints (objective/partial response rate, ORR/PR; severe hypertension, bleeding and proteinuria. Absolute differences and the number needed to treat/harm (NNT/NNH were calculated. A meta-regression analysis with clinical predictors and a sensitivity analysis according to the trial phase-design were conducted as well. Results Five trials (2,728 pts were selected. The addition of bevacizumab to 1st line chemotherapy significantly increased both PFS (although with significant heterogeneity and OS over exclusive chemotherapy by 17.1% and 8.6% (NNT 6 and 12, regardless of the study setting (non significant interaction between phase II and III. The chance to improve PR was significantly increased by 6.5% (NNT 15, with a trend for ORR. The risk of hypertension was significantly increased by 6.2% (NNH 16. According to the meta-regression analysis, female gender and rectal primary site were significant predictors for PFS benefit. Conclusions Notwithstanding all the concerns related to costs and the significant HTN risk, the significant outcome improvement provided by bevacizumab in first-line treatment for unselected advanced colorectal cancer patients, should be considered when choosing the appropriate up-front therapy.

  16. Enzalutamide treatment in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy and abiraterone acetate

    DEFF Research Database (Denmark)

    Thomsen, Frederik Birkebaek; Røder, Martin Andreas; Rathenborg, Per;

    2014-01-01

    OBJECTIVE: The aim of this study was to record prostate-specific antigen (PSA) response and overall survival (OS) for a group of metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide following progression after abiraterone treatment in the post-chemotherapy...... marked fall in PSA following enzalutamide therapy in post-chemotherapy mCRPC patients compared with reported results in randomized trials. Larger prospective studies of sequencing are warranted....

  17. Impact of Diabetes Mellitus on the Treatment Outcomes of Chemotherapy in Women with Breast Cancer-A Population-Based Prospective Cohort Study

    Institute of Scientific and Technical Information of China (English)

    Yu-Ching Chen; Cheng-Wei Chang; Jorng-Tzong Horng; Yan-Jun Chen; Jin-Tsung Yang

    2015-01-01

    Abstract¾There are few population-based data in investigating the impact of diabetes on chemotherapy adverse effects and treatment outcomes of non-metastatic breast cancer. The purpose of this study is to evaluate whether diabetes affects the patterns of use in chemotherapy, toxic effects of chemotherapy, and treatment outcomes for non-metastatic breast cancer in Taiwan. The study results can provide physicians for making a decision whether or not to use chemotherapy based on the individual patients’ condition.

  18. A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy

    Directory of Open Access Journals (Sweden)

    Ballmer Andrea

    2010-03-01

    Full Text Available Abstract Background The endothelin system is implicated in the pathogenesis of melanoma. We evaluated the effects of bosentan - a dual endothelin receptor antagonist - in patients receiving first-line dacarbazine therapy for stage IV metastatic cutaneous melanoma in a phase 2, proof-of-concept study. Results Eligible patients had metastatic cutaneous melanoma naïve to chemotherapy or immunotherapy, no central nervous system involvement, and serum lactate dehydrogenase 2 every three weeks. Eighty patients were randomized (double-blind and 38 in each group received study treatment. Median time to tumor progression (primary endpoint was not significantly different between the two groups (placebo, 2.8 months; bosentan, 1.6 months; bosentan/placebo hazard ratio, 1.144; 95% CI, 0.717-1.827; p = 0.5683. Incidences of most adverse events and clinically relevant increases in hepatic transaminases were similar between treatment groups although hemoglobin decrease to >8 and ≤ 10 g/dL and ≤ 8 g/dL was more common in the bosentan group. Conclusions In patients receiving dacarbazine as first-line chemotherapy for metastatic melanoma, the addition of high-dose bosentan had no effect on time to tumor progression or other efficacy parameters. There were no unexpected safety findings. Trial registration This study is registered in ClinicalTrials.gov under the unique identifier NCT01009177.

  19. Supratentorial primitive neuroectodermal tumors (S-PNET) in children: A prospective experience with adjuvant intensive chemotherapy and hyperfractionated accelerated radiotherapy

    International Nuclear Information System (INIS)

    Purpose: Supratentorial primitive neuroectodermal tumors (S-PNET) are rare and have a grim prognosis, frequently taking an aggressive course with local relapse and metastatic spread. We report the results of a mono-institutional therapeutic trial. Methods and Materials: We enrolled 15 consecutive patients to preradiation chemotherapy (CT) consisting of high-dose methotrexate, high-dose etoposide, high-dose cyclophosphamide, and high-dose carboplatin, craniospinal irradiation (CSI) with hyperfractionated accelerated radiotherapy (HART) plus focal boost, maintenance with vincristine/lomustine or consolidation with high-dose thiotepa followed by autologous stem-cell rescue. Results: Median age was 9 years; 7 were male, 8 female. Site of disease was pineal in 3, elsewhere in 12. Six patients were had no evidence of disease after surgery (NED). Of those with evidence of disease after surgery (ED), 2 had central nervous system spread. Of the 9 ED patients, 2 had complete response (CR) and 2 partial response (PR) after CT, 4 stable disease, and 1 progressive disease. Of the 7 ED patients before radiotherapy, 1 had CR, 4 PR, and 2 minor response, thus obtaining a 44% CR + PR after CT and 71% after HART. Because of rapid progression in 2 of the first 5 patients, high-dose thiotepa was systematically adopted after HART in the subsequent 10 patients. Six of 15 patients relapsed (4 locally, 1 locally with dissemination, 1 with dissemination) a mean of 6 months after starting CT, 2 developed second tumors; 5 of 6 relapsers died at a median of 13 months. Three-year progression-free survival, event-free survival, and overall survival were 54%, 34%, and 61%, respectively. Conclusion: Hyperfractionated accelerated RT was the main tool in obtaining responses in S-PNET; introducing the myeloablative phase improved the prognosis (3/10 vs. 3/5 relapses), though the outcome remained unsatisfactory despite the adoption of this intensive treatment

  20. Treatment outcomes in patients with multiple brain metastases: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Animesh Saha

    2014-01-01

    Full Text Available Context: There is controversy regarding the radiotherapeutic dose fractionation in brain metastases (bm. Aims: The aim of this study is to analyze the treatment outcomes in patients with multiple bm. Settings and Design: Prospective, randomized study. Subjects and Methods: Patients with multiple bm with Eastern Cooperative Oncology Group performance status ≤2 were included. In arm-A patient received whole brain radiotherapy (WBRT 30 GY in 10# over 2 weeks and in arm-B patients received 20 GY in 5# over 1 week. Assessment of improvement in clinical symptoms was done using Barthel′s adjusted daily live (ADL score. Assessment of radiological response was done using magnetic resonance imaging scan of brain after 3 months of completion of external beam radiation therapy. Acute radiation toxicity was assessed using Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer acute radiation morbidity scoring. Statistical Analysis Used: Chi-square test was used to compare categorical variables between groups. Overall survival was computed by Kaplan-Meier survival analysis and Log-Rank test used for comparison of survival plots. For change in quality-of-life during treatment and follow-up, repeated measures ANOVA were used. Results: In both arms, there was a significant improvement in ADL score after treatment, but when two arms were compared, no significant difference was found between the two treatment arms. There was no statistically significant difference in response or morbidity between the two treatment arms. Median survival was 29 weeks in arm-A compared to 25.86 weeks in patients arm-B. Kaplan-Meier Survival curve analysis shows no significant difference in survival between the two arms. Conclusions: 20 GY in 5 fractions is equally effective with that of the 30 GY in 10 fractions for WBRT in bm. In the palliative setting short duration of treatment with minimum discomfort to the patient is desirable. Hence, we

  1. Video-assisted thoracic surgery reduces early postoperative stress. A single-institutional prospective randomized study

    Science.gov (United States)

    Asteriou, Christos; Lazopoulos, Achilleas; Rallis, Thomas; Gogakos, Apostolos S; Paliouras, Dimitrios; Tsakiridis, Kosmas; Zissimopoulos, Athanasios; Tsavlis, Drosos; Porpodis, Konstantinos; Hohenforst-Schmidt, Wolfgang; Kioumis, Ioannis; Organtzis, John; Zarogoulidis, Konstantinos; Zarogoulidis, Paul; Barbetakis, Nikolaos

    2016-01-01

    Background Video-assisted thoracic surgery (VATS) has been shown to effectively reduce postoperative pain, enhance mobilization of the patients, shorten in-hospital length of stay, and minimize postoperative morbidity rates. The aim of this prospective study is to evaluate neuroendocrine and respiratory parameters as stress markers in cancer patients who underwent lung wedge resections, using both mini muscle-sparing thoracotomy and VATS approach. Methods The patients were randomly allocated into two groups: Group A (n=30) involved patients who were operated on using the VATS approach, while in group B (n=30), the mini muscle-sparing thoracotomy approach was used. Neuroendocrine and biological variables assessed included blood glucose levels, C-reactive protein (CRP) levels, cortisol, epinephrine, and adrenocorticotropic hormone (ACTH) levels. Arterial oxygen (PaO2) and carbon dioxide (PaCO2) partial pressure were also evaluated. All parameters were measured at the following time points: 24 hours preoperatively (T1), 4 hours (T2), 24 hours (T3), 48 hours (T4), and 72 hours (T5), after the procedure. Results PaO2 levels were significantly higher 4 and 24 hours postoperatively in group A vs group B, respectively (T2: 94.3 vs 77.9 mmHg, P=0.015, T3: 96.4 vs 88.7 mmHg, P=0.034). Blood glucose (T2: 148 vs 163 mg/dL, P=0.045, T3: 133 vs 159 mg/dL, P=0.009) and CRP values (T2: 1.6 vs 2.5 mg/dL, P=0.024, T3: 1.5 vs 2.1 mg/dL, P=0.044) were found increased in both groups 4 and 24 hours after the procedure. However, their levels were significantly lower in the VATS group of patients. ACTH and cortisol values were elevated immediately after the operation and became normal after 48 hours in both groups, without significant difference. Postoperative epinephrine levels measured in group A vs group B, respectively, (T2: 78.9 vs 115.6 ng/L, P=0.007, T3: 83.4 vs 122.5 ng/L, P=0.012, T4: 67.4 vs 102.6 ng/L, P=0.021). The levels were significantly higher in group B. Conclusion This

  2. A prospective evaluation of treatment with Selective Internal Radiation Therapy (SIR-spheres) in patients with unresectable liver metastases from colorectal cancer previously treated with 5-FU based chemotherapy

    International Nuclear Information System (INIS)

    To prospectively evaluate the efficacy and safety of selective internal radiation (SIR) spheres in patients with inoperable liver metastases from colorectal cancer who have failed 5FU based chemotherapy. Patients were prospectively enrolled at three Australian centres. All patients had previously received 5-FU based chemotherapy for metastatic colorectal cancer. Patients were ECOG 0–2 and had liver dominant or liver only disease. Concurrent 5-FU was given at investigator discretion. Thirty patients were treated between January 2002 and March 2004. As of July 2004 the median follow-up is 18.3 months. Median patient age was 61.7 years (range 36 – 77). Twenty-nine patients are evaluable for toxicity and response. There were 10 partial responses (33%), with the median duration of response being 8.3 months (range 2–18) and median time to progression of 5.3 mths. Response rates were lower (21%) and progression free survival shorter (3.9 mths) in patients that had received all standard chemotherapy options (n = 14). No responses were seen in patients with a poor performance status (n = 3) or extrahepatic disease (n = 6). Overall treatment related toxicity was acceptable, however significant late toxicity included 4 cases of gastric ulceration. In patients with metastatic colorectal cancer that have previously received treatment with 5-FU based chemotherapy, treatment with SIR-spheres has demonstrated encouraging activity. Further studies are required to better define the subsets of patients most likely to respond

  3. Impact of resistance and aerobic exercise on sarcopenia and dynapenia in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial.

    Science.gov (United States)

    Adams, Scott C; Segal, Roanne J; McKenzie, Donald C; Vallerand, James R; Morielli, Andria R; Mackey, John R; Gelmon, Karen; Friedenreich, Christine M; Reid, Robert D; Courneya, Kerry S

    2016-08-01

    The purpose of this study was to conduct an exploratory analysis of the START examining the effects of resistance exercise training (RET) and aerobic exercise training (AET) on sarcopenia, dynapenia, and associated quality of life (QoL) changes in breast cancer (BC) patients receiving adjuvant chemotherapy. Participants were randomized to usual care (UC) (n = 70), AET (n = 64), or RET (n = 66) for the duration of chemotherapy. Measures of sarcopenia [skeletal muscle index (SMI)] and dynapenia [upper extremity (UE) and lower extremity (LE) muscle dysfunction (MD)] were normalized relative to age-/sex-based clinical cut-points. QoL was assessed by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) scales. At baseline, 25.5 % of BC patients were sarcopenic and 54.5 % were dynapenic with both conditions associated with poorer QoL. ANCOVAs showed significant differences favoring RET over UC for SMI (0.32 kg/m(2); p = 0.017), UE-MD (0.12 kg/kg; p < 0.001), and LE-MD (0.27 kg/kg; p < 0.001). Chi-square analyses revealed significant effects of RET, compared to UC/AET combined, on reversing sarcopenia (p = 0.039) and dynapenia (p = 0.019). The reversal of sarcopenia was associated with clinically relevant improvements in the FACT-An (11.7 points [95 % confidence interval (CI) -4.2 to 27.6]), the Trial Outcome Index-Anemia (10.0 points [95 % CI -4.0 to 24.1]), and fatigue (5.3 points [95 % CI -1.5 to 12.1]). Early-stage BC patients initiating adjuvant chemotherapy have higher than expected rates of sarcopenia and dynapenia which are associated with poorer QoL. RET during adjuvant chemotherapy resulted in the reversal of both sarcopenia and dynapenia; however, only the reversal of sarcopenia was associated with clinically meaningful improvements in QoL. PMID:27394134

  4. Prospective study of cognitive function in children receiving whole-brain radiotherapy and chemotherapy: 2-year results

    International Nuclear Information System (INIS)

    As survival rates have risen for children with malignant primary brain tumors, so has the concern that many survivors have significant permanent cognitive deficits. Cranial irradiation (CRT) has been implicated as the major cause for cognitive dysfunction. To clarify the etiology, incidence, and severity of intellectual compromise in children with brain tumors after CRT, a prospective study was undertaken comparing the neuropsychological outcome in 18 consecutive children with malignant brain tumors treated with CRT to outcome in 14 children harboring brain tumors in similar sites in the nervous system who had not received CRT. Children with cortical or subcortical brain tumors were not eligible for study. Neuropsychological testing was performed after surgery prior to radiotherapy, after radiotherapy, and at 1- and 2-year intervals thereafter. Children who had received CRT had a mean full-scale intelligence quotient (FSIQ) of 105 at diagnosis which fell to 91 by Year 2. Similar declines were noted in their performance intelligence quotient (IQ) and verbal IQ. After CRT, patients demonstrated a statistically significant decline from baseline in FSIQ (p less than 0.02) and verbal IQ (p less than 0.04). Children who had not received CRT did not demonstrate a fall in any cognitive parameter over time. The decline between baseline testing and testing performed at Year 2 in patients who had CRT was inversely correlated with age (p less than 0.02), as younger children demonstrated the greatest loss of intelligence. Children less than 7 years of age at diagnosis had a mean decline in FSIQ of 25 points 2 years posttreatment. No other clinical parameter correlated with the overall IQ or decline in IQ. After CRT, children demonstrated a wide range of dysfunction including deficits in fine motor, visual-motor, and visual-spatial skills and memory difficulties

  5. Prospective Study of Functional Bone Marrow-Sparing Intensity Modulated Radiation Therapy With Concurrent Chemotherapy for Pelvic Malignancies

    Energy Technology Data Exchange (ETDEWEB)

    Liang Yun [Department of Radiation Oncology, University of California, San Diego, La Jolla, California (United States); Center for Advanced Radiotherapy Technologies, University of California, San Diego, La Jolla, California (United States); Bydder, Mark [Department of Radiology, University of California, San Diego, La Jolla, California (United States); Yashar, Catheryn M.; Rose, Brent S. [Department of Radiation Oncology, University of California, San Diego, La Jolla, California (United States); Center for Advanced Radiotherapy Technologies, University of California, San Diego, La Jolla, California (United States); Cornell, Mariel [Department of Radiation Oncology, University of California, San Diego, La Jolla, California (United States); Hoh, Carl K. [Department of Radiology, University of California, San Diego, La Jolla, California (United States); Lawson, Joshua D. [Department of Radiation Oncology, University of California, San Diego, La Jolla, California (United States); Center for Advanced Radiotherapy Technologies, University of California, San Diego, La Jolla, California (United States); Einck, John [Department of Radiation Oncology, University of California, San Diego, La Jolla, California (United States); Saenz, Cheryl [Department of Gynecologic Oncology, University of California, San Diego, La Jolla, California (United States); Fanta, Paul [Division of Hematology-Oncology, University of California, San Diego, La Jolla, California (United States); Mundt, Arno J. [Department of Radiation Oncology, University of California, San Diego, La Jolla, California (United States); Center for Advanced Radiotherapy Technologies, University of California, San Diego, La Jolla, California (United States); Bydder, Graeme M. [Department of Radiology, University of California, San Diego, La Jolla, California (United States); and others

    2013-02-01

    Purpose: To test the hypothesis that intensity modulated radiation therapy (IMRT) can reduce radiation dose to functional bone marrow (BM) in patients with pelvic malignancies (phase IA) and estimate the clinical feasibility and acute toxicity associated with this technique (phase IB). Methods and Materials: We enrolled 31 subjects (19 with gynecologic cancer and 12 with anal cancer) in an institutional review board-approved prospective trial (6 in the pilot study, 10 in phase IA, and 15 in phase IB). The mean age was 52 years; 8 of 31 patients (26%) were men. Twenty-one subjects completed {sup 18}F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) simulation and magnetic resonance imaging by use of quantitative IDEAL (IDEAL IQ; GE Healthcare, Waukesha, WI). The PET/CT and IDEAL IQ were registered, and BM subvolumes were segmented above the mean standardized uptake value and below the mean fat fraction within the pelvis and lumbar spine; their intersection was designated as functional BM for IMRT planning. Functional BM-sparing vs total BM-sparing IMRT plans were compared in 12 subjects; 10 were treated with functional BM-sparing pelvic IMRT per protocol. Results: In gynecologic cancer patients, the mean functional BM V{sub 10} (volume receiving {>=}10 Gy) and V{sub 20} (volume receiving {>=}20 Gy) were 85% vs 94% (P<.0001) and 70% vs 82% (P<.0001), respectively, for functional BM-sparing IMRT vs total BM-sparing IMRT. In anal cancer patients, the corresponding values were 75% vs 77% (P=.06) and 62% vs 67% (P=.002), respectively. Of 10 subjects treated with functional BM-sparing pelvic IMRT, 3 (30%) had acute grade 3 hematologic toxicity or greater. Conclusions: IMRT can reduce dose to BM subregions identified by {sup 18}F-fluorodeoxyglucose-PET/CT and IDEAL IQ. The efficacy of BM-sparing IMRT is being tested in a phase II trial.

  6. Treatment of Children With Central Nervous System Primitive Neuroectodermal Tumors/Pinealoblastomas in the Prospective Multicentric Trial HIT 2000 Using Hyperfractionated Radiation Therapy Followed by Maintenance Chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Gerber, Nicolas U., E-mail: nicolas.gerber@kispi.uzh.ch [Department of Pediatric Oncology, University Children' s Hospital, Zurich (Switzerland); Hoff, Katja von; Resch, Anika [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Ottensmeier, Holger [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Kwiecien, Robert; Faldum, Andreas [Institute of Biostatistics and Clinical Research, University of Muenster (Germany); Matuschek, Christiane [Department of Radiation Oncology, Medical Faculty, Heinrich Heine University of Duesseldorf, Duesseldorf (Germany); Hornung, Dagmar [Department of Radiotherapy and Radio-Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Bremer, Michael [Institute for Radiation Therapy and Special Oncology, Hannover Medical School, Hannover (Germany); Benesch, Martin [Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz (Austria); Pietsch, Torsten [Department of Neuropathology, University of Bonn, Bonn (Germany); Warmuth-Metz, Monika [Department of Neuroradiology, University of Wuerzburg, Wuerzburg (Germany); Kuehl, Joachim [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Rutkowski, Stefan [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Kortmann, Rolf D. [Department of Radiation Oncology, University of Leipzig, Leipzig (Germany)

    2014-07-15

    Purpose: The prognosis for children with central nervous system primitive neuroectodermal tumor (CNS-PNET) or pinealoblastoma is still unsatisfactory. Here we report the results of patients between 4 and 21 years of age with nonmetastatic CNS-PNET or pinealoblastoma diagnosed from January 2001 to December 2005 and treated in the prospective GPOH-trial P-HIT 2000-AB4. Methods and Materials: After surgery, children received hyperfractionated radiation therapy (36 Gy to the craniospinal axis, 68 Gy to the tumor region, and 72 Gy to any residual tumor, fractionated at 2 × 1 Gy per day 5 days per week) accompanied by weekly intravenous administration of vincristine and followed by 8 cycles of maintenance chemotherapy (lomustine, cisplatin, and vincristine). Results: Twenty-six patients (15 with CNS-PNET; 11 with pinealoblastoma) were included. Median age at diagnosis was 11.5 years old (range, 4.0-20.7 years). Gross total tumor resection was achieved in 6 and partial resection in 16 patients (indistinct, 4 patients). Median follow-up of the 15 surviving patients was 7.0 years (range, 5.2-10.0 years). The combined response rate to postoperative therapy was 17 of 20 (85%). Eleven of 26 patients (42%; 7 of 15 with CNS-PNET; 4 of 11 with pinealoblastoma) showed tumor progression or relapse at a median time of 1.3 years (range, 0.5-1.9 years). Five-year progression-free and overall survival rates (±standard error [SE]) were each 58% (±10%) for the entire cohort: CNS-PNET was 53% (±13); pinealoblastoma was 64% (±15%; P=.524 and P=.627, respectively). Conclusions: Postoperative hyperfractionated radiation therapy with local dose escalation followed by maintenance chemotherapy was feasible without major acute toxicity. Survival rates are comparable to those of a few other recent studies but superior to those of most other series, including the previous trial, HIT 1991.

  7. NSCLC: primary tumor size - radiation dose-related accelerated, twice daily radiotherapy by target splitting, preceded by 2 cycles of chemotherapy. First results of a prospective study

    International Nuclear Information System (INIS)

    Ensuing a phase I trial of accelerated, twice daily high dose radiotherapy showing good tolerability, a prospective study relating primary tumor size with radiation dose in non-operated patients with non-small cell lung cancer (NSCLC) was started. From 01/2004 until 12/2006 79 patients with 81 histologically/cytologically proven NSCLC tumors were treated, representing 94% of all referred non-operated NSCLC patients in stage Mo, malignant pleural effusions excluded. For the majority of patients the conformal target splitting technique has been employed. The target is split into a cranial and a caudal part; beam arrangements in the two parts are completely independent. In order to reduce internal margins slow planning CTs (4 sec./slice) were used, patients freely breathing, 7 mm margins from gross tumor volume to planning target volume. We formed 4 groups with primary tumor sizes (mean number of 3 perpendicular diameters) 6,0 cm (11/41/22/7 patients, respectively); tumor doses of 73,8, 79,2, 84,6 and 90,0 Gy (ICRU) were applied to the primary tumors of the patients in the respective groups. Single dose 1,8 Gy; twice daily, interval 11 h; 5 days/week; duration 33 days median (range 29-42). Macroscopically involved nodes 61,2 Gy median (range 54,0-75,6 Gy), nodes electively 45,0 Gy (to volume about 6 cm cranial to apparently involved nodes). In 62 patients chemotherapy before radiotherapy was given, 2 cycles median, generally a cisplatin or carboplatin containing doublet; no concurrent chemotherapy. Median follow-up of all patients 16,7 months, of patients alive 19,3 months. Until now 10 local failures (0/11, 3/41, 5/22, 2/7 in the respective groups) and 2 regional failures occured, resulting in an actuarial local and regional tumor control of 80,1% and 96% at 2 years, respectively. Local failures relate to the primary tumor site, regional failures to the regional node sites. Overall actuarial 1-, 2-year survival rate for all patients: 76%, 56%, respectively, median 26

  8. Treatment of Children With Central Nervous System Primitive Neuroectodermal Tumors/Pinealoblastomas in the Prospective Multicentric Trial HIT 2000 Using Hyperfractionated Radiation Therapy Followed by Maintenance Chemotherapy

    International Nuclear Information System (INIS)

    Purpose: The prognosis for children with central nervous system primitive neuroectodermal tumor (CNS-PNET) or pinealoblastoma is still unsatisfactory. Here we report the results of patients between 4 and 21 years of age with nonmetastatic CNS-PNET or pinealoblastoma diagnosed from January 2001 to December 2005 and treated in the prospective GPOH-trial P-HIT 2000-AB4. Methods and Materials: After surgery, children received hyperfractionated radiation therapy (36 Gy to the craniospinal axis, 68 Gy to the tumor region, and 72 Gy to any residual tumor, fractionated at 2 × 1 Gy per day 5 days per week) accompanied by weekly intravenous administration of vincristine and followed by 8 cycles of maintenance chemotherapy (lomustine, cisplatin, and vincristine). Results: Twenty-six patients (15 with CNS-PNET; 11 with pinealoblastoma) were included. Median age at diagnosis was 11.5 years old (range, 4.0-20.7 years). Gross total tumor resection was achieved in 6 and partial resection in 16 patients (indistinct, 4 patients). Median follow-up of the 15 surviving patients was 7.0 years (range, 5.2-10.0 years). The combined response rate to postoperative therapy was 17 of 20 (85%). Eleven of 26 patients (42%; 7 of 15 with CNS-PNET; 4 of 11 with pinealoblastoma) showed tumor progression or relapse at a median time of 1.3 years (range, 0.5-1.9 years). Five-year progression-free and overall survival rates (±standard error [SE]) were each 58% (±10%) for the entire cohort: CNS-PNET was 53% (±13); pinealoblastoma was 64% (±15%; P=.524 and P=.627, respectively). Conclusions: Postoperative hyperfractionated radiation therapy with local dose escalation followed by maintenance chemotherapy was feasible without major acute toxicity. Survival rates are comparable to those of a few other recent studies but superior to those of most other series, including the previous trial, HIT 1991

  9. Effects on the hemostatic system and liver function in relation to Implanon and Norplant. A prospective randomized clinical trial.

    Science.gov (United States)

    Egberg, N; van Beek, A; Gunnervik, C; Hulkko, S; Hirvonen, E; Larsson-Cohn, U; Bennink, H C

    1998-08-01

    In this prospective randomized clinical trial, two long-term contraceptive implants were studied with respect to hemostasis and liver function in 86 healthy young women. The two implants used were Implanon, containing the progestagen etonogestrel (the biologically active metabolite of desogestrel) and Norplant, the implant containing the progestagen levonorgestrel. The results of the trial showed that both implants had similar small effects on the hemostatic system that are not suggestive of a tendency towards thrombosis. The effect on liver function was characterized by increases in total bilirubin and gamma-glutamyl transferase and decreases in alanine aminotransferase and aspartate aminotransferase. PMID:9773263

  10. A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

    Directory of Open Access Journals (Sweden)

    Endlicher Esther

    2009-01-01

    Full Text Available Abstract Background Pancreatic cancer is the fourth most common cause of cancer related death in Western countries. Advantages in surgical techniques, radiation and chemotherapy had almost no impact on the long term survival of affected patients. Therefore, the need for better treatment strategies is urgent. HER2, a receptor tyrosine kinase of the EGFR family, involved in signal transduction pathways leading to cell growth and differentiation is overexpressed in a number of cancers, including breast and pancreatic cancer. While in breast cancer HER2 has already been successfully used as a treatment target, there are only limited data evaluating the effects of inhibiting HER2 tyrosine kinases in patients with pancreatic cancer. Methods Here we report the design of a prospective, non-randomized multi-centered Phase II clinical study evaluating the effects of the Fluoropyrimidine-carbamate Capecitabine (Xeloda ® and the monoclonal anti-HER2 antibody Trastuzumab (Herceptin® in patients with non-resectable, HER2 overexpressing pancreatic cancer. Patients eligible for the study will receive Trastuzumab infusions on day 1, 8 and 15 concomitant to the oral intake of Capecitabine from day 1 to day 14 of each three week cylce. Cycles will be repeated until tumor progression. A total of 37 patients will be enrolled with an interim analysis after 23 patients. Discussion Primary end point of the study is to determine the progression free survival after 12 weeks of bimodal treatment with the chemotherapeutic agent Capecitabine and the anti-HER2 antibody Trastuzumab. Secondary end points include patient's survival, toxicity analysis, quality of life, the correlation of HER2 overexpression and clinical response to Trastuzumab treatment and, finally, the correlation of CA19-9 plasma levels and progression free intervals.

  11. Brachytherapy boost in loco-regionally advanced nasopharyngeal carcinoma: a prospective randomized trial of the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    The purpose was to determine whether a brachytherapy boost improves outcomes in patients with advanced nasopharyngeal carcinoma treated with standard chemo-radiotherapy. Patients with nasopharyngeal carcinoma WHO grades I-III and TNM stages III or non-metastatic stage IV were eligible for this phase III study. Patients were randomized to either arm (A) induction chemotherapy, followed by external beam radiotherapy (EBRT) with concomitant cisplatin (n = 139) or arm (B), the same schedule plus a brachytherapy boost to the nasopharynx (n = 135). The EBRT doses given were 70 Gy to the primary tumour and positive lymph nodes and 46 Gy to the negative neck. The additional brachytherapy boost in arm (B) was given by either low dose-rate (LDR – 11 Gy) or high dose-rate (HDR – 3 fractions of 3.0 Gy) brachytherapy. The primary endpoint was 3-year overall survival (OS) and secondary endpoints were: local control, regional control, distant metastasis and grade 3–4 adverse events. 274 patients were randomized between September 2004 and December 2008. The two arms were comparable with regard to age, gender, stage and grade. 273 patients completed treatment. Median follow-up was 29 months (0.2-67 months). The effect of treatment arm, country, age, gender, WHO pathology, stage (T3-4, N2-3 versus other) and chemotherapy on overall survival (OS), disease-free survival (DFS) and local recurrence-free survival (LRFS) was studied. Stage significantly affected OS (p = 0.024) and DFS (p = 0.018) while age significantly affected OS (p = 0.014). None of the other factors studied were significant. The 3-year LRFS was 60.5% and 54.4% in arms A and B respectively (p = 0.647). The 3-year regional control rate in the neck was 59.7% and 54.3% respectively (p = 0.7). Distant metastasis developed in 59.7% of patients in arm A and 55.4% in arm B (p = 0.377). Patients with T1/T2 N + had a 3 year LRFS of 51.8% in Arm A (62 patients) versus 57.9% in Arm B (67 patients) (p = 0.343). The grade 3

  12. Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone

    OpenAIRE

    Tröger, Wilfried; Jezdić, Svetlana; Ždrale, Zdravko; Tišma, Nevena; Hamre, Harald J; Matijašević, Miodrag

    2009-01-01

    Background: Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia. Pati...

  13. Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone

    OpenAIRE

    Wilfried Tröger; Svetlana Jezdić; Zdravko Ždrale; Nevena Tišma; Hamre, Harald J; Miodrag Matijašević

    2009-01-01

    Background: Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia.Patie...

  14. The International Atomic Energy Agency (IAEA) randomized trial of palliative treatment of incurable locally advanced non small cell lung cancer (NSCLC) using radiotherapy (RT) and chemotherapy (CHT) in limited resource setting

    International Nuclear Information System (INIS)

    Background: To optimize palliation in incurable locally advanced non-small cell lung cancer (NSCLC), the International Atomic Energy Agency conducted a prospective randomized study (NCT00864331) comparing protracted palliative radiotherapy (RT) course with chemotherapy (CHT) followed by short-course palliative RT. Methods and materials: Treatment-naive patients with histologically confirmed NSCLC, stage IIIA/IIIB, received either 39 Gy in 13 fractions as RT alone (arm A, n = 31) or 2–3 platinum-based CHT cycles followed by 10 Gy in a single fraction or 16 Gy in 2 fractions separated by one week (arm B, n = 34). Primary outcome was overall survival. Results: Treatment groups were balanced with respect to various variables. Median survival for all 65 patients was 8 months, while median survival was 7.1 and 8.1 months for the two arms, respectively (log-rank p = 0.4 by study arm, and p = 0.6 by Cox regression and stratified by country and sub-stage). One and three year survival rates for the two arms were 29%, and 9% and 41%, and 6%, respectively. There were no differences in any of the following endpoints: any failure, local failure, regional failure, contralateral thoracic failure, and distant failure between the two arms. High-grade (⩾3) toxicity was similar between the two arms. Symptoms, adverse events of any kind, KPS and body-mass index, were not different during treatment and during follow-up. There was no grade 5 toxicity. Conclusions: This incomplete and underpowered trial only hinted similar outcome between the treatment arms. Therefore, combined CHT-RT can perhaps be considered, in limited resource setting, where access to RT remains inadequate

  15. A Randomized study on the Effects of Paclitaxel Liposme and Cisplatin Induction Chemotherapy Followed Concurrent Chemoradiotherapy and Sequential Radiotherapy on Locally Advanced Non-small Cell Lung Cancer Patients

    Directory of Open Access Journals (Sweden)

    Youyi DAI

    2011-02-01

    Full Text Available Background and objective Sequential and concurrent chemoradiotherapy were widely studied in locally advanced non-small cell lung cancer (NSCLC, but the reports of induction chemotherapy followed concurrent chemoradiotherapy are rare so far. The little side effects of paclitaxel liposme may be convenient to carry out induction chemotherapy followed concurrent chemoradiotherapy. The aim of this study is to compare the effects and side effects of TP regimen (Paclitaxel liposme and cisplatin induction chemotherapy followed concurrent chemoradiotherapy with sequential radiotherapy on locally advanced NSCLC. Methods Sixty locally advanced NSCLC patients were randomly divided into group A, induction chemotherapy followed concurrent chemoradiotherapy and group B, sequential radiotherapy group. The patients in group A received 2-3 cycles of induced chemotherapy included of Paclitaxel liposme 135 mg/m2-175 mg/m2, d1 and cisplatin 70 mg/m2-80 mg/m2, d2, 3 weeks repeat and after 2-3 cycles followed by concurrent chemoradiotherapy. The patients in group B received chemotherapy, (as described above in group A 4-6 cycles of chemotherapy followed one cycle of radiotherapy. The three-dimensional conformal radiotherapy at the total dose of 56 Gy-70 Gy was applied in all patients. Results The response rate in group A and group B were 80.3% and 60%, respectively (P=0.042. 1-year survival rates were 71.4% and 53.2%, respectively (P=0.18. And there were no significant difference of myelosuppression, radiation esophagitis and pulmonary fibrosis between the two groups (P=0.09, P=0.147, P=0.276, respectively. Conclusion The recent effects of induction chemotherapy followed by concurrent chemoradiotherapy group were better than sequential radiotherapy group on locally advanced NSCLC and there was no significant difference in side effects between the two groups.

  16. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    Science.gov (United States)

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today. PMID:24451886

  17. Cancer Chemotherapy

    Science.gov (United States)

    ... controlled way. Cancer cells keep growing without control. Chemotherapy is drug therapy for cancer. It works by killing the cancer ... It depends on the type and amount of chemotherapy you get and how your body reacts. Some ...

  18. Cancer Chemotherapy

    Science.gov (United States)

    ... cells grow and die in a controlled way. Cancer cells keep forming without control. Chemotherapy is drug ... Your course of therapy will depend on the cancer type, the chemotherapy drugs used, the treatment goal ...

  19. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  20. Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial

    DEFF Research Database (Denmark)

    Stein, A.; Arnold, D.; Bridgewater, J.;

    2015-01-01

    Background: Despite complete resection, disease-free survival (DFS) of patients with cholangiocarcinoma (CCA) is less than 65 % after one year and not more than 35 % after three years. For muscle invasive gallbladder carcinoma (GBCA), prognosis is even worse, with an overall survival (OS) of only...... endpoint is DFS and secondary endpoints include OS, safety and tolerability of chemotherapy, quality of life, and patterns of disease recurrence. For CCA, adjuvant chemotherapy should increase DFS 24 months post-surgery from 40 to 55 % to be considered relevant. With a power of 80 % and a significance...... both cohorts, randomization will be 1: 1 with chemotherapy for 24 weeks and imaging every twelve weeks. In 2014, the study was initiated in Germany and in The Netherlands (funded by the Deutsche Krebshilfe, the Dutch Cancer Society, and supported by medac GmbH). Sites in Australia, Denmark, and the...

  1. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    Institute of Scientific and Technical Information of China (English)

    Elena Ricart; Maria Esteve; Montserrat Andreu; Francesc Casellas; David Monfort; Miquel Sans; Natalia Oudovenko; Raúl Lafuente; Julián Panés

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis.METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and L1 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases.Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported.CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.

  2. Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial

    Directory of Open Access Journals (Sweden)

    Pérol David

    2012-12-01

    Full Text Available Abstract Background Chemotherapy induced nausea and vomiting (CINV remains a major problem that seriously impairs the quality of life (QoL in cancer patients receiving chemotherapy regimens. Complementary medicines, including homeopathy, are used by many patients with cancer, usually alongside with conventional treatment. A randomized, placebo-controlled Phase III study was conducted to evaluate the efficacy of a complex homeopathic medicine, Cocculine, in the control of CINV in non-metastatic breast cancer patients treated by standard chemotherapy regimens. Methods Chemotherapy-naïve patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100 or TAC were randomized to receive standard anti-emetic treatment plus either a complex homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness or the matching placebo (NCT00409071 clinicaltrials.gov. The primary endpoint was nausea score measured after the 1st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA and investigator recording (NCI-CTC AE V3.0 and treatment compliance. Results From September 2005 to January 2008, 431 patients were randomized: 214 to Cocculine (C and 217 to placebo (P. Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms had nausea FLIE scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility

  3. Benefit and risk of primary thromboprophylaxis in ambulatory patients with advanced pancreatic cancer receiving chemotherapy: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Tun, Nay Min; Guevara, Elizabeth; Oo, Thein Hlaing

    2016-04-01

    As vascular thromboembolism (VTE) is a leading cause of death in cancer patients, it has been postulated that primary thromboprophylaxis (PTP) in cancer patients might improve survival by reducing VTE occurrence. We performed a systemic review and meta-analysis of randomized controlled trials (RCTs) to investigate the benefit and risk of PTP with low-molecular-weight heparins (LMWHs) in ambulatory advanced pancreatic cancer (APC) patients receiving chemotherapy. We undertook a literature search using MEDLINE and EMBASE databases through May 2015. RCTs with reduction in symptomatic VTE as a primary or secondary endpoints were included. Mantel-Haenszel method was used to estimate the pooled event-based risk ratio as well as the pooled absolute risk difference with 95% confidence interval (CI). Seven hundred and thirty-eight APC patients were eligible for analysis. PTP lasted 3-6 months. The crude VTE incidence was 2.1 and 11.2% in LMWH and in control groups, respectively (risk ratio, 0.18; 95% CI, 0.083-0.39; P questions. PMID:26963028

  4. Scandinavian Prospects for a Place-Based Randomized Experiment on Burglary Reduction

    DEFF Research Database (Denmark)

    Sorensen, David Woodrow Mattson

    2007-01-01

    Despite their widespread implementation, there is a surprising absence of clear-cut, unambiguous evidence concerning the effectiveness of situational crime prevention approaches (e.g. alarms, neighborhood watch, property-marking) on residential burglary. This absence of evidence - which should no......-based, randomized experimental design - which this author argues should be easier to implement in Scandinavia than elsewhere....

  5. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R;

    2002-01-01

    BACKGROUND: Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy. METHODS: In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic...

  6. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  7. Unipedicular versus bipedicular percutaneous vertebroplasty for osteoporotic vertebral compression fractures: a prospective randomized study

    OpenAIRE

    Zhang, Liang; Liu, Zhongjun; Wang, Jingcheng; Feng, Xinmin; Yang, Jiandong; Tao, Yuping; Zhang, Shengfei

    2015-01-01

    Background Percutaneous vertebroplasty (PVP) typically involves conventional lower-viscosity cement injection via bipedicular approach. Limited evidence is available comparing the clinical outcomes and complications in treating osteoporotic vertebral compression fractures (OVCFs) with PVP using high-viscosity cement through unipedicular or bipedicular approach. Methods and design Fifty patients with OVCFs were randomly allocated into two groups adopting unipedicular or bipedicular PVP. The ef...

  8. Prospects for a Quantum Dynamic Random Access Memory (Q-DRAM)

    CERN Document Server

    Bandyopadhyay, S

    2001-01-01

    Compared to quantum logic gates, quantum memory has received far less attention. Here, we explore the prognosis for a solid-state, scalable quantum dynamic random access memory (Q-DRAM), where the qubits are encoded by the spin orientations of single quantons in exchange-decoupled quantum dots. We address, in particular, various possibilities for implementing refresh cycles.

  9. Prospective Multicenter Randomized Phase III Study of Weekly versus Standard Docetaxel (D2) for First-Line Treatment of Metastatic Breast Cancer

    OpenAIRE

    Stemmler, Hans-Joachim; Harbeck, Nadia; de Rivera, Isolde Groell; Kaiser, Ursula Vehling; Rauthe, Gerhard; Abenhardt, Wolfgang; Artmann, Almut; Sommer, Harald; Meerpohl, Hans-Gerd; Kiechle, Marion; Heinemann, Volker

    2010-01-01

    Purpose: Previous phase II studies have indicated a greatly reduced hematotoxicity of docetaxel-based regimens administered on weekly schedules. The present trial was initiated to randomly compare the toxicity and efficacy of weekly docetaxel versus its standard 3-weekly application. Methods: Patients previously untreated with chemotherapy for metastatic disease were recruited. Patients aged >60 years or with a Karnofsky Perfomance Status (KPS) of 60-80% were eligible for the D2 study. Patien...

  10. Radiochemotherapy of locally advanced anal canal carcinoma: Prospective assessment of early impact on the quality of life (randomized trial ACCORD 03)

    International Nuclear Information System (INIS)

    Background and purpose: The aim of this study was to prospectively assess the quality of life (QOL) of patients treated by concomitant chemo radiation for locally advanced anal canal carcinoma. Materials and methods: We report on a subgroup of 119 patients enrolled in a 306-patient therapeutic intensification prospective trial (ACCORD 03). This trial evaluated the impact on colostomy-free survival of induction chemotherapy and/or high dose radiotherapy (factorial design 2 * 2 treatment arms). QOL was assessed both before and 2 months after treatment using the EORTC QLQ-C30 questionnaire as well as a questionnaire relating to anal sphincter conservative treatment (AS-CT). Results: Compared to pre-treatment scores, patients reported significant improvement in their emotional function (+8.4 points p = 0.002), global health status (+5.9 points p = 0.0007), as well as a decrease in insomnia (-13.8 points p < 0.0001), constipation (-12.0 points p < 0.0001), appetite loss (-10.3 points p < 0.0001) and pain (-9.6 points p = 0.0002). The AS-CT degree of satisfaction with intestinal functions score was increased (+11.2 points p < 0.0001). Conclusion: This is the first prospective study comparing QOL of patients with advanced anal canal carcinoma, before and 2 months after conservative treatment. Two months after treatment, QOL was improved. Induction chemotherapy and/or high dose radiotherapy did not provide a negative impact on QOL

  11. A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

    Science.gov (United States)

    Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

    2007-09-01

    Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base. PMID:18632524

  12. A Phase II prospective nonrandomized trial of magnetic resonance imaging-guided hematopoietic bone marrow-sparing radiotherapy for gastric cancer patients with concurrent chemotherapy

    Directory of Open Access Journals (Sweden)

    Wang J

    2016-05-01

    Full Text Available Jianyang Wang, Yuan Tian, Yuan Tangm, Xin Wang, Ning Li, Hua Ren, Hui Fang, Yanru Feng, Shulian Wang, Yongwen Song, Yueping Liu, Weihu Wang, Yexiong Li, Jing Jin Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People’s Republic of China Purpose: This study aimed to spare hematopoietical bone marrow (BM identified by magnetic resonance (MR radiation in order to alleviate acute hematologic toxicity (HT for gastric cancer patients treated with postoperative chemoradiotherapy (CRT.Methods: A prospective, open-label, single-arm Phase II study (Clinicaltrials.gov; NCT 01863420 was conducted in 25 patients with gastric cancer who were eligible for postoperative concurrent CRT. The MR images of vertebral body T8-L4 were fused with images of simulating computed tomography. Hematopoietical BM was contoured according to the MR and spared in radiotherapy plan. The CRT regimen consisted of daily capecitabine (1600 mg/m2/d and 45 Gy of radiation at 1.8 Gy per day. Primary endpoints were grade ≥3 HT that occurred within 2 months of initiation of CRT. The relationship between HT and dose–volume of BM was estimated by multivariable linear regression model.Results: Twenty four patients (96% had T3–4 disease and 22 (88% had disease with node positive. The median age was 53 years (range, 28–73 years. Before concurrent CRT, adjuvant chemotherapy was administered with a mean cycle of 4.3±0.5. Only five patients (20% developed grade 3–4 HT during treatment, among whom two (8.0% patients experienced grade 3–4 leucopenia, two (8.0% experienced neutropenia, and two (8.0% experienced thrombocytopenia, respectively. None of the patients showed grade 3–4 anemia. Multivariable linear regression revealed increased BM-V5 (P=0.03 and BM-V20 (P=0.002 were found to be significantly associated with decreased white blood cells nadirs in multivariable regression

  13. Acetaminophen and diphenhydramine as premedication for platelet transfusions: a prospective randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Wang, Stephen E; Lara, Primo N; Lee-Ow, Angie; Reed, Jeanne; Wang, Lori R; Palmer, Patti; Tuscano, Joseph M; Richman, Carol M; Beckett, Laurel; Wun, Ted

    2002-07-01

    Non-hemolytic transfusion reactions (NHTR) occur in up to 30% of patients receiving platelet transfusions. Premedication with acetaminophen and diphenhydramine is a common strategy to prevent NHTR, but its efficacy has not been studied. In this prospective trial, transfusions in patients receiving pre-storage leukocyte-reduced single-donor apheresis platelets (SDP) were randomized to premedication with either acetaminophen 650 mg PO and diphenhydramine 25 mg IV, or placebo. Fifty-one patients received 98 transfusions. Thirteen patients had 15 NHTR: 15.4% (8/52) in the treatment arm and 15.2% (7/46) in the placebo arm. Premedication prior to transfusion of pre-storage leukocyte reduced SDP does not significantly lower the incidence of NHTR as compared to placebo. PMID:12111764

  14. Influence of the pneumatic tourniquet on patella tracking in total knee arthroplasty: a prospective randomized study in 100 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Toftgaard Jensen, T

    2005-01-01

    One hundred consecutive patients with osteoarthritis of the knee joint and scheduled for primary total knee arthroplasty performed in a bloodless field were prospectively randomized to have the tourniquet inflated on either straight leg or maximally flexed knee. There was no difference in the...... number of lateral releases between the groups, and position of the knee in maximal flexion during inflation of the tourniquet did not decrease the number of lateral releases. There was no difference in clinical or radiological patella tracking between groups. If the patella was maltracking, tourniquet...... deflation led to better patella tracking and saved 5 (31%) of 16 releases with no difference between groups. We recommend tourniquet deflation and reevaluation of patella tracking before performing lateral release in patellar maltracking....

  15. Study of consolidation chemotherapy in advanced epithelial ovarian carcinoma

    Institute of Scientific and Technical Information of China (English)

    Cheng Ning-hai; Huang Hui-fang; Pan Lin-ya; Shen Keng; Wu Ming; Yang Jia-xin

    2007-01-01

    Objective: A prospective randomized study was designed to evaluate the role of consolidation chemotherapy in advanced epithelial ovarian carcinoma.Methods: 50 patients with advanced epithelial ovarian carcinoma treated in our hospital during the period from March 2000 to October 2005 were enrolled in this study.All patients had achieved clinical complete remission by means of standard treatments, and were randomly divided into consolidation chemotherapy group and control group.Relapse rate, and disease-free survival(DFS) time were analyzed in both groups.Results: 24 patients were assigned in consolidation chemotherapy group, and 26 patients in control group.Tumor relapse interval in consolidation group was (26.5±7.4) months, vs.(16.8±7.0) months in control group respectively, P=0.001.Time to relapse(TTR) in consolidation group was (19.2±6.8) months, vs.(10.0±6.9)months in control group, P=0.002.Analysis of DFS time and overall survival time, Log Rank test:P=0.042 and P= 0.062, respectively.Conclusions: Consolidation chemotherapy could be the relevant factor that postpones tumor relapse interval and prolongs DFS time in advanced epithelial ovarian carcinoma patients who had achived chlinical complete remission.But so far the statistic result of our clinical study is beyond the conclusion that consolidation chemotherapy can decrease relapse rate or increase survival rate.Muhicenter randomized clinical trial should be performed to confirm the role of consolidation chemotherapy in advanced epithelial ovarian carcinoma.

  16. Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

    International Nuclear Information System (INIS)

    Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

  17. Early ambulation following 6 French diagnostic left heart catheterization: a prospective randomized trial.

    Science.gov (United States)

    Wood, R A; Lewis, B K; Harber, D R; Kovack, P J; Bates, E R; Stomel, R J

    1997-09-01

    Outpatient cardiac catheterization is frequently performed, but the optimal recovery time after sheath removal has not been defined. Left heart catheterization was performed via the femoral artery utilizing 6 French catheters on 323 outpatients. One hundred thirty-five patients were randomized to ambulate at a mean of 2.5 hr (group 1) after puncture site compression, whereas 188 patients were randomized to ambulate at a mean of 4.1 hr (group 2). Telephone follow-up occurred within 48 hr. A small hematoma (< 5 cm) occurred in 2 (1.6%) patients in group 1 and in 4 (2.4%) patients in group 2. These results indicate that it is safe to ambulate patients 2.5 hr following 6 French diagnostic heart catheterization. PMID:9286529

  18. Comparing docetaxel with gemcitabine as second-line chemotherapy in patients with advanced non-small cell lung cancer: A single institute randomized phase II study

    Directory of Open Access Journals (Sweden)

    Khosravi A

    2015-01-01

    Full Text Available Background: Platinum-based doublet chemotherapy is the backbone of treatment in advanced non-small cell lung cancer (NSCLC however second-line treatment options are controversial particularly in patients with borderline performance status (PS of 2. The aim of this study was to compare efficacy and toxicity of weekly docetaxel versus gemcitabine in this clinical setting. Patients and methods: A total of 70 patients with advanced (stage IIIB, IV NSCLC entered this single institute study. Cases of this study had experienced disease progression after the first-line platinum-based doublet chemotherapy, with PS 0- 2 in “Eastern Cooperative Oncology Group” scale. They were randomly assigned by stratified blocks to receive docetaxel 35 mg/m2 (Arm A, n=34 or gemcitabine 1000 mg/m2 (Arm B, n=36 days 1, 8 and 15, every three weeks, for up to six cycles. Primary end point was progression free survival (PFS and secondary end points were objective response rate, disease control rate, median overall survival (OS and toxicity. Dose modification was permitted upon clinician’s discretion for each individual patient. Results: Median of PFS was 2.02 months in arm A and 2.63 months in arm B (HR= 1.279; 95% CI: 0.710-2.304, P= 0.551. Although median OS for arm A was numerically greater (9.2 months than arm B (8.3 months it was statistically non-significant (HR= 1.384; 95% CI: 0.632 to 2.809, P= 0.59. Objective response was higher in Arm B than that in Arm A (P= 0.20 but disease control rates were statistically different in both arms (P= 0.034. Statistically significant differences in term of leukopenia was seen in arm B (P= 0.013. Conclusion: This study, with limited number of cases, indicates that in advanced NSCLC, weekly docetaxel and gemcitabine are reasonable second-line treatment options with statistically similar effectiveness in terms of PFS and median OS with manageable toxicities in patients with PS 0-2.

  19. Effect of Topical Tetracycline on Seroma Formation in the Lichtenstein Technique: A Prospective Randomized Study

    OpenAIRE

    Turk, Emin; Karagulle, Erdal; Coban, Gokcen; YILDIRIM, Erkan; Moray, Gokhan

    2014-01-01

    We sought to investigate whether application of topical tetracycline has a limiting effect on seroma formation in patients undergoing hernia repair using a polypropylene mesh. This study was conducted in 96 patients undergoing an elective groin hernia repair. Patients were randomized and divided into 2 groups. After the graft was placed, and before external oblique muscle aponeurosis was closed, 5 mL tetracycline was administered on the graft in the tetracycline group (tetra group, n = 50), a...

  20. Prospective, randomized comparison of simultaneous and sequential bilateral LASIK for the correction of myopia.

    OpenAIRE

    Waring, G O; Carr, J D; Stulting, R D; Thompson, K P

    1997-01-01

    PURPOSE: To study the safety and efficacy of simultaneous bilateral laser in-situ keratomileusis (LASIK) METHODS: Data were obtained from 254 consecutive patients that were randomized to simultaneous or sequential bilateral LASIK. RESULTS: 146 patients were enrolled in the simultaneous group and 108 patients were enrolled in the sequential group. Mean follow-up was 10 months (range 6-18). There was no significant difference in intraoperative complication rate (p = 0.34), loss of two or more l...

  1. Brinzolamide/timolol versus dorzolamide/timolol fixed combinations: A hospital-based, prospective, randomized study

    OpenAIRE

    Galose, Mary S; Heba M Elsaied; Macky, Tamer A; Fouad, Pakinam H

    2016-01-01

    Purpose: To compare the efficacy and tolerability of brinzolamide/timolol (BT) and dorzolamide/timolol (DT) fixed combinations on intraocular pressure (IOP) reduction. Methods: Patients with primary open angle glaucoma or normal tension glaucoma were randomized to receive either BT or DT. IOPs were measured at baseline, 2 weeks, and 1, 2, and 3 months. The primary outcome measures were the mean change in IOP from baseline at each visit. Secondary outcome measures included the tolerability of ...

  2. Prospective randomized controlled trial investigating the type of sutures used during hepatectomy

    Institute of Scientific and Technical Information of China (English)

    Norifumi Harimoto; Ken Shirabe; Tomoyuki Abe; Takafumi Yukaya; Eiji Tsujita; Tomonobu Gion; Kiyoshi Kajiyama; Takashi Nagaie

    2011-01-01

    AIM: To determine whether absorbable sutures or non-absorbable sutures are better in preventing surgical site infection (SSI), in this paper we discuss the results of a randomized clinical trial which examined the type of sutures used during hepatectomy. METHODS: All hepatic resections performed from January 2007 to November 2008 at the Department of Surgery at Iizuka Hospital in Japan were included in this study. There were 125 patients randomly assigned to an absorbable sutures (Vicryl) group or non-absorbable sutures (Silk) group. RESULTS: SSI was observed in 13.6% (17/125) patients participating in this study, 11.3% in the Vicryl group and 15.8% in the Silk group. Incisional SSI including superficial and deep SSI, was observed in 8% of the Vicryl group and 9.5% of the Silk group. Organ/ space SSI was observed in 3.2% of the Vicryl group and 6.0% of the Silk group. There were no significant differences, but among the patients with SSI, the period for recovery was significantly shorter for the Vicryl group compared to the Silk group. CONCLUSION: The incidence of SSI in patients receiving absorbable sutures and silk sutures is not significantly different in this randomized controlled study; however, the period for recovery in patients with SSI was significantly shorter for absorbable sutures.

  3. Spherical and aspherical photorefractive keratectomy and laser in-situ keratomileusis for moderate to high myopia: two prospective, randomized clinical trials. Summit technology PRK-LASIK study group.

    OpenAIRE

    Steinert, R F; Hersh, P S

    1998-01-01

    OBJECTIVE: Determine the outcomes of single-zone photorefractive keratectomy (SZPRK), aspherical photorefractive keratectomy (ASPRK), and laser in-situ keratomileusis (LASIK) for the correction of myopia between -6 and -12 diopters. DESIGN: Two simultaneous prospective, randomized, multi-center clinical trials. PARTICIPANTS: 286 first-treated eyes of 286 patients enrolled in one of two studies. In Study I, 134 eyes were randomized to SZPRK (58 eyes) or ASPRK (76 eyes). In Study II, 152 eyes w...

  4. Comparative study of bupivacaine alone and bupivacaine along with buprenorphine in axillary brachial plexus block: a prospective, randomized, single blind study

    OpenAIRE

    Kinjal S. Sanghvi; Vibhuti A. Shah; Kirti D. Patel

    2013-01-01

    Background: Different additives have been used to prolong brachial plexus block. We performed a prospective, randomized single-blind study to compare Bupivacaine alone and Bupivacaine along with Buprenorphine for onset, quality, and duration of block as well as post-operative analgesia and any complication in axillary brachial- plexus block. Methods: Randomized controlled study was carried out among 60 patients of either sex, aged 20-60 years. ASA grade I or II undergoing elective hand, forea...

  5. The effect of different doses of esmolol on hemodynamic, bispectral index and movement response during orotracheal intubation: prospective, randomized, double-blind study

    OpenAIRE

    Mensure Yılmaz Çakırgöz; Aydın Taşdöğen; Çimen Olguner; Hülya Korkmaz; Ertuğrul Öğün; Burak Küçükebe; Esra Duran

    2014-01-01

    Objective: A prospective, randomized and double-blind study was planned to identify the optimum dose of esmolol infusion to suppress the increase in bispectral index values and the movement and hemodynamic responses to tracheal intubation. Materials and methods: One hundred and twenty patients were randomly allocated to one of three groups in a double-blind fashion. 2.5 mg kg-1 propofol was administered for anesthesia induction. After loss of consciousness, and before administration of 0.6 ...

  6. Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

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    Nafisi Shahram

    2006-12-01

    Full Text Available Abstract Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic. Our study was conducted to answer the question: does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population? Method 395 healthy, nulliparous women, at term, presented in spontaneous labor with a singleton vertex presentation. These patients were randomized to receive analgesia either, epidural with bolus doses of 1% lidocaine or intravenous, with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters. The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded, in each patient. The total number of vacuum-assisted and cesarean deliveries were also measured. Results 197 women were randomized to the epidural group. 198 women were randomized to the single-dose intravenous meperidine group. There was no statistical difference in rates of vacuum-assisted delivery rate. Cesarean deliveries, as a consequence of fetal bradycardia or dystocia, did not differ significantly between the groups. Differences in the duration of the active-first and the second stages of labor were not statistically significant. The number of newborns with 1-min and 5-min Apgar scores less than 7, did not differ significantly between both analgesia groups. Conclusion Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate.

  7. The first French randomized prospective study of the economic and medical benefit of carbon ion radiotherapy

    International Nuclear Information System (INIS)

    Carbon ion therapy is an innovative radiotherapy modality for non-operable radio-resistant or resected cancers. Its efficiency is due to improved ballistic accuracy and biological efficiency. The authors present the first phase III study of carbon ion therapy in France. This technique concerns some sarcomas and adenoid cystic carcinomas of head and neck. The authors indicate the possible treatment procedures (doses, sessions) for the different types of cancers, and how the study is to be performed (number of patients, randomization, and multicentre approach). Short communication

  8. Optimal Shock Wave Rate for Shock Wave Lithotripsy in Urolithiasis Treatment: A Prospective Randomized Study

    OpenAIRE

    Moon, Keun Bai; Lim, Go San; Hwang, Jae Seung; Lim, Chae Hong; Lee, Jae Won; Son, Jeong Hwan; Jang, Seok Heun

    2012-01-01

    Purpose We aimed to compare the effects of a fast shock wave rate (120 shocks per minute) and a slow shock wave rate (60 shocks per minute) on the shock wave lithotripsy (SWL) success rate, patient's pain tolerance, and complications. Materials and Methods A total of 165 patients with radiopaque renal pelvis or upper ureter stones were included in the study. Patients were classified by use of a random numbers table. Group I (81 patients) received 60 shock waves per minute and group II (84 pat...

  9. Comparison of Postoperative Analgesic Efficacy of Penile Block, Caudal Block and Intravenous Paracetamol for Circumcision: A prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Ahmet Hakan Haliloglu

    2013-07-01

    Full Text Available Purpose To evaluate the postoperative analgesic efficacy of penile block, caudal block and intravenous paracetamol administration following circumcision. Materials and Methods In this prospective randomized study a total of 159 patients underwent circumcision under general anesthesia at urology clinic of Ufuk University Faculty of Medicine and Sorgun State Hospital between May 2012 and September 2012. The patients were randomized to three groups to receive penile block (Group 1, caudal block (Group 2 and intravenous paracetamol administration (group 3. Pain measurement of the patients was done via CHEOPS scoring system at 30,60,120 and 180 minutes postoperatively and compared. Statistical tests were performed with a conventional statistics program and statistical significance was set at a p value of < 0.05. Results The mean age of the patients was 5.7 years. Patients in group 1 had significantly lower pain score at 30 minutes compared to other two groups. At 60 minutes groups 1 and 2 had significantly lower score compared to group 3. At 120 and 180 minutes no difference between the groups was observed. No significant major complications were observed in all 3 groups. Conclusion Penile block and caudal block provide similar pain scores and painless postoperative periods after circumcision under general anesthesia. Intravenous paracetamol is insufficient at the early postoperative period. The three procedures were shown to be safe for analgesia following circumcision.

  10. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial

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    Henzen Christoph

    2007-07-01

    Full Text Available Abstract Background: Lower respiratory tract infections like acute bronchitis, exacerbated chronic obstructive pulmonary disease and community-acquired pneumonia are often unnecessarily treated with antibiotics, mainly because of physicians' difficulties to distinguish viral from bacterial cause and to estimate disease-severity. The goal of this trial is to compare medical outcomes, use of antibiotics and hospital resources in a strategy based on enforced evidence-based guidelines versus procalcitonin guided antibiotic therapy in patients with lower respiratory tract infections. Methods and design: We describe a prospective randomized controlled non-inferiority trial with an open intervention. We aim to randomize over a fixed recruitment period of 18 months a minimal number of 1002 patients from 6 hospitals in Switzerland. Patients must be >18 years of age with a lower respiratory tract infections Discussion: Use of and prolonged exposure to antibiotics in lower respiratory tract infections is high. The proposed trial investigates whether procalcitonin-guidance may safely reduce antibiotic consumption along with reductions in hospitalization costs and antibiotic resistance. It will additionally generate insights for improved prognostic assessment of patients with lower respiratory tract infections. Trial registration: ISRCTN95122877

  11. Radiation therapy for early glottic cancer (T1N0M0): II. Prospective randomized study concerning radiation field

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    Teshima, T.; Chatani, M.; Inoue, T. (Center for Adult Diseases, Osaka (Japan))

    1990-01-01

    A prospective randomized study to determine the effect of radiation field on the local control of early glottic cancer was performed. From May 1982 through December 1985, a total of 87 patients with early glottic cancer (T1N0M0) were treated at our department with an individualized wedge filter technique using a shell to improve the dose distribution and immobilization during radiotherapy with 4 MV X ray. Patients were randomly allocated to either treatment group A (radiation field size: 5 x 5 cm2) or B (6 x 6 cm2) using bilateral parallel opposed portals. Total radiation dose administered was 60 Gy in 30 fractions over a 6-week period. The 3-year recurrence-free survival rates were 93% in group A and 96% in group B (no significant difference). Comparison with historical control showed that both arms achieved better results. These results were mainly due to the improved local control of whole-length lesions of single vocal cords. Acute mucosal reaction (p less than 0.05) and persistent arytenoid edema lasting more than 6 months (p less than 0.02) were more frequently observed in group B than in group A. It is concluded that the critical factor in getting optimal results in the treatment of early glottic cancer is careful attention to the technique of treatment.

  12. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial.

    Science.gov (United States)

    Lee, Dong Gyu; Ahn, Sang-Ho; Lee, Jungwon

    2016-08-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  13. Azithromycin therapy of papillomatosis in dogs: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

    Science.gov (United States)

    Yağci, Buğrahan Bekir; Ural, Kerem; Ocal, Naci; Haydardedeoğlu, Ali Evren

    2008-08-01

    Azithromycin, an azalide subclass macrolide antibiotic, is an effective, well-tolerated and safe therapeutic option for treatment of papillomatosis in humans. This study reports the clinical and histopathological results from a prospective, randomized, double-blinded, placebo-controlled trial of 17 dogs of various breeds with diagnosis of oral (n = 12) and cutaneous papillomatosis (n = 5) treated with azithromycin. Papillomas appeared as whitish, verrucous, hyperkeratotic papules 1-2.7 mm in size. The cases were randomly assigned to azithromycin (n = 10) and placebo treatment groups (n = 7). Both owners and investigators were blinded to the allocation to the groups. Azithromycin (10 mg/kg) was administered per os every 24 h for 10 days. Clinical evaluations were done by the same investigator throughout the trial. Azithromycin treatment significantly decreased clinical scores (P azithromycin treatment group, skin lesions disappeared in 10-15 days. One case in the placebo had spontaneous regression of its papillomas by day 41, but lesions were still evident at day 50 in the remaining six cases. There was no recurrence of papillomatosis in the azithromycin treated dogs (follow up 8 months). No adverse effects were seen in either group. In conclusion, azithromycin appears to be a safe and effective treatment for canine papillomatosis. PMID:18494759

  14. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

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    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  15. Comparison of 7 and 8 French guiding catheters for elective PTCA: results of a prospective randomized trial.

    Science.gov (United States)

    Talley, J D; Wilkins, C; Ciccone, J; Hattel, L J

    1994-11-01

    A prospective randomized trial was performed to detect technical and clinical differences of 7F compared to 8F guiding catheters (GC) used in elective coronary angioplasty (PTCA). One hundred and fifteen patients undergoing elective PTCA with standard balloon dilatation catheters were randomized to 7F (55 pts) or 8F (58 pts) guiding catheters. The endpoints were primarily coronary artery and peripheral vascular complications; and secondarily, technical details and quantitative and qualitative angiographic quality. There was no difference between 7F or 8F GC for development of coronary or peripheral vascular complications. With 7F GC there was less blood loss (Hct, 3.5 +/- 3.4% vs. 6.5 +/- 9.6%, P = .033), and less contrast medium (160 +/- 88 mL vs. 200 +/- 119 mL, P = .049) used. Angiographic quality was similar, although visualization of lesions in the left anterior descending coronary artery in the left anterior oblique projection was improved with the 8F GC. There is no advantage of 7F GC for the prevention of coronary or peripheral vascular complications, although there was less blood loss and contrast medium used with the 7F systems. PMID:7874712

  16. Efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy: A prospective,randomized study

    Institute of Scientific and Technical Information of China (English)

    Thawatchai Akaraviputh; Charay Leelouhapong; Varut Lohsiriwat; Somkiat Aroonpruksakul

    2009-01-01

    AIM: To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy.METHODS: A prospective, double-blind, randomized,placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok,from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded.RESULTS: There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However,there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P = 0.053).

  17. Combination therapy with methotrexate and 5-fluorouracil: a prospective randomized clinical trial of order of administration.

    Science.gov (United States)

    Coates, A S; Tattersall, M H; Swanson, C; Hedley, D; Fox, R M; Raghavan, D

    1984-07-01

    Because of biochemical and tissue culture evidence casting doubt on the physiologic relevance of reported synergy afforded by sequential administration of methotrexate (MTX) followed by 5-fluorouracil (5-FU), a randomized controlled clinical trial was conducted in 108 patients with advanced cancer, including 70 with squamous cell carcinoma (SCC) of the head and neck, nine with SCC of other primary sites, 24 with colorectal, and five with gastric adenocarcinomas. Patients were randomized to receive weekly therapy consisting of MTX followed one hour later by 5-FU, or 5-FU followed one hour later by MTX. There was a trend to higher tumor response rates in patients treated with MTX before 5-FU (45% v 33% overall; 65% v 39% in patients with previously untreated head and neck cancer), but these differences were not significant, either by chi-square test or by multivariate stepwise logistic regression. The trend in survival favoring the reverse sequence of 5-FU before MTX was not significant in univariate analyses. Stepwise multivariate Cox model analysis showed that Eastern Cooperative Oncology Group performance status at study entry was the major prognostic factor for survival (P less than 0.001), but among the 70 patients with head and neck cancer, the sequence of drug administration was the only other significant prognostic factor for survival, and favored the sequence of 5-FU followed by MTX (P less than 0.025). PMID:6376719

  18. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Institute of Scientific and Technical Information of China (English)

    Yu Zhang; Hao-Ping Zhu; Jian-Xia Fan; Hong Yu; Li-Zhou Sun; Lian Chen; Qing Chang

    2015-01-01

    Background:In China,no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now.This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women.Methods:This was a double-blinded,prospective randomized controlled study including nulliparous women from 6 university hospitals across China.Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2.Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction.Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h.Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes.Results:A total of 173 women for misoprostol group and 49 women for placebo were analyzed.The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs.22.5%,relative risk [RR]:2.9,95% confidence interval [CI]:1.4-6.0).The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs.18.4%,RR:2.6,95% CI:1.2-5.7);and the induction-onset of labor interval was significantly shorter in the misoprostol group (P =0.0003).However,there were no significant differences in the median process time of vaginal labor (6.4 vs.6.8 h;P =0.695),incidence (39.3% vs.49.0%,RR:0.8,95% CI:0.4-1.5) and indications (P =0.683) of cesarean section deliveries,and frequencies of maternal,fetal/neonatal adverse events between the groups.Conclusion:Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.

  19. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Science.gov (United States)

    Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4–6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2–5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4–1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening. PMID:26481739

  20. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Yu Zhang

    2015-01-01

    Full Text Available Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4-6.0. The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2-5.7; and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003. However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695, incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4-1.5 and indications (P = 0.683 of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.

  1. Effects of gastric irrigation on bacterial counts before endoscopic submucosal dissection: a randomized case control prospective study.

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    Hirohito Mori

    Full Text Available OBJECTIVE: The antiseptic effect of gastric irrigation before endoscopic submucosal dissection (ESD has not yet been reported. The aim of the randomized prospective study is to evaluate the antiseptic effects of gastric irrigation of saline solution before ESD by evaluating bacterial count. METHODS: This prospective randomized controlled trial included 50 patients diagnosed with early gastric cancer who were randomly divided into 2 groups (25 patients in each group by using the opaque envelope method: the clean group (irrigation with 2 L saline solution before ESD and the regular group (no irrigation. The gastric juice was collected and cultured before ESD. The entire stomach was irrigated using a water jet attached to an endoscope. After ESD with resection and removal of the tumor specimen, a postoperative culture of the gastric juice was obtained using the same method as the preoperative culture. RESULTS: The mean log bacterial count of the post-gastric irrigation gastric juice was 5.08±0.75 in the regular group and 1.86±0.86 in the clean group. The difference in the bacterial counts was significant between the groups (P = 0.0004. The difference in the white blood cells (WBC count on POD 1 was significant (P = 0.044. WBC count on POD 2 did not significantly differ between the groups (P = 0.3. The difference in the body temperature (BT on POD 1 was significant (P = 0.017, On POD 2 the BT was not significant between the groups (P = 0.5. On POD 1, 88% of the patients in the regular group and 16% of the patients in the clean group had mild to moderate spontaneous pain (P = 0.0026. On POD 2 the proportion with mild to moderate spontaneous pain was 36% and 24% in the regular group and the clean group, respectively (P = 0.1. CONCLUSION: Pre-ESD gastric irrigation with saline solution is effective and feasible for suppressing infection during the ESD procedure with favorable clinical outcomes. TRIAL REGISTRATION

  2. Multidisciplinary management of stage III breast cancer: chemotherapy, surgery and radiotherapy

    International Nuclear Information System (INIS)

    A prospective study, in which women with clinically stage III breast cancer underwent multidisciplinary therapy by using primary (neoadjuvant) chemotherapy, followed randomly by loco-regionally therapy, either with surgery or radiotherapy; and postoperative systemic chemotherapy, in both groups of treatment, was conduced at the Peruvian Institute of Neoplasic Diseases. This is a randomized, prospective, descriptive, interventionist and analytical clinical study. Clinical response to primary chemotherapy was positive in 80,23% of cases, complete resolution was observed in 18,60% of cases, partial resolution in 61,63% of cases and there was absolutely no response in 19,77% of cases. No residual neoplasm, pathologically proven, was observed in 8,33% of surgical cases. We demonstrated that high-dose primary chemotherapy, using only 2 drugs (cyclophosphamide and 5-fluorouracil), used here because of its lower price, brought similar results compared to anthracycline-containing regimens. Recurrence rates were similar and showed no significative differences in both groups of treatment. Both, the disease-free survival (DFS) and overall survival (OS), were similar in both groups of treatment. We also demonstrated that in patients who underwent surgery, the lower the number of axillary lymph node metastases, the higher the overall survival (OS) time. Patients with clinically stage III (A or B) breast cancer, showed similar clinical responses to neoadjuvant chemotherapy, they also showed similar recurrence rates, DFS and OS, when treated with radical mastectomy or radiotherapy. (authors)

  3. Altered cerebral blood flow one month after systemic chemotherapy for breast cancer: a prospective study using pulsed arterial spin labeling MRI perfusion.

    Directory of Open Access Journals (Sweden)

    Kelly N H Nudelman

    Full Text Available Cerebral structural and functional alterations have been reported after chemotherapy for non-CNS cancers, yet the causative mechanism behind these changes remains unclear. This study employed a novel, non-invasive, MRI-based neuroimaging measure to provide the first direct longitudinal measurement of resting cerebral perfusion in breast cancer patients, which was tested for association with changes in cognitive function and gray matter density. Perfusion was measured using pulsed arterial spin labeling MRI in women with breast cancer treated with (N = 27 or without (N = 26 chemotherapy and matched healthy controls (N = 26 after surgery before other treatments (baseline, and one month after chemotherapy completion or yoked intervals. Voxel-based analysis was employed to assess perfusion in gray matter; changes were examined in relation to overall neuropsychological test performance and frontal gray matter density changes measured by structural MRI. Baseline perfusion was not significantly different across groups. Unlike control groups, chemotherapy-treated patients demonstrated significantly increased perfusion post-treatment relative to baseline, which was statistically significant relative to controls in the right precentral gyrus. This perfusion increase was negatively correlated with baseline overall neuropsychological performance, but was not associated with frontal gray matter density reduction. However, decreased frontal gray matter density was associated with decreased perfusion in bilateral frontal and parietal lobes in the chemotherapy-treated group. These findings indicate that chemotherapy is associated with alterations in cerebral perfusion which are both related to and independent of gray matter changes. This pattern of results suggests the involvement of multiple mechanisms of chemotherapy-induced cognitive dysfunction. Additionally, lower baseline cognitive function may be a risk factor for treatment

  4. Sleep quality in patients with xerostomia: a prospective and randomized case-control study.

    Science.gov (United States)

    Lopez-Jornet, Pia; Lucero Berdugo, Maira; Fernandez-Pujante, Alba; C, Castillo Felipe; Lavella C, Zamora; A, Pons-Fuster; J, Silvestre Rangil; Silvestre, Francisco Javier

    2016-01-01

    Objectives To investigate sleep quality, anxiety/depression and quality-of-life in patients with xerostomia. Materials and methods This prospective, observational, cross-sectional study was conducted among a group of xerostomia patients (n = 30) compared with 30 matched control subjects. The following evaluation scales were used to assess the psychological profile of each patient: the Hospital Anxiety and Depression Scale, the Oral Health Impact Profile-14 (OHIP-14), the Xerostomia Inventory, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Results The PSQI obtained 5.3 3 ± 1.78 for patients with xerostomia compared with 4.26 ± 1.01 for control subjects (p = 0.006); ESS obtained 5.7 ± 2.1 for test patients vs 4.4 0 ± 1 for control subjects (p = 0.010). Statistical regression analysis showed that xerostomia was significantly associated with depression (p = 0.027). Conclusions Patients with xerostomia exhibited significant decreases in sleep quality compared with control subjects. PMID:26473793

  5. Significant negative impact of adjuvant chemotherapy on Health-Related Ouality of Life (HR-OoL) in women with breast cancer treated by conserving surgery and postoperative 3-D radiotherapy. A prospective measurement

    Energy Technology Data Exchange (ETDEWEB)

    Galalae, R.M.; Michel, J.; Kimmig, B. [Clinic for Radiation Therapy (Radiooncology), Univ. Hospital Schleswig-Holstein, Campus Kiel (Germany); Siebmann, J.U.; Kuechler, T.; Eilf, K. [Dept. of General and Thoracic Surgery/Reference Center on Quality of Life in Oncology, Univ. Hospital Schleswig-Holstein, Campus Kiel (Germany)

    2005-10-01

    Purpose: to prospectively assess health-related quality of life (HR-QoL) in women after conserving surgery for breast cancer during/after postoperative 3-D radiotherapy. Patients and methods: 109 consecutively treated patients were analyzed. HR-QoL was assessed at initiation (t1), end (t2), and 6 weeks after radiotherapy (t3) using the EORTC modules QLQ-C30/BR23. Patients were divided into three therapy groups. Group I comprised 41 patients (radiotherapy and adjuvant chemotherapy), group II 45 patients (radiotherapy and adjuvant hormonal therapy), and group III 23 patients (radiotherapy alone). Reliability was tested. Scale means were calculated. Univariate (ANOVA) and multivariate (MANCOVA) analyses were performed. Results: reliability testing revealed mean Cronbach's {alpha} > 0.70 at all measurement points. ANOVA/MANCOVA statistics revealed significantly better HR-QoL for patients in group II versus I. Patients receiving radiotherapy alone (group III) showed the best results in HR-QoL. However, scale mean differences between groups II and III were not significant. Conclusion: HR-QoL measurement using EORTC instruments during/after radiotherapy is reliable. Adjuvant chemotherapy significantly lowered HR-QoL versus hormones or radiotherapy alone. Chemotherapy patients did not recover longitudinally (from t1 to t3). (orig.)

  6. Significant negative impact of adjuvant chemotherapy on Health-Related Quality of Life (HR-OoL) in women with breast cancer treated by conserving surgery and postoperative 3-D radiotherapy. A prospective measurement

    International Nuclear Information System (INIS)

    Purpose: to prospectively assess health-related quality of life (HR-QoL) in women after conserving surgery for breast cancer during/after postoperative 3-D radiotherapy. Patients and methods: 109 consecutively treated patients were analyzed. HR-QoL was assessed at initiation (t1), end (t2), and 6 weeks after radiotherapy (t3) using the EORTC modules QLQ-C30/BR23. Patients were divided into three therapy groups. Group I comprised 41 patients (radiotherapy and adjuvant chemotherapy), group II 45 patients (radiotherapy and adjuvant hormonal therapy), and group III 23 patients (radiotherapy alone). Reliability was tested. Scale means were calculated. Univariate (ANOVA) and multivariate (MANCOVA) analyses were performed. Results: reliability testing revealed mean Cronbach's α > 0.70 at all measurement points. ANOVA/MANCOVA statistics revealed significantly better HR-QoL for patients in group II versus I. Patients receiving radiotherapy alone (group III) showed the best results in HR-QoL. However, scale mean differences between groups II and III were not significant. Conclusion: HR-QoL measurement using EORTC instruments during/after radiotherapy is reliable. Adjuvant chemotherapy significantly lowered HR-QoL versus hormones or radiotherapy alone. Chemotherapy patients did not recover longitudinally (from t1 to t3). (orig.)

  7. A six-year prospective randomized study of a nano-hybrid and a conventional hybrid resin composite in Class II restorations

    DEFF Research Database (Denmark)

    van Dijken, Jan W V; Pallesen, Ulla

    2013-01-01

    The objective of this 6 year prospective randomized equivalence trial was to evaluate the long-term clinical performance of a new nano-hybrid resin composite (RC) in Class II restorations in an intraindividual comparison with its well-established conventional hybrid RC predecessor....

  8. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients : a prospective randomized multicentre study

    NARCIS (Netherlands)

    Scheeren, Thomas W. L.; Wiesenack, Christoph; Gerlach, Herwig; Marx, Gernot

    2013-01-01

    Perioperative hemodynamic optimisation improves postoperative outcome for patients undergoing high-risk surgery (HRS). In this prospective randomized multicentre study we studied the effects of an individualized, goal-directed fluid management based on continuous stroke volume variation (SVV) and st

  9. No important influence of limited steroid exposure on bone mass during the first year after renal transplantation: a prospective, randomized, multicenter study.

    NARCIS (Netherlands)

    Meulen, C.G. ter; Riemsdijk, I.C. van; Hene, R.J.; Christiaans, M.H.; Borm, G.F.; Corstens, F.H.M.; Gelder, T. van; Hilbrands, L.B.; Weimar, W.; Hoitsma, A.J.

    2004-01-01

    BACKGROUND: Steroid-related bone loss is a recognized complication after renal transplantation. In a prospective, randomized, multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal t

  10. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig; Holm, Gitte; Jacobsen, Tine W; Gebuhr, Peter Henrik

    2003-01-01

    INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed...

  11. The prophylactic effect of ceftazidime on early bacterial infection after autologous peripheral blood stem cell transplantation: a prospective randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    段明辉

    2013-01-01

    Objective To evaluate the efficacy and safety of prophylactic ceftazidime on early bacterial infection in APBSCT recipients during neutropenia.Methods APBSCT recipients were prospectively randomly assigned to intravenous ceftazidime treatment group and control group (no prophylaxis of antibiotics) .The treatment started from the first day until resolution of neutropenia or the

  12. High-vs low-dose cytarabine combined with interferon alfa in patients with first chronic phase chronic myeloid leukemia. A prospective randomized phase III study

    NARCIS (Netherlands)

    Deenik, W.; van der Holt, B.; Verhoef, G. E. G.; Schattenberg, A. V. M. B.; Verdonck, L. F.; Daenen, S. M. G. J.; Zachee, P.; Westveer, P. H. M.; Smit, W. M.; Wittebol, S.; Schouten, H. C.; Lowenberg, B.; Ossenkoppele, G. J.; Cornelissen, J. J.

    2007-01-01

    A prospective randomized phase III study was performed to evaluate whether intensified cytarabine would induce a higher response rate and longer event-free interval as compared to low-dose cytarabine in chronic myeloid leukemia (CML). One hundred and eighteen patients with CML in early chronic phase

  13. High-vs low-dose cytarabine combined with interferon alfa in patients with first chronic phase chronic myeloid leukemia : A prospective randomized phase III study

    NARCIS (Netherlands)

    Deenik, W.; Holt, B. van der; Verhoef, G.E.; Schattenberg, A.V.M.B.; Verdonck, L.F.; Daenen, S.M.G.J.; Zachee, P.; Westveer, P.H.; Smit, W.M.; Wittebol, S.; Schouten, H.C.; Lowenberg, B.; Ossenkoppele, G.J.; Cornelissen, J.J.L.M.

    2007-01-01

    A prospective randomized phase III study was performed to evaluate whether intensified cytarabine would induce a higher response rate and longer event-free interval as compared to low-dose cytarabine in chronic myeloid leukemia (CML). One hundred and eighteen patients with CML in early chronic phase

  14. Onyalai--therapeutic effects of vincristine sulphate. A prospective randomized trial.

    Science.gov (United States)

    Hesseling, P B; Girdle-Brown, B; Smit, J

    1986-08-16

    Twenty out of 40 patients with onyalai admitted to Rundu State Hospital, Kavango, SWA/Namibia, were randomized to receive a vincristine sulphate bolus of 1.5 mg/m2 or an equivalent volume of normal saline intravenously on days 8 and 15 when haemorrhage or a platelet count of less than 50 X 10(9)/l persisted for more than 1 week after admission. All patients were observed in hospital for at least 21 days. Five out of 10 patients who received vincristine achieved a platelet count in excess of 100 X 10(9)/l on day 21 and only 2 out of 10 patients who received placebo achieved a similar rise in the platelet count. Two patients, neither of whom was treated with vincristine, died of cerebral haemorrhage. PMID:3738655

  15. Limited Chemotherapy and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective Trial

    International Nuclear Information System (INIS)

    Purpose: To establish benchmark outcomes for combined modality treatment to be used in future prospective studies of osteolymphoma (primary bone lymphoma). Methods and Materials: In 1999, the Trans-Tasman Radiation Oncology Group (TROG) invited the Australasian Leukemia and Lymphoma Group (ALLG) to collaborate on a prospective study of limited chemotherapy and radiotherapy for osteolymphoma. The treatment was designed to maintain efficacy but limit the risk of subsequent pathological fractures. Patient assessment included both functional imaging and isotope bone scanning. Treatment included three cycles of CHOP chemotherapy and radiation to a dose of 45 Gy in 25 fractions using a shrinking field technique. Results: The trial closed because of slow accrual after 33 patients had been entered. Accrual was noted to slow down after Rituximab became readily available in Australia. After a median follow-up of 4.3 years, the five-year overall survival and local control rates are estimated at 90% and 72% respectively. Three patients had fractures at presentation that persisted after treatment, one with recurrent lymphoma. Conclusions: Relatively high rates of survival were achieved but the number of local failures suggests that the dose of radiotherapy should remain higher than it is for other types of lymphoma. Disability after treatment due to pathological fracture was not seen.

  16. A prospective randomized trial of content expertise versus process expertise in small group teaching

    Directory of Open Access Journals (Sweden)

    Wright Bruce

    2010-10-01

    Full Text Available Abstract Background Effective teaching requires an understanding of both what (content knowledge and how (process knowledge to teach. While previous studies involving medical students have compared preceptors with greater or lesser content knowledge, it is unclear whether process expertise can compensate for deficient content expertise. Therefore, the objective of our study was to compare the effect of preceptors with process expertise to those with content expertise on medical students' learning outcomes in a structured small group environment. Methods One hundred and fifty-one first year medical students were randomized to 11 groups for the small group component of the Cardiovascular-Respiratory course at the University of Calgary. Each group was then block randomized to one of three streams for the entire course: tutoring exclusively by physicians with content expertise (n = 5, tutoring exclusively by physicians with process expertise (n = 3, and tutoring by content experts for 11 sessions and process experts for 10 sessions (n = 3. After each of the 21 small group sessions, students evaluated their preceptors' teaching with a standardized instrument. Students' knowledge acquisition was assessed by an end-of-course multiple choice (EOC-MCQ examination. Results Students rated the process experts significantly higher on each of the instrument's 15 items, including the overall rating. Students' mean score (±SD on the EOC-MCQ exam was 76.1% (8.1 for groups taught by content experts, 78.2% (7.8 for the combination group and 79.5% (9.2 for process expert groups (p = 0.11. By linear regression student performance was higher if they had been taught by process experts (regression coefficient 2.7 [0.1, 5.4], p Conclusions When preceptors are physicians, content expertise is not a prerequisite to teach first year medical students within a structured small group environment; preceptors with process expertise result in at least equivalent, if not

  17. The efficiency and safety of trastuzumab and lapatinib added to neoadjuvant chemotherapy in Her2-positive breast cancer patients: a randomized meta-analysis

    Directory of Open Access Journals (Sweden)

    Chen ZL

    2016-05-01

    Full Text Available Zhe-Ling Chen, Yan-Wei Shen, Shu-Ting Li, Chun-Li Li, Ling-Xiao Zhang, Jiao Yang, Meng Lv, Ya-Yun Lin, Xin Wang, Jin Yang Department of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, People’s Republic of China Background: The addition of human epidermal growth factor receptor 2 (Her2 therapies to neoadjuvant chemotherapy (NAC during treatment of Her2-positive breast cancer has been proposed as an effective way to improve the prognosis. However, the treatment outcomes of adding trastuzumab, lapatinib, or both to NAC were not unequivocal in randomized clinical trials. Based on these data, a meta-analysis was performed. Objective: The main objective was to evaluate the efficiency and safety of trastuzumab and lapatinib added to NAC for treatment of Her2-positive breast cancer. Methods: ClinicalTrials.gov and PubMed were searched for randomized clinical trials that compared trastuzumab, lapatinib, or both, added to NAC. The main endpoint was a pathologically complete response (pCR rate, in breast only or in breast and lymph nodes. The drug safety and the influence of hormone-receptor status, comparing the clinical response and the rate of breast conservation, were evaluated. Results: A total of eight publications were included in the primary analysis, designed as two or three subgroups. The cumulative cases were 2,349 and the analyses of all the clinical trials showed that the pCR rate was significantly higher in the group receiving trastuzumab than that in the group with lapatinib, either in breast only (P=0.001 or in breast and lymph nodes (P=0.0001. Similar results could be seen in comparisons of the combination versus trastuzumab group. Further studies of subgroups divided into hormone receptor-positive or-negative patients showed that the addition of trastuzumab or dual Her2-targeted therapy significantly improved the pCR rate in patients who were hormone-insensitive. Regarding the toxic

  18. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

    Science.gov (United States)

    Ala, Shahram; Saeedi, Majid; Janbabai, Ghasem; Ganji, Reza; Azhdari, Elham; Shiva, Afshin

    2016-04-01

    Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis. PMID:27007594

  19. Quinine improves results of intensive chemotherapy (IC) in myelodysplastic syndromes (MDS) expressing P-glycoprotein (PGP). Updated results of a randomized study. Groupe Français des Myélodysplasies (GFM) and Groupe GOELAMS.

    Science.gov (United States)

    Wattel, E; Solary, E; Hecquet, B; Caillot, D; Ifrah, N; Brion, A; Milpied, N; Janvier, M; Guerci, A; Rochant, H; Cordonnier, C; Dreyfus, F; Veil, A; Hoang-Ngoc, L; Stoppa, A M; Gratecos, N; Sadoun, A; Tilly, H; Brice, P; Lioure, B; Desablens, B; Pignon, B; Abgrall, J P; Leporrier, M; Fenaux, P

    1999-01-01

    We designed a randomized trial of IC with or without quinine, an agent capable of reverting the multidrug resistance (mdr) phenotype, in patients aged < or = 65 years with high risk MDS. Patients were randomized to receive Mitoxantrone 12 mg/m2/d d2-5 + AraC 1 g/m2/12 h d1-5, with (Q+) or without (Q-) quinine (30 mg/kg/day). 131 patients were included. PGP expression analysis was successfully made in 91 patients and 42 patients (46%) had positive PGP expression. In PGP positive cases, 13 of the 25 (52%) patients who received quinine achieved CR, as compared to 3 of the 17 (18%) patients treated with chemotherapy alone (p = 0.02). In PGP negative cases, the CR rate was 35% and 49%, respectively in patients who received quinine or chemotherapy alone (difference not significant). In the 42 PGP positive patients, median Kaplan-Meier (KM) survival was 13 months in patients allocated to the quinine group, and 8 months in patients treated with chemotherapy alone (p = 0.01). In PGP negative patients, median KM survival was 14 months in patients allocated to the quinine group, and 14 months in patients treated with chemotherapy alone. Side effects of quinine mainly included vertigo and tinnitus that generally disappeared with dose reduction. Mucositis was significantly more frequently observed in the quinine group. No life threatening cardiac toxicity was observed. In conclusion, results of this randomized study show that quinine increases the CR rate and survival in PGP positive MDS cases treated with IC. The fact that quinine had no effect on the response rate and survival of PGP negative MDS suggests a specific effect on PGP mediated drug resistance rather than, for instance, a simple effect on the metabolism of Mitoxantrone and/or AraC. PMID:10500778

  20. Induction chemotherapy with paclitaxel and cisplatin to concurrent radiotherapy and weekly paclitaxel in the treatment of loco-regionally advanced, stage IV (M0), head and neck squamous cell carcinoma. Mature results of a prospective study

    International Nuclear Information System (INIS)

    to evaluate activity and toxicity of a sequential treatment in advanced, non metastatic, mostly unresectable, head and neck squamous cell carcinoma. Patients with loco-regionally advanced or unresectable, head and neck cancer, were prospectively treated with 3 courses of induction chemotherapy followed by concurrent chemoradiation. Induction chemotherapy consisted of paclitaxel 175 mg/m2 day 1 and cisplatin 75 mg/m2 day 2, given every 3 weeks, to a total of three courses. Curative radiotherapy started 4 weeks after the last cycle of chemotherapy with the goal of delivering a total dose ≥ 66 Gy. During RT weekly paclitaxel (40 mg/m2) was administered. The trial accrued 43 patients from January 1999 to December 2002. All patients received 3 courses of induction chemotherapy and the planned dose of radiotherapy. Thirty-eight patients were able to tolerate weekly paclitaxel during irradiation at least for 4 courses. After induction therapy there were 32 overall responses, 74.4% (23 partial and 9 complete); at completion of concomitant treatment overall responses were 42, 97.7% (20 partial and 22 complete). Median time to treatment failure was 20 months and the disease progression rate at 3 and 5 years was 33% and 23%, respectively. The median overall survival time was 24 months and 3 and 5 years overall survival rates were 37% and 26%, respectively. The major toxicity was mucositis. This combined treatment was found to be feasible and active in advanced or unresectable, head and neck squamous cell carcinoma patients. Long-term results observed in this trial encourage to consider this approach in further investigation using newer radiation delivering technique and new molecularly agents

  1. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study

    Directory of Open Access Journals (Sweden)

    Martínez Luis

    2010-02-01

    Full Text Available Abstract Background A frequent manifestation of advanced NSCLC is malnutrition, even though there are many studies which relate it with a poor survival, its relation with toxicity has not yet been consistently reported. The aim of this study was to associate malnutrition and albumin serum levels with the occurrence of chemotherapy-induced toxicity in cisplatin plus paclitaxel chemotherapy-treated NSCLC. Methods We prospectively evaluated 100 stage IV NSCLC patients treated with paclitaxel (175 mg/m2 and cisplatin (80 mg/m2. Malnutrition was assessed using SGA prior treatment. Neutrophil Lymphocyte Ratio (NLR and the Platelet Lymphocyte Ratio (PLR were used to determine the presence of systemic inflammatory response (SIR and were related to the development of toxicity. Toxicity was graded according to NCI CTCAE version 3.0 after two chemotherapy cycles. Results Median age was 58 ± 10 years, 51% of patients were malnourished, 50% had albumin ≤3.0 mg/mL. NLR ≥ 5 was associated with basal hypoalbuminemia (mean ranks, 55.7 vs. 39 p = 0.006, ECOG = 2 (47.2 vs. 55.4 p = 0.026 and PLR ≥ 150 were significantly related with a basal body mass index ≤20 (56.6 vs. 43.5; p = 0.02 and hypoalbuminemia (58.9 vs. 41.3; p = 0.02. Main toxicities observed after 2 cycles of chemotherapy were alopecia (84%, nausea (49%, neuropathy (46%, anemia (33%, lymphopenia (31%, and leukopenia (30%. Patients malnourished and with hypoalbuminemia developed more chemotherapy-induced toxicity overall when compared with those without malnutrition (31 vs 22; p = 0.02 and normal albumin (mean ranks, 62 vs 43; p = 0.002, respectively. Hypoalbuminemia was associated with anemia (56 vs 47; p = 0.05, fatigue (58 vs 46; p = 0.01, and appetite loss (57.1 vs 46.7; p = 0.004 compared with normal albumin. PLR ≥ 150 was related with the development of toxicity grade III/IV (59.27 vs. 47.03 p = 0.008 and anemia (37.9 vs 53.8 p = 0.004. Conclusion SIR parameters were associated with

  2. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study

    International Nuclear Information System (INIS)

    A frequent manifestation of advanced NSCLC is malnutrition, even though there are many studies which relate it with a poor survival, its relation with toxicity has not yet been consistently reported. The aim of this study was to associate malnutrition and albumin serum levels with the occurrence of chemotherapy-induced toxicity in cisplatin plus paclitaxel chemotherapy-treated NSCLC. We prospectively evaluated 100 stage IV NSCLC patients treated with paclitaxel (175 mg/m2) and cisplatin (80 mg/m2). Malnutrition was assessed using SGA prior treatment. Neutrophil Lymphocyte Ratio (NLR) and the Platelet Lymphocyte Ratio (PLR) were used to determine the presence of systemic inflammatory response (SIR) and were related to the development of toxicity. Toxicity was graded according to NCI CTCAE version 3.0 after two chemotherapy cycles. Median age was 58 ± 10 years, 51% of patients were malnourished, 50% had albumin ≤3.0 mg/mL. NLR ≥ 5 was associated with basal hypoalbuminemia (mean ranks, 55.7 vs. 39 p = 0.006), ECOG = 2 (47.2 vs. 55.4 p = 0.026) and PLR ≥ 150 were significantly related with a basal body mass index ≤20 (56.6 vs. 43.5; p = 0.02) and hypoalbuminemia (58.9 vs. 41.3; p = 0.02). Main toxicities observed after 2 cycles of chemotherapy were alopecia (84%), nausea (49%), neuropathy (46%), anemia (33%), lymphopenia (31%), and leukopenia (30%). Patients malnourished and with hypoalbuminemia developed more chemotherapy-induced toxicity overall when compared with those without malnutrition (31 vs 22; p = 0.02) and normal albumin (mean ranks, 62 vs 43; p = 0.002), respectively. Hypoalbuminemia was associated with anemia (56 vs 47; p = 0.05), fatigue (58 vs 46; p = 0.01), and appetite loss (57.1 vs 46.7; p = 0.004) compared with normal albumin. PLR ≥ 150 was related with the development of toxicity grade III/IV (59.27 vs. 47.03 p = 0.008) and anemia (37.9 vs 53.8 p = 0.004). SIR parameters were associated with malnutrition, weight loss and hypoalbuminemia

  3. SPINAL ANAESTHESIA VERSUS GENERAL ANAESTHESIA FOR LAPAROSCOPIC CHOLECYSTECTOMY - A PROSPECTIVE RANDOMIZED CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Prasad

    2014-02-01

    Full Text Available INTRODUCTION: Combining minimal invasive surgical and lesser invasive anesthesia technique reduces morbidity and mortality. The aim of the study is to compare spinal anesthesia with the gold standard general anesthesia for elective laparoscopic cholecystectomy. MATERIALS & METHODS: 60 healthy patients were randomized under spinal anesthesia (n=30 & General Anesthesia (n=30 . Hyperbaric 3ml bupivacaine plus 25mcg fenta nyl was administered for spinal group and conventional general anesthesia for GA group. Intraoperative parameters and post - operative pain and recovery were noted. Under spinal group any intraoperative discomfort were taken care by reassurance , drugs or con verted to GA. Questionnaire forms were provided for patients and surgeons to comment about the operation. RESULTS: None of the patients had significant hemodynamic and respiratory disturbance except for transient hypotension and bradycardia. Operative time was comparable. 6patients under spinal anesthesia had right shoulder pain , 2 patients were converted to GA and 4 patients were managed by injection midazolam and infiltration of lignocaine over the diaphragm. There was significant post - operative pain reli ef in spinal group. All the patients were comfortable and surgeons satisfied. CONCLUSION: Spinal anesthesia is adequate and safe for laparoscopic cholecystectomy in otherwise healthy patients and offers better postoperative pain control than general anesth esia without limiting recovery , but require cooperative patient , skilled surgeon , a gentle surgical technique and an enthusiastic anesthesiologist

  4. Randomized prospective study evaluating addition of corticoid to viscosupplementation: three months of follow-up

    Directory of Open Access Journals (Sweden)

    Gustavo Constantino de Campos

    2013-08-01

    Full Text Available OBJECTIVE: To assess if the initial results of viscosupplementation are improved by the addition of corticosteroid. DESIGN: We evaluated 104 patients receiving usual care for knee osteoarthritis at the Universidade de São Paulo Medical Center. Patients were randomized to receive either a single intra-articular injection of 6 mL of Hylan GF-20 (Group 1 or a single intra-articular injection of 6 mL of Hylan GF-20 plus 1 mL (20 mg of Triamcinolone Hexacetonide (Group 2. VAS, WOMAC and Lequesne questionnaires were applied at weeks zero (prior the injection, and after one, four, and 12 weeks. RESULTS: The baseline measurements of the two groups with 52 patients each were not statistically different. At week one, WOMAC and VAS showed significantly better results for Group 2 compared to Group 1 (p < 0,05. At week four the scores did not show a statistically significant differences. The groups showed similar results at week 12. CONCLUSION: The addition of Triamcinolone Hexacetonide improves the short term symptom/functional scores of viscosupplementation.

  5. Prospective randomized clinical trial of non-small cell lung cancer for intraoperative radiotherapy

    International Nuclear Information System (INIS)

    Objective: To analyse the long-term effect of non-small cell lung cancer treated with either postoperative irradiation(group A) or intraoperative radiotherapy(IORT) followed by postoperative irradiation( group B). Methods: 154 patients with non-small cell lung carcinoma were randomized into two groups(groups A and B) with 77 patients in each. There were 134 squamous, 17 adenocarcinoma and 3 adeno-squamous carcinoma. Seventeen patients had stage I, 76 stage II and 61 stage III lesions. The dose of postoperative irradiation in both groups was DT40-60 Gy. In group B, the IORT dose was 15-25 Gy, delivered by 9-16 MeV electrons. Results: The local control rate was 49% and 62% in groups A and B, respectively (P0.05). Sixteen patients died of radiotherapy-induced complication: 2 in group A and 14 in group B. Conclusions: Intraoperative radiotherapy followed by postoperative irradiation can enhance the local control rate of non-small cell lung cancer but can not improve the long term survival, The high complication mortality rate of IORT (18%) in contrast to that (3%) of postoperative radiotherapy is worth noticing. (authors)

  6. H pylori eradication:A randomized prospective study of triple therapy with or without ecabet sodium

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    AIM:To investigate whether adding ecabet sodium to the standard triple therapy for Hpylori infection improve eradication rate.METHODS:Two hundred and fifty-seven H pyloriinfected patients were randomly assigned to standard triple therapy (group A, n=129) or triple therapy plus ecabet sodium(group B, n=128).Successful eradication was defined as a negative 13C-urea breath test 6-8 wk after completion of treatment.RESULTS:After completion of therapy,194/257 patients showed negative 13C-urea breath test results.According to intention-to-treat analysis,the infection was eradicated in 93/129(72.1%)patients in group A and 101/128 (78.9%) in group B (P=0.204).Per-protocol analysis showed successful eradication in 93/118(78.8%)patients from group A and 101/114 (88.6%) from group B (P = 0.044).There were no significant differences in the side effects experienced by the patients in the two treatment groups.CONCLUSION:Our results suggest that the addition of ecabet sodium improves the efficacy of the standard triple therapy for H pylori.

  7. Hypofractionated radiation therapy in the treatment of epidemic Kaposi sarcoma - A prospective randomized trial

    International Nuclear Information System (INIS)

    Purpose: To compare a conventional fractionation regimen with a hypofractionated regimen in the treatment of Epidemic Kaposi sarcoma with radiation therapy. Materials and methods: Sixty patients were randomized to receive a standard regimen of 24 Gy in 12 fractions (ARM A) or the study regimen of 20 Gy in five fractions (ARM B). Radiation technique was individualized. Treatment response, local control and toxicity were recorded. Results: Thirty five sites were treated in ARM A and 30 sites in ARM B. Treatment arms were similar for gender, ECOG performance score, treated site, antiretroviral therapy usage, T stage, I stage and S stage. The overall survival using the Kaplan Meier method was 37% at 1 year. Complete responses were recorded at 28 sites (13 Arm A, 15 Arm B), partial responses at 19 sites (8 Arm A, 11 Arm B) and stable disease at three sites (2 Arm A, 1 Arm B). The mean time to maximum objective response was 3 months (range: 1-14 months). Response rates and local control were equal in the two arms (p = 0.73 and 0.77, respectively, log rank test). Acute skin toxicity (p = 0.77) and late skin toxicity (p = 0.24) were equal in the two arms. Conclusion: The two treatment regimens produced equivalent results for treatment response, local recurrence-free survival and toxicity

  8. Results of radiotherapy and combined radiotherapy and chemotherapy of inoperable lung cancer (A joint randomized study in some CMEA member countries, project 9.1.3 of the 9.1 Lung Cancer Program)

    International Nuclear Information System (INIS)

    A comparative analysis is presented of immediate results after radiotherapy and combined treatment (radio- and chemotherapy) in 174 patients with highly differentiated inoperable lung cancer. The data were provided by the participants of joint investigation in some CMEA member countries (Hungary, USSR, Czechoslovakia) during the period of 1976 to 1980. In the randomized study, radiotherapy (a total dose of 60 Gy) was applied in 98 patients, radiotherapy with chemotherapy (methotrexate and 5-fluorouracil) was applied in 76 patients. The comparative analysis showed that the employment of complementary chemotherapy tends to improve the immediate therapeutic effects. In case of highly differentiated planocellular carcinoma a pronounced positive effect was seen in 48.6% of patients as compared to 31.2% of those treated with radiotherapy alone. Nevertheless, with respect to survival rate extension, these differences are not in favor of the combined method of treatment. After conservative treatment (radiotherapy and radiotherapy in combination with chemotherapy) of patients with differentiated types of inoperable lung cancer, a one-year survival rate was recorded in 55.7%, 17.27% of the patients survived for 2 years, and 8.55% for 3 years. In radiotherapy applied alone and in combination, a direct dependence of survival rate extension on therapeutical effects was detected. 49 patients (73.1%) out of 67 exhibiting pronounced immediate effects survived for more than 1 year and 8 patients out of 9 survived for 3 years. (author)

  9. Hyperfractionated versus conventional radiotherapy followed by chemotherapy in standard-risk medulloblastoma: Results from the randomized multicenter HIT-SIOP PNET 4 trial

    NARCIS (Netherlands)

    B. Lannering (Birgitta); P. Rutkowski (Piotr); F.F. Doz (François); B. Pizer (Barry); G. Gustafsson (Göran); A. Navajas (Aurora); M. Massimino (Maura); R.E. Reddingius (Roel); M. Benesch (Martin); C. Carrie (Christian); R. Taylor; L. Gandola (Lorenza); T. Bjor̈k-Eriksson (Thomas); S. Giralt; F. Oldenburger (Foppe); T. Pietsch (Torsten); D. Figarella-Branger (Dominique); K. Robson (Kathryn); G. Forni (Gianluca); S.C. Clifford (Steven); M. Warmuth-Metz (Monica); D.D. Von Hoff; A. Faldum (Andreas); V. Mosseri (Véronique); B. Kortmann

    2012-01-01

    textabstractPurpose: To compare event-free survival (EFS), overall survival (OS), pattern of relapse, and hearing loss in children with standard-risk medulloblastoma treated by postoperative hyperfractionated or conventionally fractionated radiotherapy followed by maintenance chemotherapy. Patients

  10. A randomized phase III trial on maintenance treatment with bevacizumab alone or in combination with erlotinib after chemotherapy and bevacizumab in metastatic colorectal cancer

    DEFF Research Database (Denmark)

    Johnsson, Anders; Hagman, H; Frödin, J-E;

    2013-01-01

    The main objective was to study the effect on progression-free survival (PFS) of adding erlotinib to bevacizumab as maintenance treatment following chemotherapy and bevacizumab as first-line treatment of metastatic colorectal cancer (mCRC)....

  11. A phase 1–2, prospective, double blind, randomized study of the safety and efficacy of Sulfasalazine for the treatment of progressing malignant gliomas: study protocol of [ISRCTN45828668

    International Nuclear Information System (INIS)

    The prognosis of patients suffering from WHO grade 3 and 4 astrocytic glioma remains poor despite surgery, radiation therapy and the use of current chemotherapy regimen. Indeed, the median survival of glioblastoma multiforme (WHO grade 4) patients is at best 14.6 month with only 26.5 percents of the patients still alive after 2 years and the median survival of anaplastic astrocytomas (WHO grade 3) is 19.2 month. Recent evidence suggests that the transcription factor NF-kappaB is constitutively expressed in malignant gliomas and that its inhibition by drugs like Sulfasalazine may block the growth of astrocytic tumors in vitro and in experimental models of malignant gliomas. ULg-GBM-04/1 is a prospective, randomized, double blind single-center phase 1–2 study. A total of twenty patients with progressive malignant glioma despite surgery, radiation therapy and a first line of chemotherapy will be recruited and assigned to four dosage regimen of Sulfasalazine. This medication will be taken orally t.i.d. at a daily dose of 1.5–3–4 or 6 g, continuously until complete remission, evidence of progression or drug intolerance. Primary endpoints are drug safety in the setting of malignant gliomas and tumor response as measured according to MacDonald's criteria. An interim analysis of drug safety will be conducted after the inclusion of ten patients. The complete evaluation of primary endpoints will be conducted two years after the enrolment of the last patient or after the death of the last patient should this occur prematurely. The aim of this study is to evaluate the safety and efficacy of Sulfasalazine as a treatment for recurring malignant gliomas. The safety and efficacy of this drug are analyzed as primary endpoints. Overall survival and progression-free survival are secondary endpoint

  12. Survival benefit of hyperthermia in a prospective randomized trial of brachytherapy boost ± hyperthermia for glioblastoma multiforme

    International Nuclear Information System (INIS)

    Purpose: To determine if adjuvant interstitial hyperthermia (HT) significantly improves survival of patients with glioblastoma undergoing brain brachytherapy boost after conventional radiotherapy. Materials and Methods: Adults with newly-diagnosed, unifocal, circumscribed, supratentorial glioblastoma ≤ 5 cm in diameter were registered postoperatively on a Phase II/III prospective randomized trial (BTRC 6G-90-2) and treated with partial brain radiotherapy at 1.8 Gy per daily fraction to 59.4 Gy with oral hydroxyurea. If the tumor was still deemed to be implantable on the post-teletherapy imaging study, the patient was randomized to brachytherapy boost alone or brachytherapy boost + HT (high-activity iodine-125 temporary implants giving 60 Gy at 0.40-0.60 Gy/h ± helical coil microwave antenna interstitial HT for 30 min immediately before and after brachytherapy). Survival from diagnosis was estimated using the Kaplan-Meier method. Survival curves were compared with the log rank test. Univariate and multivariate analyses were performed using the Cox proportional hazards method. Results: >From August 1990 through August 1995, a total of 118 patients were entered on the trial, of which 111 were eligible. Patient age ranged from 21-75 years (median, 55 years) and KPS ranged from 70-100 (median, 90). Forty patients were randomized to brachytherapy (arm A) and 40 to brachytherapy + HT (arm B). Chiefly due to tumor progression, 31 patients never reached randomization. Thirty-three of 40 arm A patients and 35 of 40 arm B patients were evaluable and actually underwent brachytherapy boost and 31 evaluable arm B patients actually received HT. The median steady-state T90 was 42.1 deg. C and the median T90 thermal dose was about 12 CEM 43 deg. T90. Survival analyzed by intent to treat was significantly longer for arm B than for arm A (median survival 89 vs. 76 weeks; p = 0.055 by the log rank test). Analyzing only implanted patients, the median survival was 91 weeks for 35 arm

  13. Radiation therapy for painful heel spurs. Results of a prospective randomized study

    International Nuclear Information System (INIS)

    Purpose: to evaluate the efficacy of two different dose-fractionation schedules for radiation therapy (RT) in patients with painful heel spurs. Patients and methods: 130 patients were randomized into two groups: the low-dose (LD) group (n = 65 heels) received a total dose of 3.0 Gy given in two weekly fractions of 0.5 Gy; in the high-dose (HD) group (n = 65 heels), two weekly fractions of 1.0 Gy were applied over 3 weeks (total dose 6.0 Gy). In 24 sites of the HD group and 17 sites of the LD group, a second RT course was given. The results were assessed using a five-level function score which was documented before RT, at the end of each RT course, and at 6 weeks and 6 months thereafter. Results: at 6-month follow-up, RT led to a highly significant reduction of symptoms in both groups. In the HD group, 31 sites were classified as excellent (score: 90-100), 13 as good (score: 70-85), twelve as moderate (score: 45-65), and nine as poor (score: 0-40). In the LD group, 35 sites were classified as excellent, eight as good, ten as moderate, and twelve as poor. The comparison of the difference of the sum score and the single criteria before RT and at 6 months after RT using the Wilcoxon-Mann-Whitney U-test revealed no statistically significant difference of response to RT between both groups. Conclusion: RT is an effective treatment option for the management of inflammatory heel spurs. The dose for an RT course should not exceed 3.0 Gy. (orig.)

  14. Radiation therapy for painful heel spurs. Results of a prospective randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Heyd, R.; Tselis, N.; Roeddiger, S.J.; Zamboglou, N. [Dept. of Radiotherapy, Klinikum Offenbach (Germany); Ackermann, H. [Dept. of Biomathematics, Univ. Hospital, J.W. Goethe Univ. Frankfurt/Main (Germany)

    2007-01-15

    Purpose: to evaluate the efficacy of two different dose-fractionation schedules for radiation therapy (RT) in patients with painful heel spurs. Patients and methods: 130 patients were randomized into two groups: the low-dose (LD) group (n = 65 heels) received a total dose of 3.0 Gy given in two weekly fractions of 0.5 Gy; in the high-dose (HD) group (n = 65 heels), two weekly fractions of 1.0 Gy were applied over 3 weeks (total dose 6.0 Gy). In 24 sites of the HD group and 17 sites of the LD group, a second RT course was given. The results were assessed using a five-level function score which was documented before RT, at the end of each RT course, and at 6 weeks and 6 months thereafter. Results: at 6-month follow-up, RT led to a highly significant reduction of symptoms in both groups. In the HD group, 31 sites were classified as excellent (score: 90-100), 13 as good (score: 70-85), twelve as moderate (score: 45-65), and nine as poor (score: 0-40). In the LD group, 35 sites were classified as excellent, eight as good, ten as moderate, and twelve as poor. The comparison of the difference of the sum score and the single criteria before RT and at 6 months after RT using the Wilcoxon-Mann-Whitney U-test revealed no statistically significant difference of response to RT between both groups. Conclusion: RT is an effective treatment option for the management of inflammatory heel spurs. The dose for an RT course should not exceed 3.0 Gy. (orig.)

  15. Randomized, prospective double-blind trial of metoclopramide and placebo for gastroesophageal reflux in infants.

    Science.gov (United States)

    Tolia, V; Calhoun, J; Kuhns, L; Kauffman, R E

    1989-07-01

    The effect of metoclopramide on gastroesophageal reflux was studied in 30 infants less than 1 year of age. Gastroesophageal reflux was documented in all infants by extended pH monitoring before enrollment in the study. Patients were randomly assigned to receive metoclopramide 0.1 mg/kg or placebo four times a day, 1/2 hour before feeding for 1 week, followed by the alternate regimen for 1 week. The infants were reevaluated with extended pH monitoring and scintigraphy after 4 to 7 days of each treatment. A symptom score was derived by determining the average number of occurrences of all symptoms recorded daily by parents on a symptom checklist during pretreatment, placebo, and metoclopramide treatment periods. There was a difference between pretreatment evaluation and placebo periods with respect to daily symptom scores (p less than 0.005), reflecting a significant placebo response. However, no difference in scintigraphic study was found between placebo and metoclopramide periods. A significant difference between placebo and metoclopramide periods was noted in the percentage of time esophageal pH was less than 4.0 (p less than 0.001). However, although metoclopramide decreased the proportion of time esophageal pH was less than 4.0, pH remained less than 4.0 for more than 5% of the time in most patients. Substratification of the total group into infants younger and older than 3 months revealed that older infants had greater average daily weight gain during the metoclopramide treatment period (34.3 gm/day) than in the placebo treatment period (6.6 gm/day, p = 0.05). We conclude that metoclopramide in the dosage 0.1 mg/kg four times daily reduces reflux in infants and may be useful for infants with poor weight gain and other serious complications of gastroesophageal reflux. PMID:2661788

  16. Outpatient parenteral antimicrobial therapy in children with febrile urinary tract infection: a prospective randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Nasiri Kalmarzi R

    2009-01-01

    Full Text Available "nBackground: Acute pyelonephritis may lead to permanent renal scarring. The standard recommendation for treatment of febrile children with urinary tract infection (UTI is hospitalization for intravenous antibiotics. The purpose of this study was to compare the efficacy of outpatient intravenous ceftriaxone and cefixime versus inpatient of the same regimen for children with febrile UTI.   "nMethods: In a randomized clinical trial, we compared the efficacy of administration two days intravenous ceftriaxone followed by an oral cefixime for eight days (as outpatient group versus four days intravenous ceftriaxone followed by an oral cefixime for six days (as inpatient group, in 203 children (99 cases in outpatient group and 104 cases in inpatient group 3 months to 15 years of age with febrile UTI, in terms of short-term clinical outcomes (sterilization of the urine and defeverescence and long-term morbidity (incidence of reinfection and renal scarring documented by DMSA scintigraphy. "nResults: Repeat urine cultures were sterile within 48 hours in all children, mean time to defeverescence was 27.58 (SD=±12.62 and 31.44 (SD=±17.06 hours for children in outpatient and inpatient groups, respectively (P=0.067. Reinfection occurred in 9.1% of outpatient and 13.4% of inpatient group (P=0.326. Renal scarring developed in 11% of children of outpatient and 7.6% of children of inpatient group (P=0.884. There was no significant difference between the two groups in respect of renal scarring. "nConclusions: Outpatient ceftriaxone for two days followed by cefixime to complete a 10 days course can be recommended as a safe and effective treatment for children with febrile UTI.

  17. A prospective, randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer

    Science.gov (United States)

    Lin, Ying; Liu, Jianlun; Zhang, Xiaohua; Li, Li; Hu, Rui; Liu, Jian; Deng, Yongchuan; Chen, Dedian; Zhao, Yangbing; Sun, Shengrong; Ma, Rong; Zhao, Ying; Liu, Jinping; Zhang, Yang; Wang, Xijing; Li, Yafen; He, Pingqing; Li, Enxiao; Xu, Zheli; Wu, Yaqun; Tong, Zhongsheng; Wang, Xiaojia; Huang, Tao; Liang, Zhongxiao; Wang, Shui; Su, Fengxi; Lu, Yunfei; Zhang, Helong; Feng, Guosheng; Wang, Shenming

    2014-01-01

    Tamoxifen and anastrozole are widely used as adjuvant treatment for early stage breast cancer, but their hepatotoxicity is not fully defined. We aimed to compare hepatotoxicity of anastrozole with tamoxifen in the adjuvant setting in postmenopausal breast cancer patients. Three hundred and fifty-three Chinese postmenopausal women with hormone receptor-positive early breast cancer were randomized to anastrozole or tamoxifen after optimal primary therapy. The primary end-point was fatty liver disease, defined as a liver–spleen ratio <0.9 as determined using a computed tomography scan. The secondary end-points included abnormal liver function and treatment failure during the 3-year follow up. The cumulative incidence of fatty liver disease after 3 years was lower in the anastrozole arm than that of tamoxifen (14.6% vs 41.1%, P < 0.0001; relative risk, 0.30; 95% CI, 0.21–0.45). However, there was no difference in the cumulative incidence of abnormal liver function (24.6% vs 24.7%, P = 0.61). Interestingly, a higher treatment failure rate was observed in the tamoxifen arm compared with anastrozole and median times to treatment failure were 15.1 months and 37.1 months, respectively (P < 0.0001; HR, 0.27; 95% CI, 0.20–0.37). The most commonly reported adverse events were ‘reproductive system disorders’ in the tamoxifen group (17.1%), and ‘musculoskeletal disorders’ in the anastrozole group (14.6%). Postmenopausal women with hormone receptor-positive breast cancer receiving adjuvant anastrozole displayed less fatty liver disease, suggesting that this drug had a more favorable hepatic safety profile than tamoxifen and may be preferred for patients with potential hepatic dysfunction. PMID:24975596

  18. Brinzolamide/timolol versus dorzolamide/timolol fixed combinations: A hospital-based, prospective, randomized study

    Directory of Open Access Journals (Sweden)

    Mary S Galose

    2016-01-01

    Full Text Available Purpose: To compare the efficacy and tolerability of brinzolamide/timolol (BT and dorzolamide/timolol (DT fixed combinations on intraocular pressure (IOP reduction. Methods: Patients with primary open angle glaucoma or normal tension glaucoma were randomized to receive either BT or DT. IOPs were measured at baseline, 2 weeks, and 1, 2, and 3 months. The primary outcome measures were the mean change in IOP from baseline at each visit. Secondary outcome measures included the tolerability of each fixed combination. Results: Seventy-three patients (73 eyes were included; 37 eyes in BT group and 36 eyes in DT group. Baseline mean IOP were 24.14 ± 4.5 and 29.53 ± 6 mmHg for BT and DT, respectively (P < 0.001. Both BT and DT provided statistically significant mean IOP reductions from baseline values within each group at all study visits (P < 0.001. DT provided greater mean IOP reductions from baseline than BT at each visit which was statistically significant at 2 weeks (P = 0.037. Mean percentage of IOP reduction was 24.35% and 46.33% at 2 weeks (P < 0.001, and 24.65% and 47% at 3 months (P < 0.001 for BT and DT, respectively. Patients' tolerability appeared to be better for DT than for BT with complete ocular comfort without any ocular adverse effects in 31 patients (81.1% in DT group and 11 patients (29.7% in BT group (P < 0.001. Conclusion: Both drops provide effective IOP reduction which was greater, and patients were more likely to achieve lower target pressures with DT than with BT.

  19. CONTROLLED HYPOTENSIVE ANAESTHESIA WITH DEXMEDETOMIDINE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY: A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Sunil

    2014-08-01

    Full Text Available : OBJECTIVE: Controlled hypotension is commonly used to achieve a bloodless operative field which is needed for successful FESS. This study was carried out to assess the hypotensive effect of dexmedetomidine (DEX during FESS. METHODS: Fifty ASA grades I and II patients of either sex aged 20–50 years undergoing FESS were randomly divided into two groups of 25 each. Group D received 10–15 min prior to induction of anesthesia 1 μg/kg IV bolus DEX diluted in 10 ml of normal saline over 10 min. Immediately thereafter an infusion of 0.4 μg/kg/hr of DEX commenced. Group C received placebo bolus and infusion of saline at a rate similar to DEX in Group D. Standard anesthetic technique was used. The surgical field was assessed using Average Category Scale and average blood loss was calculated. Hemodynamic variables (MAP and HR; emergence time and total recovery from anesthesia (Aldrete score ≥9 were recorded. RESULT: Group D reached the desired MAP (55-65 mmHg. In group D patients the average MAP was 55.9±5.3 mm of Hg, where as in group C it was 86.2±11.4 mm of Hg. Patients in group D had a better surgical field, and the duration of surgery was significantly reduced(78.34±16.7mins in group D vs 103.2±113.1 mins in group C The mean awakening time was significantly reduced in patients of Group D (9.1±2.7 mins in group D vs12.8±2.2 mins in group C when compared to patients of Group C. CONCLUSION: This study demonstrated that dexmedetomidine is a safe agent for controlled hypotension and is effective in providing ideal surgical field during FESS.

  20. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial

    Directory of Open Access Journals (Sweden)

    Rinaldo Massimo

    2011-02-01

    Full Text Available Abstract Background To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Methods Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. Results From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03; patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p Conclusions In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. Trial registration ClinicalTrials.gov NCT00540800.

  1. Clinical Study on Prospective Efficacy of All-Trans Acid, Realgar-Indigo Naturalis Formula Combined with Chemotherapy as Maintenance Treatment of Acute Promyelocytic Leukemia

    Directory of Open Access Journals (Sweden)

    Li Xiang-Xin

    2014-01-01

    Full Text Available Objectives. To test the efficiency and safety of sequential application of retinoic acid (ATRA, Realgar-Indigo naturalis formula (RIF and chemotherapy (CT were used as the maintenance treatment in patients with acute promyelocytic leukemia (APL. Methods. This was a retrospective study of 98 patients with newly diagnosed APL who accepted two different maintenance treatments. After remission induction and consolidation chemotherapy according to their Sanz scores, patients received two different kinds of maintenance scheme. The first regimen was using ATRA, RIF, and standard dose of CT sequentially (ATRA/RIF/CT regimen, while the second one was using ATRA and low dose of chemotherapy with methotrexate (MTX plus 6-mercaptopurine (6-MP alternately (ATRA/CTlow regimen. The OS, DFS, relapse rate, minimal residual disease, and adverse reactions in two groups were monitored and evaluated. Results. ATRA/RIF/CT regimen could effectively reduce the chance of relapse in different risk stratification of patients, but there was no significant difference in 5-year DFS rate and OS rate between the two groups. Besides, the patients in the experimental group suffered less severe adverse reactions than those in the control group. Conclusions. The repeated sequential therapeutic regimen to APL with ATRA, RIF, and chemotherapy is worth popularizing for its high effectiveness and low toxicity.

  2. Computed Tomography (CT) Perfusion as an Early Predictive Marker for Treatment Response to Neoadjuvant Chemotherapy in Gastroesophageal Junction Cancer and Gastric Cancer - A Prospective Study

    DEFF Research Database (Denmark)

    Lundsgaard Hansen, Martin; Fallentin, Eva; Lauridsen, Carsten;

    2014-01-01

    of, and after three series of chemotherapy. The CT perfusion scans were performed using a 320-detector row scanner. Tumour volume and perfusion parameters (arterial flow, blood volume and permeability) were computed on a dedicated workstation with a consensus between two radiologists. Response to...

  3. Combined radiotherapy and chemotherapy with cyclophosphamide, adriamycin, methotrexate, procarbazine (camp) in 64 consecutive patients with epidermoid bronchogenic carcinoma, limited disease: a prospective study

    International Nuclear Information System (INIS)

    Sixty-four consecutive patients with inoperable epidermoid bronchogenic carcinoma (limited disease) were treated with radiotherapy to the primary and nodal areas and combination chemotherapy with cyclophosphamide, adriamycin, methotrexate and procarbazine. The overall response rate (CR + PR) to combined treatment was 62%. The median survival time was 12.7 months. The toxicity was acceptable and no treatment-related death occurred

  4. A Prospective, Randomized Trial in The Emergency Department Of Suggestive Audio-Therapy Under Deep Sedation for Smoking Cessation

    Directory of Open Access Journals (Sweden)

    Shah, Sushma

    2007-08-01

    Full Text Available Objectives: In a sample of patients undergoing procedural deep sedation in the emergency department (ED, we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. Methods: We asked subjects about their smoking, including desire to quit (0-10 numerical scale and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. Results: One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 ± 2.6 and mean cigarettes per day was 17.5 ± 12.1. We successfully contacted 69 (62% patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: –22.0% to 18.8%. Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: –8.7% to 35.6%. Conclusion: Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

  5. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Wu, Yung-Tsan; Ke, Ming-Jen; Chou, Yu-Ching; Chang, Chih-Ya; Lin, Ching-Yueh; Li, Tsung-Ying; Shih, Feng-Mei; Chen, Liang-Cheng

    2016-06-01

    Three recent studies demonstrated the positive effect of extracorporeal shock wave therapy (ESWT) for treating carpal tunnel syndrome (CTS). However, none have entirely proved the effects of ESWT on CTS because all studies had a small sample size and lacked a placebo-controlled design. Moreover, radial ESWT (rESWT) has not been used to treat CTS. We conducted a prospective randomized, controlled, double-blinded study to assess the effect of rESWT for treating CTS. Thirty-four enrolled patients (40 wrists) were randomized into intervention and control groups (20 wrists in each). Participants in the intervention group underwent three sessions of rESWT with nightly splinting, whereas those in the control group underwent sham rESWT with nightly splinting. The primary outcome was visual analog scale (VAS), whereas the secondary outcomes included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. Evaluations were performed before treatment and at 1, 4, 8, and 12 weeks after the third rESWT session. A significantly greater improvement in the VAS, BCTQ scores, and CSA of the median nerve was noted in the intervention group throughout the study as compared to the control group (except for BCTQ severity at week 12 and CSA at weeks 1 and 4) (p controlled trial and demonstrate that rESWT is a safe and effective method for relieving pain and disability in patients with CTS. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:977-984, 2016. PMID:26610183

  6. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    Science.gov (United States)

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury. PMID:26335108

  7. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  8. Pars plana vitrectomy versus three intravitreal injections of bevacizumab for nontractional diabetic macular edema. A prospective, randomized comparative study

    Directory of Open Access Journals (Sweden)

    Seemant Raizada

    2015-01-01

    Full Text Available Background: The aim of this study was to compare the effectiveness of pars plana vitrectomy (PPV and removal of the internal limiting membrane (ILM with three, monthly, intravitreal bevacizumab (IVB injections for refractory diabetic macular edema. Materials and Methods: This was a prospective, randomized, comparative, interventional study. Forty-four patients were enrolled and randomized in two groups. Twenty-two eyes enrolled in Group I received three IVB injections at monthly interval. Twenty-two eyes were enrolled in Group II which underwent PPV with ILM removal. The primary outcomes measured were: (1 Best corrected logMAR visual acuity (BCVA using Snellen′s visual acuity chart. (2 Central macular thickness (CMT on optical coherence tomography. The secondary outcome measures were: Complication rates like (1 progression of lens opacities, (2 high intraocular pressure needing further treatment/procedure, (3 development of vitreous hemorrhage related to the procedure employed, (4 retinal detachment and (5 severe inflammation/endophthalmitis. Results: In Group I (IVB: 3 (13.6% eyes showed no change in BCVA; 3 (13.6% eyes reported decrease in BCVA and 16 (72.8% eyes showed improvement in BCVA; (P = 0.0181. In Group II (PPV: 4 (18.2% eyes showed no change in BCVA; 5 (22.7% eyes showed decrease and 13 (59.1% eyes showed improvement in BCVA (P = 0.0281. Mean decrease in CMT in IVB group was 108.45 μ, whereas mean decrease in CMT in PPV group was 161.36 μ. No major complications were seen in either group. Conclusion: Posttreatment decrease in CMT was more in PPV group and vision improvement more in IVB group. However, no statistically significant difference between the two methods was found.

  9. Use of a sealant to prevent prolonged air leaks after lung resection: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Lequaglie Cosimo

    2012-10-01

    Full Text Available Abstract Background Pulmonary air leaks are common complications of lung resection and result in prolonged hospital stays and increased costs. The purpose of this study was to investigate whether, compared with standard care, the use of a synthetic polyethylene glycol matrix (CoSeal® could reduce air leaks detected by means of a digital chest drain system (DigiVent™, in patients undergoing lung resection (sutures and/or staples alone. Methods Patients who intraoperatively showed moderate or severe air leaks (evaluated by water submersion tests were intraoperatively randomized to receive just sutures/staples (control group or sutures/staples plus CoSeal® (sealant group. Differences among the groups in terms of air leaks, prolonged air leaks, time to chest tube removal, length of hospital stay and related costs were assessed. Results In total, 216 lung resection patients completed the study. Nineteen patients (18.1% in the control group and 12 (10.8% patients in the sealant group experienced postoperative air leaks, while a prolonged air leak was recorded in 11.4% (n = 12 of patients in the control group and 2.7% (n = 3 of patients in the sealant group. The difference in the incidence of air leaks and prolonged air leaks between the two groups was statistically significant (p = 0.0002 and p = 0.0013. The mean length of hospital stay was significantly shorter in the sealant group (4 days than the control group (8 days (p = 0.0001. We also observed lower costs in the sealant group than the control group. Conclusion The use of CoSeal® may decrease the occurrence and severity of postoperative air leaks after lung resection and is associated with shorter hospital stay. Trial registration Not registered. The trial was approved by the Institutional Review Board of the IRCCS-CROB Basilicata Regional Cancer Institute, Rionero in Vulture, Italy.

  10. A Randomized Prospective Study Of The Use Of Ipads In Reducing Anxiety During Cast Room Procedures

    Science.gov (United States)

    Ko, Justine S.; Whiting, Zachariah; Nguyen, Cynthia; Liu, Raymond W; Gilmore, Allison

    2016-01-01

    Background Cast room procedures can be a source of anxiety for children. Various techniques, including music therapy, have been evaluated as a way to ease this anxiety. The use of iPads as a form of distraction during cast room procedures has not previously been evaluated and was the purpose of the current study. Methods 146 children and adolescents who underwent cast room procedures during June- August 2015 were randomly assigned to one of three groups: no-iPad, iPad with video, or iPad with game. Patient heart rates were measured using a pulse oximeter in the waiting room, before the procedure, during the procedure, and after the procedure. Mean values for each group were calculated at each time interval and compared both between groups and within groups over time. Results There were no significant differences in baseline (waiting room) heart rate between the no-iPad and iPad groups. When compared with the no-iPad group, there was a trend toward decreased heart rate in the video group (p=0.13) and a significant increase in heart rate in the game group (p=0.026) before the procedure. There were no significant decreases in heart rate within any of the groups when comparing the waiting room heart rates with the during procedure heart rates. There was a significant difference between the no-iPad and video groups (p=0.047) when comparing the change in heart rate from baseline to before the procedure, with a decreased heart rate observed in the video group. Conclusions The results of this study show a significant decrease in heart rate when transitioning from the waiting room to the cast room while watching videos on the iPad. iPad-based video delivery appears to decrease anxiety prior to cast room procedures. iPad-based game play is difficult to assess as elevations in heart rate prior to the procedure are presumed to be related to game play and confound the observed effect it may have on anxiety related to the procedure.

  11. One-site versus two-site phacotrabeculectomy: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Moschos MM

    2015-08-01

    Full Text Available Marilita M Moschos,1 Irini P Chatziralli,2 Michael Tsatsos3 1First Department of Ophthalmology, University of Athens, 2Second Department of Ophthalmology, Ophthalmiatrion Athinon, Athens, Greece; 3Department of Ophthalmology, Cambridge University Hospital NHS, Cambridge, UK Purpose: The purpose of this study is to compare the efficacy and safety of one-site and two-site combined phacotrabeculectomy with foldable posterior chamber intraocular lens implantation.Methods: Thirty-four patients (41 eyes with glaucoma and cataract were randomly assigned to undergo either a one-site (22 eyes or a two-site (19 eyes combined procedure. One-site approach consisted of a standard superior phacotrabeculectomy with a limbus-based conjunctival flap, while two-site approach consisted of a clear cornea phacoemulsification and a separate superior trabeculectomy with a limbus-based conjunctival flap.Results: Mean follow-up period was 54 months (standard deviation [SD] 2.3. Mean preoperative intraocular pressure (IOP in the one-site group was 21.3 mmHg (SD 2.8 and in the two-site group was 21.8 mmHg (SD 3.0 (P>0.1. Mean postoperative IOP significantly decreased in both groups compared to the preoperative level and was 15.6 mmHg (SD 3.5 in the one-site group and 14.9 mmHg (SD 2.7 in the two-site group. Three months later, the difference between the two groups was not statistically significant (P=0.058. The one-site group required significantly more medications than the two-site group (P=0.03. Best-corrected visual acuity (BCVA improved similarly in both groups, but there was less postoperative (induced astigmatism in the two-site group in a marginal statistical level (P=0.058. Intra- and postoperative complications were comparable in the two groups.Conclusion: Both techniques yielded similar results concerning final BCVA and IOP reduction. However, the two-site group had less induced astigmatism and a better postoperative IOP control with less required

  12. Topical Calendula and Betamethasone Valerate in the prevention of acute radiation dermatitis: a randomized prospective trial

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    Fotouhi M

    2007-07-01

    Full Text Available Background: Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications. Methods: This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups: one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment (30, and the other received the new treatment, 0.1% calendula ointment (30. All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications. Results: The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was: 0, 6.7%; I, 73.3%; II, 16

  13. Prospective randomized comparison of oral sodium phosphate and polyethylene glycol lavage for colonoscopy preparation

    Institute of Scientific and Technical Information of China (English)

    Kai-Lin Hwang; William Tzu-Liang Chen; Koung-Hong Hsiao; Hong-Chang Chen; Ting-Ming Huang; Chien-Ming Chiu; Ger-Haur Hsu

    2005-01-01

    AIM: To compare the effectiveness, patient acceptability, and physical tolerability of two oral lavage solutions prior to colonoscopy in a Taiwanese population. METHODS: Eighty consecutive patients were randomized to receive either standard 4 L of polyethylene glycol (PEG) or 90 mL of sodium phosphate (NaP) in a split regimen of two 45 mL doses separated by 12 h, prior to colonoscopic evaluation. The primary endpoint was the percent of subjects who had completed the preparation. Secondary endpoints included colonic cleansing evaluated with an overall assessment and segmental evaluation, the tolerance and acceptability assessed by a selfadministered structured questionnaire, and a safety profile such as any unexpected adverse events, electrolyte tests, physical exams, vital signs, and body weights. RESULTS: A significantly higher completion rate was found in the NaP group compared to the PEG group(84.2% vs 27.5%, P<0.001). The amount of fluid suctioned was significantly less in patients taking NaP vs PEG (50.13±54.8 cc vs 121.13±115.4 cc, P<0.001),even after controlling for completion of the oral solution(P = 0.031). The two groups showed a comparable overall assessment of bowel preparation with a rate of "good" or "excellent" in 78.9% of patients in the NaPgroup and 82.5% in PEG group (P = 0.778). Patients taking NaP tended to have significantly better colonic segmental cleansing relative to stool amount observedin the descending (94.7% vs 70%, P = 0.007) andtransverse (94.6% vs 74.4%, P = 0.025) colon. Slightly more patients graded the taste of NaP as "good" or "very good" compared to the PEG patients (32.5% vs 12.5%;P = 0.059). Patients' willingness to take the same preparation in the future was 68.4% in the NaP compared to 75% in the PEG group (P = 0.617). There was a significant increase in serum sodium and a significant decrease in phosphate and chloride levels in NaP group on the day following the colonoscopy without any clinical sequelae. Prolonged (

  14. High incidence of microsatellite instability and loss of heterozygosity in three loci in breast cancer patients receiving chemotherapy: a prospective study

    International Nuclear Information System (INIS)

    The aim of the study was to evaluate potential chemotherapy-induced microsatellite instability, loss of heterozygosity, loss of expression in mismatch repair proteins and associations with clinical findings in breast cancer patients, especially resistance to chemotherapy and/or development of other tumors in the four years following chemotherapy treatment. A comprehensive study of chemotherapy-related effects with a follow-up period of 48 months post treatment was conducted. A total of 369 peripheral blood samples were collected from 123 de novo breast cancer patients. Microsatellite instability and loss of heterozygosity in five commonly used marker loci (including Tp53-Alu of the tumor suppressor gene TP53) were analyzed in blood samples. Sampling was conducted on three occasions; 4–5 weeks prior to the first chemotherapy session (pre-treatment), to serve as a baseline, followed by two consecutive draws at 12 weeks intervals from the first collection. Mismatch repair protein expression was evaluated in cancer tissues using immunohistochemistry for three mismatch-repair related proteins. A total of 70.7% of the patients showed microsatellite instability for at least one locus, including 18.6% marked as high-positive and 52.1% as low-positive; 35.8% showed loss of heterozygosity in addition to microsatellite instability, while 29.3% exhibited microsatellite stability. The following incidence rates for microsatellite instability and loss of heterozygosity were detected: 39.1% positive for Tp53-Alu, 31.1% for locus Mfd41, and 25.3% for locus Mfd28. A higher occurrence of loss of heterozygosity was noted with alleles 399 and 404 of Tp53-Alu. The mismatch repair protein expression analysis showed that the chemotherapy caused a loss of 29.3% in hMLH1 expression, and 18.7% and 25.2% loss in hMSH2 and P53 expression, respectively. A strong correlation between low or deficient hMSH2 protein expression and occurrence of mismatch repair/loss of heterozygosity events in Mfd

  15. Anticancer chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Weller, R.E.

    1988-10-01

    Despite troubled beginnings, anticancer chemotherapy has made significant contribution to the control of cancer in man, particularly within the last two decades. Early conceptual observations awakened the scientific community to the potentials of cancer chemotherapy. There are now more than 50 agents that are active in causing regression of clinical cancer. Chemotherapy's major conceptual contributions are two-fold. First, there is now proof that patients with overt metastatic disease can be cured, and second, to provide a strategy for control of occult metastases. In man, chemotherapy has resulted in normal life expectancy for some patients who have several types of metastatic cancers, including choriocarcinoma, Burkitt's lymphomas, Wilm's tumor, acute lymphocytic leukemia, Hodgkins disease, diffuse histiocytic lymphoma and others. Anticancer chemotherapy in Veterinary medicine has evolved from the use of single agents, which produce only limited remissions, to the concept of combination chemotherapy. Three basic principles underline the design of combination chemotherapy protocols; the fraction of tumor cell killed by one drug is independent of the fraction killed by another drug; drugs with different mechanisms of action should be chosen so that the antitumor effects will be additive; and since different classes of drugs have different toxicities the toxic effects will not be additive.

  16. Core Decompression and Autologous Bone Marrow Concentrate for Treatment of Femoral Head Osteonecrosis: A Randomized Prospective Study

    Science.gov (United States)

    Pepke, Wojciech; Kasten, Philip; Beckmann, Nicholas A.; Janicki, Patricia; Egermann, Marcus

    2016-01-01

    The aim of this study was to investigate the safety of injection of bone marrow aspirate concentrate during core decompression and to study its clinical (visual analogue scale; Harris-Hip-score) and radiological outcomes (magnetic resonance imaging). In this prospective and randomized clinical trial we evaluated 24 consecutive patients with non-traumatic femoral head necrosis (FHN) during a period of two years after intervention. In vitro analysis of mesenchymal stem cells was performed by evaluating the fibroblast colony forming units (CFU-Fs). Postoperatively, significant decrease in pain associated with a functional benefit lasting was observed. However, there was no difference in the clinical outcome between the two study groups. Over the period of two years there was no significant difference between the head survival rate between both groups. In contrast to that, we could not perceive any significant change in the volume of FHN in both treatment groups related to the longitudinal course after treating. The number of CFU showed a significant increase after centrifugation. This trial could not detect a benefit from the additional injection of bone marrow concentrate with regard to bone regeneration and clinical outcome in the short term. PMID:27114808

  17. High- versus low-top shoes for the prevention of ankle sprains in basketball players. A prospective randomized study.

    Science.gov (United States)

    Barrett, J R; Tanji, J L; Drake, C; Fuller, D; Kawasaki, R I; Fenton, R M

    1993-01-01

    Using a prospective, randomized experimental design, 622 college intramural basketball players were stratified by a previous history of ankle sprains to wear a new pair of either high-top, high-top with inflatable air chambers, or low-top basketball shoes during all games for a complete season. Subjects were asked to complete a history questionnaire and were given a complete ankle examination. They were allowed to wear these shoes only during basketball competition. Followed over the course of a 2-month intramural season, 15 ankle injuries occurred during 39,302 minutes of player-time: 7 in high-top shoes, 4 in low-top shoes, and 4 in high-top shoes with inflatable air chambers. The injury rates (injuries per player-minute) were 4.80 x 10(-4) in high-top shoes, 4.06 x 10(-4) in low-top shoes, and 2.69 x 10(-4) in high-top shoes with inflatable air chambers. There was no significant difference among these 3 groups, leading to the conclusion that there is no strong relationship between shoe type and ankle sprains. PMID:8368420

  18. The Impact of Antibiotics on Co-morbidities Post Tonsillectomy: A Prospective, Double-Blind, Randomized Study

    Directory of Open Access Journals (Sweden)

    Amal Al Abdulla

    2015-07-01

    Full Text Available Background: Adenotonsillectomy is one of the most frequent operations performed in hospitals worldwide. The aim this study is to investigate further the impact of antibiotics on co-morbidities post tonsillectomy. Methods: This prospective double blinded randomized controlled study was conducted at the department of otolaryngology in a tertiary care hospital where 300 tonsillectomy operations are performed each year. All Patients aged 2 years and older who were admitted for elective tonsillectomy from January 2012 to December 2012 were included in this study. Results: From the 128 patients enrolled in the study, 70 belonged to Group A (Intervention and 50 to Group 2 (Control. There was no statistically significant difference in the post-operative oral intake, fever in the first post operative day, degree of stress, secondary bleeding, otalgia, fever at home, and day of return to regular diet between the two groups. Conclusion: Although some studies showed that antibiotic use was beneficial in reducing morbidities post tonsillectomy, it is advisable for otolaryngologist to re- evaluate current practice taking into consideration bacterial resistance to antibiotics, adverse effects and cost benefit ratios. The use of antibiotics in post tonsillectomy patients will remain crucial in some selected cases.

  19. A prospective, randomized comparison of intravitreal triamcinolone acetonide versus intravitreal bevacizumab (avastin in diffuse diabetic macular edema

    Directory of Open Access Journals (Sweden)

    Shahin Maha

    2010-01-01

    Full Text Available Purpose: To compare the functional and anatomical outcomes following intravitreal triamcinolone acetonide vs. intravitreal bevacizumab (Avastin treatment for diffuse diabetic macular edema. Materials and Methods: In this prospective, randomized study, subjects were divided into two groups: 24 eyes that received intravitreal injection of 4 mg/0.1 mL triamcinolone acetonide (IVTA group and 24 eyes received intravitreal injection of 1.25 mg/0.05 mL bevacizumab (IVB group. Changes in best corrected visual acuity (BCVA, intraocular pressure (IOP, baseline fluorescein angiography and optical coherence tomography measurements were evaluated in both groups. Follow-up visits out to three months from baseline are reported. Results: One month after treatment, baseline foveal thickness decreased from 452 μ to 299 μ in the IVTA group and from 292 μ to 270 μ in the IVB group. BCVA increased by two or more lines in 58.3% of eyes in the IVTA group and there was no similar improvement in the IVB group. In the IVTA group, a transient increase in IOP (27-43 mmHg occurred in four cases (16.7%, which was successfully controlled with topical medications. There were no complications in the IVB group. Conclusion: Short term outcomes indicate that intravitreal injection of bevacizumab was not associated with surgical complications compared to triamcinolone acetonide. Triamcinolone acetonide appears to be more effective treatment for diabetic macular edema than bevacizumab.

  20. Prevention of heterotopic ossification after total hip replacement. Using nonsteroidal antiinflammatory drugs versus radiation therapy: a prospective randomized trial

    International Nuclear Information System (INIS)

    Purpose: Two prospective trials were undertaken to assess the comparative efficacy of early postoperative irradiation with different radiation doses versus the postoperative use of nonsteroidal antiinflammatory drugs (NSAID) for prevention of heterotopic ossification (HO) following prothetic total hip replacement (THP). Patients and Method: Between 1992 and 1994 585 patients received THP. These patients were randomized in two longitudinal studies each with 3 treatment arms comparing postoperative irradiation with 4x3 Gy (101 patients), 1x5 Gy (93 patients), 1x7 Gy (95 patients) and the postoperative use of the NSAID indometacin for 7 days (113 patients) respectively for 14 days (90 patients) and acetyl salicyl acid (ASS) for 14 days (93 patients). Heterotopic ossification was scored according to the Brooker grading system. One hundred patients receiving no prophylactic therapy after total hip arthroplasty between 1988 and 1992 were analysed and defined as historical control group. Conclusion: Prophylactic irradiation of the operative site after hip replacement is more effective than the use of NSAID. Because no significant difference between the fractionated single dose irradiation was found and the latter is more comfortable for patients and more economical, irradiation with single 7 Gy fraction should be prefered. (orig./MG)

  1. Efficacy and safety of ecabet sodium on functional dyspepsia :A prospective, double-blinded, randomized, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    Jun Haeng Lee; Soo Teik Lee; Eun Hyun Lee; Jong Chul Rhee; Jae J Kim; Ki-Baik Hahm; Dong Ho Lee; Nayoung Kim; Sung Kook Kim; Jong Jae Park; Seok Reyol Choi; Jong Hun Lee

    2006-01-01

    AIM: To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia.METHODS: We performed a multi-center, prospective,randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-Ⅱ criteria were enrolled from 7 centers. In the study group (115 patients), 1.5 g ecabet sodium was given twice a day. In the control group (121 patients),400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3,14, and 28 d after initiating the treatment.RESULTS: Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment,the rates of improvement in patients with dyspeptic symptoms were not different between two groups (77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P > 0.05). Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups.There was no clinically significant adverse event in both groups.CONCLUSION: In patients with functional dyspepsia,ecabet sodium has similar clinical efficacy with cimetidine.

  2. Chemotherapy and Your Mouth

    Science.gov (United States)

    ... Health > Chemotherapy and Your Mouth Chemotherapy and Your Mouth Main Content Are You Being Treated With Chemotherapy ... Back to Top How Does Chemotherapy Affect the Mouth? Chemotherapy is the use of drugs to treat ...

  3. Accelerated radiotherapy and concomitant high dose chemotherapy in non resectable stage IV locally advanced HNSCC: Results of a GORTEC randomized trial

    International Nuclear Information System (INIS)

    Background: The objective was to evaluate the efficacy of a strong increase of the dose-intensity of concomitant radio-chemotherapy (RT-CT) in patients with far advanced non metastatic HNSCC. Methods: Eligible patients had N3 disease (UICC 1997) and the primary tumor and/or the node(s) had to be strictly unresectable. Patients with palpable N2B-C were also eligible if massive nodal involvement was present. 109 patients were included, with 53 randomized to RT-CT and 56 to accelerated RT. In the RT-CT arm, the RT regimen consisted of 64 Gy in 5 weeks and the CT regimen consisted of synchronous CDDP 100 mg/m2 on days 2, 16, and 30 and 5FU 1000 mg/m2 on days1-5 and 29-33 of the RT course. After RT-CT, two adjuvant cycles of CDDP-5FU were delivered in good responders. A control arm was using a very accelerated RT, delivering 64 Gy in 3 weeks. Results: The most common tumor sites were oropharynx and hypopharynx. Most of the patients had T4 disease (70%) and 100% had a massive nodal involvement (mainly N3 with a mean nodal size >7 cm in both arms). A significant difference was observed in favor of the RT-CT arm (p = 0.005) in terms of cumulative incidence of local regional failure or distant metastases. However, the overall survival and event free survival rates were not significantly different between the two arms (p = 0.70 and 0.16, respectively). The lack of survival benefit in favor of the RT-CT was partly due to an excess of initial early treatment related death in the RT-CT arm. Conclusion: The very intense RT-CT schedule was more efficient on disease control, but was also more toxic than accelerated RT alone, pointing out that there was no clear improvement of the therapeutic index. This study shows the limits of dose-intensification, with regard to concomitant RT-CT.

  4. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  5. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Science.gov (United States)

    2011-01-01

    Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning). Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation, radiological consolidation

  6. Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

    Science.gov (United States)

    Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

    2012-11-01

    Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

  7. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial

    Directory of Open Access Journals (Sweden)

    Paajanen Hannu

    2013-02-01

    Full Text Available Abstract Background Although the standard treatment of acute appendicitis (AA consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. Methods/design The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy. Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale. A maximum of 610 adult patients (aged 18–60 years with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day for three days continued by oral levofloxacin (500 mg per day plus metronidazole (1.5 g per day for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. Discussion The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75–85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary

  8. Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study

    International Nuclear Information System (INIS)

    The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV

  9. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus ≥10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial

    International Nuclear Information System (INIS)

    Several studies have shown that darbepoetin alfa, an erythropoiesis-stimulating agent (ESA), can reduce transfusions and increase hemoglobin (Hb) levels in patients with chemotherapy-induced anemia (CIA). Recent safety concerns, however, have prompted changes to ESA product information. In the European Union and United States, ESA therapy initiation for CIA is now recommended at a Hb level ≤10 g/dL. The present exploratory analysis examined how ESA initiation at this Hb level may impact patient care. Data from a phase 3 randomized trial were retrospectively reanalyzed. CIA patients with nonmyeloid malignancies were randomized 1:1 to 500 mcg darbepoetin alfa every three weeks (Q3W) or 2.25 mcg/kg darbepoetin alfa weekly (QW) for 15 weeks. A previously published report from this trial showed Q3W dosing was non-inferior to QW dosing for reducing transfusions from week 5 to end-of-the-treatment period (EOTP). In the present analysis, outcomes were reanalyzed by baseline Hb <10 g/dL and ≥10 g/dL. Endpoints included transfusion rates, Hb outcomes, and safety profiles. This study reanalyzed 351 and 354 patients who initiated ESA therapy at a baseline Hb of <10 g/dL or ≥10 g/dL, respectively. From week 5 to EOTP, the estimated Kaplan-Meier transfusion incidence (Q3W vs QW) was lower in the ≥10 g/dL baseline-Hb group (14% vs 21%) compared with the <10 g/dL baseline-Hb group (36% vs 41%). By week 5, the ≥10 g/dL baseline-Hb group, but not the <10 g/dL baseline-Hb group, achieved a mean Hb ≥11 g/dL. The Kaplan-Meier estimate of percentage of patients (Q3W vs QW) who achieved Hb ≥11 g/dL from week 1 to EOTP was 90% vs 85% in the ≥10 g/dL baseline-Hb group and 54% vs 57% in the <10 g/dL baseline-Hb group. Both baseline-Hb groups maintained mean Hb levels <12 g/dL and had similar safety profiles, though more patients in the ≥10 g/dL baseline-Hb group reached the threshold Hb of ≥13 g/dL. In this exploratory analysis, darbepoetin alfa Q3W and QW raised Hb

  10. Multi-Institution Prospective Trial of Reduced-Dose Craniospinal Irradiation (23.4 Gy) Followed by Conformal Posterior Fossa (36 Gy) and Primary Site Irradiation (55.8 Gy) and Dose-Intensive Chemotherapy for Average-Risk Medulloblastoma

    International Nuclear Information System (INIS)

    Purpose: Limiting the neurocognitive sequelae of radiotherapy (RT) has been an objective in the treatment of medulloblastoma. Conformal RT to less than the entire posterior fossa (PF) after craniospinal irradiation might reduce neurocognitive sequelae and requires evaluation. Methods and Materials: Between October 1996 and August 2003, 86 patients, 3-21 years of age, with newly diagnosed, average-risk medulloblastoma were treated in a prospective, institutional review board-approved, multi-institution trial of risk-adapted RT and dose-intensive chemotherapy. RT began within 28 days of definitive surgery and consisted of craniospinal irradiation (23.4 Gy), conformal PF RT (36.0 Gy), and primary site RT (55.8 Gy). The planning target volume for the primary site included the postoperative tumor bed surrounded by an anatomically confined margin of 2 cm that was then expanded with a geometric margin of 0.3-0.5 cm. Chemotherapy was initiated 6 weeks after RT and included four cycles of high-dose cyclophosphamide, cisplatin, and vincristine. Results: At a median follow-up of 61.2 months (range, 5.2-115.0 months), the estimated 5-year event-free survival and cumulative incidence of PF failure rate was 83.0% ± 5.3% and 4.9% ± 2.4% (± standard error), respectively. The targeting guidelines used in this study resulted in a mean reduction of 13% in the volume of the PF receiving doses >55 Gy compared with conventionally planned RT. The reductions in the dose to the temporal lobes, cochleae, and hypothalamus were statistically significant. Conclusion: This prospective trial has demonstrated that irradiation of less than the entire PF after 23.4 Gy craniospinal irradiation for average-risk medulloblastoma results in disease control comparable to that after treatment of the entire PF

  11. Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial

    OpenAIRE

    Simsarian JP; Saunders C.; Smith DM

    2011-01-01

    James P Simsarian, Carol Saunders, D Michelle SmithNeurology Center of Fairfax Ltd, Fairfax, VA, USABackground: Despite over 50 years of experience with adrenocorticotropic hormone (ACTH) as a treatment for acute exacerbations of multiple sclerosis, there have been no trials examining the options of the 2–3-week dosing regimen or intramuscular injection protocol used in the original trials. At our clinic, we performed a small, prospective, randomized pilot study to examine the effic...

  12. Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

    OpenAIRE

    Duara Rajnish; Misra Manoranjan; Bhuyan Ritwick; Sarma P; Jayakumar Karunakaran

    2008-01-01

    Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB) circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG) and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomi...

  13. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial

    OpenAIRE

    Ehlken, Nicola; Lichtblau, Mona; Klose, Hans; Weidenhammer, Johannes; Fischer, Christine; Nechwatal, Robert; Uiker, Sören; Halank, Michael; Olsson, Karen; Seeger, Werner; Gall, Henning; Rosenkranz, Stephan; Wilkens, Heinrike; Mertens, Dirk; Seyfarth, Hans-Jürgen

    2016-01-01

    AIMS: The impact of exercise training on the right heart and pulmonary circulation has not yet been invasively assessed in patients with pulmonary hypertension (PH) and right heart failure. This prospective randomized controlled study investigates the effects of exercise training on peak VO2/kg, haemodynamics, and further clinically relevant parameters in PH patients. METHODS AND RESULTS: Eighty-seven patients with pulmonary arterial hypertension and inoperable chronic thrombo-embolic PH (...

  14. Comparison of standard 4-row versus 6-row3-D linear cutter stapler in creation of gastrointestinal system anastomoses: a prospective randomized trial

    OpenAIRE

    Alper Sozutek; Tahsin Colak; Ahmet Dag; Tolga Olmez

    2012-01-01

    OBJECTIVE: This prospective study was conducted to compare the clinical outcomes of a 6-row 3-D linear cutter with the standard 4-row linear cutter in patients who underwent elective gastrointestinal surgery anastomosis. METHOD: Patients who underwent elective open gastrointestinal surgery that included stapled anastomosis using a linear cutter (Proximate®, Ethicon Endo-Surgery, Cincinnati, OH) between January 2011 and May 2011 were included in the study. The patients were randomly assigned t...

  15. Crinone Gel for Luteal Phase Support in Frozen-Thawed Embryo Transfer Cycles: A Prospective Randomized Clinical Trial in the Chinese Population

    OpenAIRE

    Wang, Yang; He, Yaqiong; Zhao, Xiaoming; Ji, Xiaowei; Hong, Yan; Wang, Yuan; Zhu, Qinling; Xu, Bin; Sun, Yun

    2015-01-01

    To compare Crinone vaginal progesterone gel with intramuscularly injected progesterone for luteal phase support in progesterone-supplemented frozen-thawed embryo transfer (FET) cycles, a randomized prospective study of patients qualified for FET was conducted between September 2010 and January 2013 at a hospital in Shanghai, China. From the day of transformation into secretory phase endometrium (day 0), Crinone vaginal gel (90 mg/d) was administered to patients in the Gel Group, while progest...

  16. Randomized, Prospective, Three-Arm Study to Confirm the Auditory Safety and Efficacy of Artemether-Lumefantrine in Colombian Patients with Uncomplicated Plasmodium falciparum Malaria

    OpenAIRE

    Carrasquilla, Gabriel; Barón, Clemencia; Monsell, Edwin M; Cousin, Marc; Walter, Verena; Lefèvre, Gilbert; Sander, Oliver; Fisher, Laurel M.

    2012-01-01

    The safety of artemether-lumefantrine in patients with acute, uncomplicated Plasmodium falciparum malaria was investigated prospectively using the auditory brainstem response (ABR) and pure-tone thresholds. Secondary outcomes included polymerase chain reaction-corrected cure rates. Patients were randomly assigned in a 3:1:1 ratio to either artemether-lumefantrine (N = 159), atovaquone-proguanil (N = 53), or artesunate-mefloquine (N = 53). The null hypothesis (primary outcome), claiming that t...

  17. Treatment of Alzheimer's Disease with Repetitive Transcranial Magnetic Stimulation Combined with Cognitive Training: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

    OpenAIRE

    Lee, Juyoun; Choi, Byong Hee; Oh, Eungseok; Sohn, Eun Hee; Lee, Ae Young

    2015-01-01

    Background and Purpose Repetitive transcranial magnetic stimulation (rTMS) has been examined as a potential treatment for many neurological disorders. High-frequency rTMS in particular improves cognitive functions such as verbal fluency and memory. This study explored the effect of rTMS combined with cognitive training (rTMS-COG) on patients with Alzheimer's disease (AD). Methods A prospective, randomized, double-blind, placebo-controlled study was performed with 27 AD patients (18 and 8 in t...

  18. Comparison of intravitreal bevacizumab, intravitreal triamcinolone acetonide, and macular grid augmentation in refractory diffuse diabetic macular edema: A prospective, randomized study

    OpenAIRE

    Rajvardhan Azad; Siddarth Sain; Yog Raj Sharma; Deepankur Mahajan

    2012-01-01

    Background: In spite of laser being the gold standard treatment for Diabetic Macular edema (DME), some patients do not respond to laser. Various treatment modalities are being tried in the management of refractory diffuse DME (DDME). Purpose: To compare the efficacy of intravitreal bevacizumab (IVB), intravitreal triamcinolone acetonide (IVTA), and macular grid augmentation in the management of refractory DDME. Settings and Design: Prospective randomized study in a tertiary eye care ce...

  19. PROSPECTIVE RANDOMIZED TRIAL OF EFFICACY AND SAFETY OF IODOPOVIDONE VS OXYTETRACYCLINE FOR PLEURODESIS IN SPONTANEOUS PNEUMOTHORAX AND RECURRENT PLEURAL EFFUSIONS

    Directory of Open Access Journals (Sweden)

    Uday C

    2016-02-01

    Full Text Available BACKGROUND Recurrent malignant pleural effusion and spontaneous pneumothorax can be treated by a procedure called pleurodesis by which the pleural space is obliterated. This can be done by surgical means using mechanical force or by introducing any one of the recommended agents into the pleural space via tube thoracostomy or during thoracoscopy. Examples of agents used are talc as powder or as slurry, tetracycline derivatives, antineoplastic agents (Bleomycin, mitoxantrone, quinacrine, silver nitrate, Corynebacterium parvum and iodopovidone. The aim of the present study was to evaluate the safety and efficacy of iodopovidone as a sclerosing agent in the treatment of recurrent pleural effusion and spontaneous pneumothorax. This was a randomized prospective interventional study comparing iodopovidone with oxytetracycline as the latter is now sparingly available for clinical use. MATERIAL AND METHODS Study was conducted in 44 patients above 12 years of age, admitted in the Dept. of Pulmonary Medicine, Goa Medical College. Patients with a diagnosis of spontaneous pneumothorax or recurrent malignant pleural effusion were randomly allocated to either iodopovidone or oxytetracycline group and pleurodesis was done as per British Thoracic Society Guidelines (BTS. 1 RESULTS Among 44 patients 23 were secondary spontaneous pneumothorax, 9 were primary spontaneous pneumothorax and 12 were malignant pleural effusion; 2 patients did not report for follow-up visits and the remaining 42 patients were followed up for 6 months. The success rate of oxytetracycline and iodopovidone pleurodesis is 81% and 95.2% respectively. All the patients had chest pain of varying severity during the procedure in either groups; 8 patients in oxytetracycline group and 6 patients in iodopovidone group had fever after the procedure; 2 patients in iodopovidone group developed hypotension after the procedure and there was no mortality in either group attributable to the procedure

  20. Radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia guided by magnetic navigation system: a prospective randomized comparison with conventional procedure

    Institute of Scientific and Technical Information of China (English)

    ZHANG Yu-xiao; LU Cai-yi; XUE Qiao; LI Ke; YAN Wei; ZHOU Sheng-hua

    2012-01-01

    Background Atrioventricular nodal reentrant tachycardia (AVNRT) is one of the most common paroxysmal supraventricular tachyarrhythmias.The aim of the study was to prospectively compare the characteristics of radiofrequency catheter ablation of AVNRT guided by a magnetic navigation system with the conventional procedure.Methods Patients with AVNRT diagnosed by electrophysiological tests were randomized into two groups.In the conventional technique group (CMT),a common 4-mm-tip quadrapolar temperature-controlled ablation catheter was used. In the magnetic navigation system guidance group (MNS), a magnetic 4-mm-tip quadrapolar temperature-controlled ablation catheter was used.The following parameters were collected and compared between the two groups: ablation procedure time,patient fluoroscopy time,operator fluoroscopy time,energy delivery numbers,maximal energy per deployment,success rate,complication rate and operative cost.Results Forty patients were enrolled and randomized into CMT and MNS groups.The age,gender,tachycardia history and basic cardiovascular diseases of the two groups were comparable (P >0.05).All procedures were conducted successfully without complications.No tachycardia recurred during the follow-up period of (9.3±2.6) months.In the MNS group,the patient and operator fluoroscopy times ((11.5±4.3) min,(4.2±1.5) min),energy delivery numbers (3.2±0.9),and maximal energy per deployment ((16.9±3.4) W) were shorter or lower than those of the CMT group ((14.3±6.2) min,(13.6±3.5) min,6.3±2.1,(23.7±1.3) W,respectively) (P <0.05).But the operative cost for the MNS group was higher than that of the CMT group (P <0.01 ).Conclusion Magnetic navigation system guided radiofrequency catheter ablation of AVNRT has the advantages of shorter fluoroscopy time and lower energy delivery numbers and maximal energy per deployment compared to the present conventional ablation technique.

  1. Impact of outpatient clinic ultrasound imaging in the diagnosis and treatment for shoulder impingement: a randomized prospective study.

    LENUS (Irish Health Repository)

    Saeed, Aamir

    2013-11-05

    The use of musculoskeletal ultrasonography (MSUS) in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer-term outcome and larger sample size. This randomized prospective study assessed whether clinic-based MSUS can significantly improve diagnostic accuracy in shoulder pain and whether MSUS-guided shoulder injection results in improved long-term outcomes. One hundred consecutive patients with 125 painful shoulders were recruited. Patients were randomized to receive either sonographic assessment with consequent palpation-guided injection (Group 1, n = 66) or sonographic assessment with a MSUS-guided injection of 40 mg of methylprednisolone acetate (Group 2, n = 59). A blinded rheumatologist (ADF) performed clinical assessments at baseline, 6 and 12 weeks including shoulder function tests (SFTs) (Hawkins-Kennedy test, supraspinatus tendon tenderness), physician global assessment (PGA) and patient visual analogue scores (VAS) for pain (0-10). Eighty patients with 90 symptomatic shoulders completed 12-week follow-up. Twenty patients, 11 (20 shoulders) from the palpation-guided group and 9 (15 shoulders) from the MSUS-guided group, were excluded at 6 weeks either due to requirement for repeat injection or due to surgical referral. Mean age for patients was 57.7 years, and 65 % patients were female; mean shoulder pain duration was 18 weeks (range 14-22 weeks). SFTs, patient VAS and PGA scores for pain improved significantly from baseline in both groups with significantly greater improvements in the MSUS-guided group (44 shoulders) compared to the palpation-guided group (46 shoulders) in all parameters at 6 (p < 0.01) and 12 weeks (p < 0.05). The use of MSUS in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer

  2. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    International Nuclear Information System (INIS)

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  3. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Department of Radiation Oncology

    2012-12-15

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 {+-} 23.7 and 53.2 {+-} 21.8 (p = 0.158), 38.2 {+-} 26.1 and 34.0 {+-} 24.5 (p = 0.189), and 33.0 {+-} 27.2 and 23.7 {+-} 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 {+-} 3.0 and 9.5 {+-} 2.7 (p = 0.309), 6.1 {+-} 3.6 and 5.4 {+-} 3.6 (p = 0.096), 5.3 {+-} 3.7 and 4.1 {+-} 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  4. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations

    Directory of Open Access Journals (Sweden)

    Hu HY

    2014-06-01

    Full Text Available Hongyu Hu, Qiang Fu, Wei Chen, Dezhao Wang, Xu Hua, Buxing Chen Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, People’s Republic of ChinaBackground: The efficacy of coronary angiography may be different in the right radial approach (RRA and the left radial approach (LRA due to more common vascular tortuosity in the RRA. The aim of the study was to determine whether LRA is a valid alternative for coronary angiography compared with RRA in Asian populations. Methods: This is a single-center, prospective, randomized controlled study. A total of 1,400 consecutive patients undergoing diagnostic coronary angiography were recruited and randomized to the RRA (number [n]=700 or LRA (n=700 group. The primary end point was total procedural duration. Secondary end points included fluoroscopy time, dose of radiation including cumulative air kerma and dose area product, contrast volume, and the incidence of vascular complications. Results: Coronary procedural success was achieved in 682 of 700 (97.4% patients in the RRA and 680 of 700 (97.1% in the LRA. The total procedural time (RRA 14.1±6.3 minutes versus LRA 13.2±6.0 minutes; P=0.006 and fluoroscopy time (RRA 3.8±3.3 minutes versus LRA 3.4±2.8 minutes; P=0.046 were significantly shorter via LRA in comparison to RRA. The percentage of hydrophilic wire use was also lower in the LRA group (14% [RRA] versus 10% [LRA]; P=0.016. The dose of radiation and contrast volume were not different between the two approaches. No cases of major bleeding and vascular complications requiring surgical intervention were reported, other than with one patient who experienced a symptomatic stroke and died in the RRA group compared with none in the LRA group. Conclusion: The LRA seems to be a feasible alternative for coronary angiography in Asian patients due to shorter procedural duration and fluoroscopy time, as well as less hydrophilic wire use in comparison to RRA

  5. EFFICACY OF TRANEXAMIC ACID IN DECREASING BLOOD LOSS DURING AND AFTER CAESAREAN SECTION: A RANDOMIZED CASE CONTROL PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Tullika

    2014-03-01

    Full Text Available : INTRODUCTION: To reduce maternal mortality and morbidity caused by bleeding, it is important to reduce the amount of bleeding during and after lower segment caesarean section (LSCS. Tranexamic acid helps to reduce bleeding during and after LSCS. OBJECTIVES: To study the efficacy and safety of Tranexamic acid in reducing blood loss during and after Lower segment Caesarean Section (LSCS. METHODS: A randomized case controlled prospective study was conducted on 200 women undergoing lower segment cesarean section. Hundreds of them that were given tranexamic acid immediately before LSCS were compared to hundred others to whom tranexamic acid was not given. Blood loss was collected and measured during the two periods, from plancental delivery to end of LSCS and second from end of LSCS to two hours postpartum. RESULTS: Tranexamic acid significantly reduced the quantity of blood loss from placental delivery to end of LSCS, 202.25ml in the study group vs392.20 ml in the control group (p<0.001; from the end of LSCS, to 2 hours postpartum 3.80ml in the study group versus 112.25ml in the control group (p<0.001; In totality, it significantly reduced the quantity of blood loss from placental delivery to two hours postpartum i.e. 27.05ml in the study group versus 510.45ml in the control group (p < 0.001. No complications or side effects were noted. CONCLUSION: Tranexamic acid significantly reduced the amount of blood loss during and after LSCS. Tranexamic acid can be used prophylactically; moreover it is safer and effective in women undergoing LSCS.

  6. A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa.

    Science.gov (United States)

    Yildiz, Hamza; Senol, Levent; Ercan, Erdinc; Bilgili, Memet Ersan; Karabudak Abuaf, Ozlem

    2016-02-01

    Hyperbaric oxygen therapy (HBOT) appears to enhance wound healing, increase bactericidal activity, and act synergistically with a number of antibiotics. The aim of this study was to evaluate the efficacy of HBOT as an adjunctive therapy in patients with hidradenitis suppurativa (HS) treated with a combination of systemic rifampicin and clindamycin. The study was a prospective, single-center, single-dose, open-label, randomized controlled clinical study of HBOT in patients with moderate to severe HS. Efficacy was measured by modified Sartorius score (SS), HS Severity Index (HSSI), Dermatology Life Quality Index (DLQI), and a visual analog scale (VAS) before treatment and after the completion of 4 and 10 weeks of treatment. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were also measured. Forty-three patients were enrolled in the study. More patients in the HBOT than in the control group showed a decrease of ≥50% from baseline parameters at week 10 for SS (100%), HSSI (100%), DLQI (95.5%), VAS (100%), ESR (100%), and CRP (72.7%). Clinically and statistically significant improvements from baseline were observed at 4 and 10 weeks in HSSI (P = 0.009 at both), SS (P = 0.021 at both), and DLQI (P = 0.044 at week 4, P = 0.009 at week 10). Adjunctive HBOT was considered to be effective in significantly improving antibiotic treatment of HS. The treatment was well tolerated, and no unexpected safety issues were identified. PMID:26267600

  7. Mini-flared Kelman tip, reverse tip, and sidewinder tip with torsional phaco: a prospective randomized comparative study

    Directory of Open Access Journals (Sweden)

    Wilson Takashi Hida

    2015-02-01

    Full Text Available Purpose: To compare the efficiency of surgical procedures using three phaco tip designs in torsional phacoemulsification using the bevel-down technique. Methods: In this prospective, comparative, masked study, patients were randomly assigned to have torsional coaxial microincision cataract surgery using the mini-flared 45-degree Kelman tip, reversed mini-flared 30-degree Kelman tip, or Sidewinder 30-degree Kelman tip. Clinical measurements included preoperative and 3-month postoperative corrected distance visual acuity (CDVA, endothelial cell counts (ECC, and preoperative and 1-day postoperative central corneal thickness (CCT. Intraoperative measurements included phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE, and balanced salt solution volume (BSS. Results: The study evaluated 150 eyes of 150 patients. Intraoperatively, there was no statistically significant difference in cumulative dissipated energy, case time, torsional time, and aspiration time between the three tip configurations. However, less phaco time was used with the mini-flared 45-degree Kelman tip (p=0.02 than that with the Sidewinder 30-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. The mini-flared 45-degree Kelman tip and the reversed mini-flared 30-degree Kelman tip required significantly less balanced salt solution volume than that required by the Sidewinder 30-degree Kelman tip (p=0.009. There was no statistically significant difference in corrected distance visual acuity and endothelial cell counts between tips 3 months postoperatively (p>0.05. Conclusion: All three tips were effective with no intraoperative complications. When using torsional phacoemulsification through microincisions and the prefracture technique with the bevel-down technique, the mini-flared 45-degree Kelman tip required a lower mean phaco time than the reversed mini-flared 30-degree Kelman tip and the Sidewinder 30-degree Kelman tip.

  8. Shoulder Magnetic Resonance Arthrography: A Prospective Randomized Study of Anterior and Posterior Ultrasonography-Guided Contrast Injections

    Energy Technology Data Exchange (ETDEWEB)

    Koivikko, M.P.; Mustonen, A.O.T. (Dept. of Radiology, Helsinki Univ. Central Hospital, Helsinki (Finland))

    2008-10-15

    Background: Magnetic resonance (MR) arthrography is an accurate imaging method for internal shoulder derangements and rotator cuff pathologies. Both anterior and posterior contrast injection techniques, under palpatory, fluoroscopic, or ultrasonographic guidance have been described in the literature. However, clinical comparisons of the injection techniques remain few. Purpose: To compare the performance of anterior and posterior ultrasonography (US)-guided arthrography injections of the shoulder regarding patient discomfort and influence on diagnostic MR reading, and to illustrate the typical artifacts resulting from contrast leakage in the respective techniques. Material and Methods: 43 MR arthrographies were prospectively randomized into anterior and posterior US-guided contrast injections and performed by two radiologists, with the study of artifacts from contrast leakage. Pain from the injections was assessed by a survey utilizing a 100-mm visual analogue scale (VAS). Results: Of the 23 anterior injections, nine caused contrast artifacts in the subscapular tendon, and in three the leakage extended further anteriorly. Of the 20 posterior injections, 12 showed injection artifacts of the rotator cuff, extending outside the cuff in seven. Two of the anterior and none of the posterior artifacts compromised diagnostic quality. In posterior injections, the leakage regularly occurred at the caudal edge of the infraspinatus muscle and was easily distinguishable from rotator cuff tears. All patients completed the pain survey. Mean VAS scores were 25.0 (median 18, SD 22) for anterior, and 25.4 (median 16, SD 25) for posterior injections. The two radiologists achieved different mean VAS scores but closely agreed as to anterior and posterior VAS scores. Conclusion: Arthrography injections were fairly simple to perform under US guidance. Patient discomfort for anterior and posterior injections was equally minor. A tailored approach utilizing anterior or posterior injections

  9. Effect of chlorhexidine varnish on gingival growth in orthodontic patients: a randomized prospective split-mouth study

    Directory of Open Access Journals (Sweden)

    Henrique Pretti

    2015-10-01

    Full Text Available Introduction: Fixed orthodontic appliances patients suffer limitations on the effective control of biofilm by mechanical methods, bringing the need of a coadjutant in the control of inflammation and oral health improvement.Objective: The aim of this prospective split-mouth blind study was to analyze the effect of a 40% chlorhexidine (CHX varnish on gingival growth of patients with orthodontic fixed appliances. Methods: Healthy teenage patients with fixed orthodontic appliances and increased gingival volume were recruited (n = 30. Each individual was his own control, having in the maxilla one control side and one treatment side. An application of varnishes occurred on the vestibular area of the upper premolars and first molar crowns, on the control side (placebo varnish and on the experimental side (EC40(r Biodentic CHX varnish. The varnishes and sides were randomly chosen and its identification and group was kept by a third party observer and it was not revealed to the researchers and participants until the end of study. In order to establish a baseline registration, digital photographs were taken by a trained photographer before varnish application at baseline (T0, as well as 14 days (T14 and 56 days (T56 after the application. The gingival volume was calculated indirectly using the vestibular areas (mm2 of the upper second premolars' clinical crowns by RapidSketch(r software, at all study times. The data were analyzed using ANOVA and the Turkey-Krammer test.Results:It was observed, in the final sample of 30 individuals, that at T0, the control and treatment groups were similar. At T14 and T56, a progressive reduction of the clinical crown area was seen in the control group, and an increase in the average area was detected in the experimental group (p < 0,05.Conclusions: The use of 40% CHX varnish decreases the gingival overgrowth in patients undergoing orthodontic treatment. Further studies are necessary to set the action time and frequency of

  10. A PROSPECTIVE RANDOMIZED STUDY ON THE CLINICO - ELECTROPHYSIOLOGICAL RESULTS OF OPEN AND ENDOSCOPIC CARPAL TUNNEL RELEASE SURGERIES

    Directory of Open Access Journals (Sweden)

    Sreejith

    2015-09-01

    Full Text Available OBJECTIVE: To compare short term surgical outcome of carpal tunnel syndrome release, against endoscopic approach. MATERIALS AND METHODS: A prospective randomized study was conducted on 91 patients with carpal tunnel syndrome, who were treated endoscopically or surgically from 2011 to 2013 at KMCT medical college, Calicut . All the patients were confirmed as a case of carpal tunnel syndrome after correlating sensory nerve conduction studies with clinical findings. None of these cases responded to medical treatment and hence opted surgery. Out of these 91 cases, 71 patients were available for post - surgical follow up. On 35 cases endoscopic CTR was performed and remaining 36 were open CTR. These patients were followed up for 6 months and each patient was evaluated for symptom amelioration, complications, operation time, time needed to resume normal lifestyle and the frequency of revision surgery if needed. RESULTS: First few months after surgery, it was observed that endoscopically treated patients were better symptomatically and functionally. Wound scarring, scar tenderness and other local wound problems were significantly more pronounced in patients who underwent open CTR. R eturn to normal daily activities were more delayed in open CTR patients compared to endoscopically treated wrists. Even then there was no significant symptom amelioration, electromyographic testing and complications at the end of six months between these two methods. CONCLUSION: Immediate, short term results were better in endoscopically treated patients due to cosmetic advantages as there is less scar and early return to activities of daily living. On a 6 month review, it was found that both the methods gave comparable results.

  11. Shoulder Magnetic Resonance Arthrography: A Prospective Randomized Study of Anterior and Posterior Ultrasonography-Guided Contrast Injections

    International Nuclear Information System (INIS)

    Background: Magnetic resonance (MR) arthrography is an accurate imaging method for internal shoulder derangements and rotator cuff pathologies. Both anterior and posterior contrast injection techniques, under palpatory, fluoroscopic, or ultrasonographic guidance have been described in the literature. However, clinical comparisons of the injection techniques remain few. Purpose: To compare the performance of anterior and posterior ultrasonography (US)-guided arthrography injections of the shoulder regarding patient discomfort and influence on diagnostic MR reading, and to illustrate the typical artifacts resulting from contrast leakage in the respective techniques. Material and Methods: 43 MR arthrographies were prospectively randomized into anterior and posterior US-guided contrast injections and performed by two radiologists, with the study of artifacts from contrast leakage. Pain from the injections was assessed by a survey utilizing a 100-mm visual analogue scale (VAS). Results: Of the 23 anterior injections, nine caused contrast artifacts in the subscapular tendon, and in three the leakage extended further anteriorly. Of the 20 posterior injections, 12 showed injection artifacts of the rotator cuff, extending outside the cuff in seven. Two of the anterior and none of the posterior artifacts compromised diagnostic quality. In posterior injections, the leakage regularly occurred at the caudal edge of the infraspinatus muscle and was easily distinguishable from rotator cuff tears. All patients completed the pain survey. Mean VAS scores were 25.0 (median 18, SD 22) for anterior, and 25.4 (median 16, SD 25) for posterior injections. The two radiologists achieved different mean VAS scores but closely agreed as to anterior and posterior VAS scores. Conclusion: Arthrography injections were fairly simple to perform under US guidance. Patient discomfort for anterior and posterior injections was equally minor. A tailored approach utilizing anterior or posterior injections

  12. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    Directory of Open Access Journals (Sweden)

    Stefan Landgraeber

    2013-07-01

    Full Text Available There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS or a conventional lateral approach (CON. We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36 or CON (n=39 approach. The Western Ontario\tand\tMcMaster\tUniversities Osteoarthritis Index and Harris Hip score (HHS were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045. But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study.

  13. A double-blind, prospective, randomized, multicenter group comparison study of iopromide 240 vs iohexol 240 in myelography

    International Nuclear Information System (INIS)

    The aim of this study was to evaluate the safety and efficacy of iopromide 240 mgI/ml in comparison with iohexol 240 mgI/ml in myelography. A total of 421 patients in seven centers and four countries received an average of 11.9 ml of either iopromide 240 (278 patients) or iohexol 240 (143 patients) for X-ray and/or CT myelography in a randomized (2:1), prospective, double-blind study. All patients were followed up 3-4 h after the procedure, and 327 patients remained hospitalized for 24 h. In 82 patients an EEG was recorded prior to as well as 3-4 h and 24 h after myelography. Physical examinations, including measurement of vital signs, were performed in all patients at these time points. The results were subject to statistical analysis with the primary variable being the incidence of adverse events. Both contrast media (CM) were equally effective in terms of opacification. The rating for opacity was ''good'' or ''excellent'' in 88 % for both CM. Four patients (iopromide group: n = 3; iohexol group: n = 1) had transient EEG changes but did not show clinical symptomatology. The overall rate of patients experiencing any adverse event (AE) was 16.9 % for iopromide 240 and 14.0 % for iohexol 240. Equivalence testing was inconclusive; however, the results indicated equivalence. The rate for AEs considered as study-drug related was slightly lower with iopromide 240 than with iohexol 240 (7.2 vs 7.7 %, respectively). Neither unknown nor unexpected AEs known for myelographic X-ray CM nor serious adverse events were observed. Iopromide 240 and iohexol 240 are equally safe and effective and can be recommended for myelography. (orig.)

  14. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol--EASE

    DEFF Research Database (Denmark)

    Grunberg, Steven; Chua, Daniel; Maru, Anish;

    2011-01-01

    Addition of aprepitant, a neurokinin-1 receptor antagonist (NK1RA), to an ondansetron and dexamethasone regimen improves prevention of chemotherapy-induced nausea/vomiting (CINV), particularly during the delayed phase (DP; 25 to 120 hours). Therefore, recommended antiemetic regimens include multi...

  15. Quality of life of advanced ovarian cancer patients in the randomized phase III study comparing primary debulking surgery versus neo-adjuvant chemotherapy

    NARCIS (Netherlands)

    Greimel, E.; Kristensen, G.B.; Burg, M.E.L. van der; Coronado, P.; Rustin, G.; Rio, A.S. del; Reed, N.S.; Nordal, R.R.; Coens, C.; Vergote, I.; Massuger, L.F.A.G.; Ottevanger, P.B.

    2013-01-01

    OBJECTIVE: The EORTC 55971 trial compared primary debulking surgery (PDS) versus neo-adjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The impact of both treatment arms on quality of life (QOL) is reported. METHODS: Patients with stages IIIc or IV ovarian cancer completed th

  16. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    International Nuclear Information System (INIS)

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.)

  17. Alterations of nutritional status: impact of chemotherapy and radiation therapy

    International Nuclear Information System (INIS)

    The nutritional status of a cancer patient may be affected by the tumor, the chemotherapy and/or radiation therapy directed against the tumor, and by complications associated with that therapy. Chemotherpay-radiotherapy is not confined exclusively to malignant cell populations; thus, normal tissues may also be affected by the therapy and may contribute to specific nutritional problems. Impaired nutrition due to anorexia, mucositis, nausea, vomiting, and diarrhea may be dependent upon the specific chemotherapeutic agent, dose, or schedule utilized. Similar side effects from radiation therapy depend upon the dose, fractionation, and volume irradiated. When combined modality treatment is given the nutritional consequences may be magnified. Prospective, randomized clinical trials are underway to investigate the efficacy of nutritional support during chemotherapy-radiotherapy on tolerance to treatment, complications from treatment, and response rates to treatment. Preliminary results demonstrate that the administration of total parenteral nutrition is successful in maintaining weight during radiation therapy and chemotherapy, but that weight loss occurs after discontinuation of nutritional support. Thus, longterm evaluation is mandatory to learn the impact of nutritional support on survival, diease-free survival, and complication rates, as well as on the possible prevention of morbidity associated with aggressive chemotherapy-radiation therapy

  18. Locoregionally advanced carcinoma of the oropharynx: conventional radiotherapy vs. accelerated hyperfractionated radiotherapy vs. concomitant radiotherapy and chemotherapy - a multicenter randomized trial

    International Nuclear Information System (INIS)

    Purpose: To compare conventional fractionation radiation therapy (RT), Arm A, vs. split-course accelerated hyperfractionated RT (S-AHF), Arm B, vs. conventional fractionation RT plus concomitant chemotherapy (CT), Arm C, in terms of survival and toxicity for advanced, unresectable epidermoid tumors of oropharynx. Methods and Materials: Between January 1993 and June 1998, 192 previously untreated patients affected with Stage III and IV oropharyngeal carcinoma (excluding T1N1 and T2N1) were accrued in a multicenter, randomized Phase III trial (ORO 93-01). For Arms A and C, 66-70 Gy in 33-35 fractions, 5 days a week, were administered in 6.5-7 weeks to tumor and positive nodes. In Arm B, the dose delivered to tumor and involved nodes was 64-67.2 Gy, giving 2 fractions of 1.6 Gy every day with an interfraction interval of at least 4 h and preferably 6 h, 5 days a week. At 38.4 Gy, a 2-week split was planned; after the split, RT was resumed with the same modality. In Arm C, CT regimen consisted of carboplatin and 5-fluorouracil (CBDCA 75 mg/m2, Days 1-4; 5-FU 1,000 mg/m2 i.v. over 96 h, Days 1-4, recycling every 28 days (at 1st, 5th, and 9th week). Results: No statistically significant difference was detected in overall survival (p=0.129): 40% Arm A vs. 37% Arm B vs. 51% Arm C were alive at 24 months. Similarly, there was no statistically significant difference in terms of event-free survival (p=0.196): 20% for Arm A, 19% for Arm B, and 37% for Arm C were event free at 24 months. On the contrary, the 2-year disease-free survival was significantly different among the three arms (p = 0.022), with a superiority for Arm C. At 24 months, the proportion of patients without relapse was 42% for Arm C vs. 23% for Arm A and 20% for Arm B. Patients in Arm A less frequently developed G3+ acute mucositis than their counterparts in Arm B or C (14.7% vs. 40.3% vs. 44%). Regarding the CT-related acute toxicity, apart from 1 case of fatal nephrotoxicity, only hematologic G3+ (Grade 3 or

  19. Is it relevant that intra-arterial chemotherapy may be effective for advanced pancreatic cancer?

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Unresectable pancreatic cancers have an extremely dismal prognosis and chemoresistant nature. The treatment of pancreatic cancer is still problematic.Gemcitabine is a promising new agent that has been studied recently for palliation of advanced pancreatic cancer. However, the response rates have been highly variable, and are often irreproducible. To improve this low response rate, various treatments are needed because no standard treatment exists. Intra-arterial chemotherapy is considered to take advantage of the first pass effect of the drug, generating higher local drug concentrations in tumor cells with lower toxicity.Regional intra-arterial chemotherapy may provide high levels of cytostatic concentrations within the tumor and, simultaneously, a low rate of systemic side effects compared with systemic administration of anti-neoplastic drugs. Intra-arterial chemotherapy has been introduced as an alternative treatment for advanced pancreatic cancer. Further clinical trials of this method should be subjected to a prospective randomized controlled study for advanced pancreatic cancer.

  20. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    International Nuclear Information System (INIS)

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9± 11.2 in group M, 46.5±9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly

  1. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)

    2001-06-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9{+-} 11.2 in group M, 46.5{+-}9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of

  2. Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Lo Lun-Chien

    2012-12-01

    Full Text Available Abstract Background Cancer is one of the major health issues worldwide. An increasing number of cancer patients are offered treatment with surgery, chemotherapy and radiotherapy. Traditional Chinese medicine (TCM is one of the most common complementary therapies offered to cancer patients in Taiwan. We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of TCM in patients with cancer. Methods/design In this study, inclusion criteria are postoperative patients with histologically confirmed cancer within 3 years who are undergoing chemotherapy or radiotherapy, more than 18 years old, have given signed informed consent, have the ability to read Chinese, and the ability for oral intake. Exclusion criteria include being pregnant, breast feeding, having completed chemotherapy or radiotherapy, brain metastasis with Eastern Cooperative Oncology Group (ECOG performance status of two to four, delusion or hallucinations, acute infection, and have received medications under other clinical trials. The patients were separated into an intervention group (Shen-Mai-San, SMS and a placebo group for four weeks using a randomized, double-blind procedure. The European Organization for Research and Treatment of Cancer (EORTC Quality of Life questionnaire (QOL-C30 was used to evaluate the quality of life. General data, hemoglobin (Hb, hematocrit (Hct, glutamic-oxalacetic transaminase (GOT, glutamic-pyruvic transaminase (GPT, blood urea nitrogen (BUN, creatinine, carcinoembryonic antigen (CEA, TCM diagnosis data and heart rate variability (HRV were also recorded. These data were collected at baseline, two weeks and four weeks after receiving medication. The patients were prescribed granules which contained therapeutic medicines or placebo. Paired-T test was used for statistical analysis. Discussion Shen-Mai-San is composed of processed Ginseng radis, Liriope spicata, and Schizandrae fructus. It was found to be effective for

  3. Postoperative irradiation in epithelial ovarian cancer. Is chemotherapy an adequate replacement for percutaneous radiotherapy?

    International Nuclear Information System (INIS)

    As a result of the low incidence of ovarian carcinoma diagnosed in early stages, only a few randomized clinical trials have been performed of both systemic chemotherapy and external beam radiotherapy in intermediate/high risk patients. Thus we collected data based on a review of the literature with special regard to criteria recommended to select patients for postoperative abdominopelvic radiotherapy and chemotherapy respectively. Despite high response rates and high negative second-look operation findings to chemotherapy, the rates for cures and long-term survival have not been improved significantly and have also failed to show a significant advantage compared with results achieved by the use of external beam radiotherapeutic modalities. Long-term survival rates of the relative small number of ovarian carcinoma patients in the early stages treated in prospective randomized trials comparing both treatment modalities do not justify the assumed superiority of chemotherapy over radiotherapy. Abdominopelvic irradiation following staging laparotomy is not recommended for advanced stages and has at the most limited benefit as consolidation therapy after successfully cytoreductive chemotherapy depending on the amount of residual tumor. (orig./MG)

  4. Should all patients with serous and clear cell endometrial carcinoma receive adjuvant chemotherapy?

    Science.gov (United States)

    Boren, Todd P; Miller, David S

    2010-11-01

    Uterine papillary serous carcinoma (UPSC) and uterine clear cell carcinoma (UCCC) represent two rare subtypes that have an increased risk of recurrence and worse overall survival compared with the more common endometrioid endometrial cancers. Meaningful data in the form of prospective randomized trials is lacking for both advanced and early-stage UPSC and UCCC. Data extrapolated from prospective trials in advanced endometrioid endometrial cancer and retrospective trials on early-stage UPSC suggest that adjuvant platinum and taxane-based chemotherapy may provide a survival benefit for these patients. Future trials specifically examining UPSC and UCCC are needed to elucidate the optimal treatment regimen for these patients. Given the current data, the option of chemotherapy should be considered in treatment-planning discussions for all patients with UPSC and UCCC. PMID:21118038

  5. The effect of low-dose acetylsalicylic acid on bleeding after transurethral prostatectomy--a prospective, randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Nielsen, Jesper Dan; Holm-Nielsen, A; Jespersen, J;

    2000-01-01

    OBJECTIVE: An increase in the loss of blood after ingestion of acetylsalicylic acid (ASA) has been reported after several types of surgery, but randomized placebo-controlled studies have exclusively been performed after coronary artery bypass surgery. The reported effects of ASA on bleeding after...... transurethral prostatectomy (TURP) have been conflicting. We have studied the effect of low doses of ASA (150 mg) on bleeding after TURP in a prospective, randomized, double-blind, placebo-controlled trial. PATIENTS AND METHODS: Patients were randomized to receive either 150 mg ASA (n = 26) or placebo (n = 27...... group (median 284; quartiles 196-660 ml) was significantly higher than in the placebo group (median 144; quartiles 75-379 ml), (p = 0.011). No significant difference was observed between the groups regarding the amount of resected tissue (p = 0.209) or the operating time (p = 0.297). In both groups the...

  6. Chemotherapy (For Parents)

    Science.gov (United States)

    ... Story" 5 Things to Know About Zika & Pregnancy Chemotherapy KidsHealth > For Parents > Chemotherapy Print A A A ... have many questions and concerns about it. About Chemotherapy Chemotherapy (often just called "chemo") refers to medications ...

  7. Immunomodulatory role of Tinospora cordifolia as an adjuvant in surgical treatment of diabetic foot ulcers: A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Purandare Harshad

    2007-06-01

    Full Text Available Background : Chronic diabetic patients with wounds have deficient growth factors and impaired local and systemic cellular immunity. Treatment with growth factors is expensive with risk of infection transmission, and these factors may not achieve optimum wound concentration. We evaluated the role of generalized immunomodulation in diabetic ulcers by using Tinospora cordifolia as an adjuvant therapy and studied its influence on parameters/determinants of healing, on bacterial eradication and on polymorphonuclear phagocytosis. Materials and Methods :A prospective double-blind randomized controlled study lasting for over 18 months in 50 patients. The ulcer was classified by wound morphology and severity with Wound Severity Score (Pecoraro-Reiber system. Mean ulcer area, depth and perimeter were measured and swabs taken for culture. Blood was collected to assess polymorphonuclear % phagocytosis (PMN function by Lehrer-Cline C. albicans method. Medical therapy, glycemic control, debridement, wound care were optimized. At 4 weeks, parameters were reassessed. PMN function was reviewed at 3 months. Results and Analysis : Forty-five patients completed the trial: study group - 23 (M:F = 17:1; mean age = 56.3 years; mean ulcer duration = 21.1 days; control group 22 (M:F = 19:3; mean age = 56.3 years; mean ulcer duration = 30.4 days. Net improvement was seen in 17 patients (73.9% in the study group; while in the control group, in 13 patients (59.1%; P = 0.292. Specific parameters included rate of change of ulcer area - cm 2 /day (study - 0.15; control - 0.07; P = 0.145; rate of change of ulcer perimeter - mm/day (study - 0.09; control = - 0.07; P = 0.089; change of depth - mm (study - 2.2; control - 1.4; P = 0.096; change of wound score (study - 14.4; control - 10.6; P = 0.149; total number of debridements (study - 1.9; control - 2.5; P = 0.03 and change in % phagocytosis (study - 3.9; control - 2.3; P = 0.048. Conclusion : Diabetic patients with foot ulcers

  8. [Results of ventral hernia repair: comparison of suture repair with mesh implantation (onlay vs sublay) using open and laparoscopic approach--prospective, randomized, multicenter study].

    Science.gov (United States)

    Wéber, György; Horváth, Ors Péter

    2002-10-01

    Incisional hernias is a frequent complication following abdominal surgery, it develops in 11-20% of patients who had laparotomies. Different operative techniques are used for repair but results are often poor. In the absence of valid scientific data, there is no general agreement on the best surgical treatment. To provide evidence based surgery a nation-wide multi-center, prospective, randomized study is set up. The present study compares suture and mesh repairs in different positions, using open and laparoscopic approach to define standard indication for the treatment of incisional hernias. The study was started in March, 2002, with 23 surgical departments participating. Each report about 100 patients with incisional hernia repair. The 2300 consecutive patients (who are 18 to 70 years old) with primary incisional hernia or first recurrent umbilical hernia are randomized. Patients are divided in two groups. If the hernia is between 5-25 cm2 (Group I) they are selected at random either for prosthetic (sublay) or suture repair. In patients with a hernia larger than 25 cm2 (Group II) mesh is implanted at random as either sublay or onlay position using a computer randomization program. After a short learning period, in Group II the laparoscopic approach will also be randomized. Postoperative outcome, complications and recurrence are recorded. The study will run for five years. All collected data are sent to the coordinating center via internet to be entered into database. PMID:12474512

  9. 1,500 IU human chorionic gonadotropin administered at oocyte retrieval rescues the luteal phase when gonadotropin-releasing hormone agonist is used for ovulation induction: a prospective, randomized, controlled study

    DEFF Research Database (Denmark)

    Al Humaidan, Peter Samir Heskjær; Ejdrup Bredkjaer, Helle; Westergaard, Lars Grabow;

    2010-01-01

    OBJECTIVE: To prospectively assess the reproductive outcome with a small bolus of hCG administered on the day of oocyte retrieval after ovulation induction with a GnRH agonist (GnRHa). DESIGN: Prospective, randomized trial. SETTING: Three hospital-based IVF clinics. PATIENT(S): Three hundred five...

  10. Comparison of the effects of remifentanil andalfentanil on cardiovascular response to nasotracheal intubation: A prospective, randomized, double-blind study

    Science.gov (United States)

    Olmez, Gonul; Ali Ozyilmaz, Mehmet; Menekse, Ali

    2005-01-01

    Background: Nasotracheal intubation is often necessary in patients undergoingelective or emergency maxillofacial surgery. Previous studies have suggested that the increase in blood pressure after nasotracheal intubation is significantly greater than the increase after orotracheal intubation. Many drugs, including narcotic analgesics, are effective in modifying cardiovascular responses to orotracheal intubation. Objective: The effects of remifentanil and alfentanil on the cardiovascularresponses to nasotracheal intubation were compared in healthy patients scheduled to undergo surgery. Methods: This prospective, randomized, double-blind study was conductedat the Department of Anesthesiology and Reanimation, Faculty of Medicine, Dicle University, Diyarbakir, Turkey. Patients aged 16 to 65 years scheduled to undergo elective maxillofacial surgery and who were American Society of Anesthesiologists status I or 11 were randomly assigned to receive remifentanil 1 μg/kg in 10 mL saline over 30 seconds followed by an infusion of 0.5 μg/kg · min, or alfentanil 10 μg/kg in 10 mL saline over 30 seconds followed by an infusion of saline. Anesthesia was then induced with propofol, cisatracurium, and 1% isoflurane with 66% nitrous oxide in oxygen. Heart rate (HR) and systolic and diastolic arterial pressures (SAP and DAP, respectively) were measured noninvasively at 2 minutes before general anesthesia induction (baseline); 2 minutes after induction; and 1, 3, and 5 minutes after nasotracheal intubation. Patients were monitored for cardiac changes using electrocardiography. Results: Forty consecutive patients were enrolled in the study. Twenty patients (11 males, 9 females; mean [SD] age, 27.7 [12.6] years) received remifentanil, and 20 patients (12 males, 8 females; mean [SD] age, 31.5 [17.2] years) received alfentanil. Two minutes after anesthesia induction, mean (SD) arterial pressures decreased significantly from baseline in the remifentanil group (changes, 22 [8]/11 [6] mm

  11. PROSPECTIVE RANDOMIZED DOUBLE BLINDED PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF INTRAVENOUS DEXMEDETOMIDINE ON SPINAL BUPIVACAINE ANAESTHESIA

    Directory of Open Access Journals (Sweden)

    Janaki Babu

    2016-02-01

    Full Text Available BACKGROUND AND AIMS There is a dearth of studies on the effect of intravenously administered Dexmedetomidine in Sub Arachnoid Block hence, this study was conducted to compare the effects of intravenously administered Dexmedetomidine prior to the administration of subarachnoid block with bupivacaine 0.5% heavy, on hemodynamic variables and the level and onset and duration of sensory and motor blockade. MATERIAL AND METHODS After obtaining ethical Committee approval, a double-blind, randomized prospective clinical study was conducted on 90 American Society of Anesthesiologist Grade I and II patients in the age group of 18-55 years, divided randomly into two groups: Group D received 50 ml solution containing Inj. Dexmedetomidine infusion at 0.5 mcg/kg for 10 minutes, and Group P received 50 ml of solution 0.9% Normal Saline as infusion at 10 minutes time. Subsequently Spinal Anaesthesia is carried out with Bupivacaine heavy 0.5%, and carried out recordings as per protocol. Besides Hemodynamic parameters other parameters observed were effectiveness, Sedation score; highest level of sensory block achieved; Motor and Sensory block; Time for first rescue analgesic requirement were recorded. RESULTS Group D (n=45 (Mean±SD Sedation Score 3.42±0.621 and Group P (n=45 (Mean±SD Sedation Score 1.80±0.405. Better sedation was seen in Group – D with a p value of less than 0.0001.The highest level of sensory blockade achieved was significantly higher in Group D when compared to the control group, and mean duration (in minutes to achieve the highest sensory blockade in both the groups: Group D (n=45 (Mean±SD 7.91±2.42 and Group P (n=45 (Mean±SD 9.82±3.973 p Value< 0.0001. The highest level of sensory blockade achieved was significantly higher in Group D when compared to the control group, and mean duration (in minutes to achieve the highest sensory blockade in both the groups. Group D (n=45 (Mean±SD 7.91±2.42 and Group P(n=45 (Mean±SD 9.82±3.973 p

  12. Prospective evaluation of fluoro-2-deoxyglucose imaging for post-chemotherapy residual masses in patients with germ cell tumours: diagnostic performance and clinical impact

    International Nuclear Information System (INIS)

    Purpose: To establish the predictive value of [18F]-FDG coincidence detection emission tomography (CDET) for detecting viable cancer in residual post-chemotherapy masses in germ cell tumour (GCT) patients and to determine its influence on subsequent patient management. Patients and methods: 30 CDET examinations were performed in 15 patients with a Seminoma and in 12 patients with a non seminomatous GCT (NSGCT) and post-chemotherapy residual masses > 1 cm with negative tumour markers serum levels. Results were correlated with either the histology of the resected lesion or the clinical follow-up (median follow-up = 27). Before FDG imaging, the referring physician was asked what was the scheduled therapeutic modality for the patient. This was later compared to the management actually applied in the light of the FDG imaging information. Results: In seminoma patients, 10 FDG CDET were true negative (TN), 3 false negative (EN) and 5 true positive (TP) and in NSGCT patients, 7 were TN, one FN, 3 TP and one false positive, thus leading to an overall accuracy of 83%. FDG imaging induced changes in the management of 52% of patients (15/29), and 87% (13/15) of these changes were appropriate, considering the subsequent clinical course of disease. Conclusion: [18F]-FDG imaging may help to limit indications for resection of residual masses in patients with seminoma and to suspect treatment failure, thus allowing faster initiation of salvage treatment in both seminoma and NSGCT patients. However, patients with a negative CDET examination should still be carefully followed-up, since FN results cannot be ruled out, especially in poor prognosis patients. (author)

  13. Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy to Treat Advanced/Recurrent Epithelial Ovarian Cancer: Results from a Retrospective Study on Prospectively Established Database

    Directory of Open Access Journals (Sweden)

    Jian-Hua Sun

    2016-04-01

    Full Text Available BACKGROUND: Despite the best standard treatment, optimal cytoreductive surgery (CRS and platinum/taxane-based chemotherapy, prognosis of advanced epithelial ovarian carcinoma (EOC remains poor. Recently, CRS plus hyperthermic intraperitoneal chemotherapy (HIPEC has been developed to treat peritoneal carcinomatosis (PC. This study was to evaluate the efficacy and safety of CRS+HIPEC to treat PC from advanced/recurrent EOC. METHODS: Forty-six PC patients from advanced EOC (group A or recurrent EOC (group B were treated by 50 CRS+HIPEC procedures. The primary endpoints were progression-free survival (PFS and overall survival (OS; the secondary endpoints were safety profiles. RESULTS: The median OS was 74.0 months [95% confidence interval (CI 8.5-139.5] for group A versus 57.5 months (95% CI 29.8-85.2 for group B (P = .68. The median PFS was not reached for group A versus 8.5 months (95% CI 0-17.5 for group B (P = .034. Better median OS correlated with peritoneal cancer index (PCI 20 group, P = .01, complete cyroreduction (residual disease ≤ 2.5 mm [79.5 months for completeness of cytoreduction (CC score 0-1 vs 24.3 months for CC 2-3, P = .00], and sensitivity to platinum (65.3 months for platinum-sensitive group vs 20.0 for platinum-resistant group, P = .05. Serious adverse events occurred in five patients (10.0%. Multivariate analysis identified CC score as the only independent factor for better survival. CONCLUSION: For advanced/recurrent EOC, CRS+HIPEC could improve OS with acceptable safety.

  14. Sentinel lymph node biopsy using dye alone method is reliable and accurate even after neo-adjuvant chemotherapy in locally advanced breast cancer - a prospective study

    Directory of Open Access Journals (Sweden)

    Mishra Ashwani

    2011-02-01

    Full Text Available Abstract Background Sentinel lymph node biopsy (SLNB is now considered a standard of care in early breast cancers with N0 axillae; however, its role in locally advanced breast cancer (LABC after neo-adjuvant chemotherapy (NACT is still being debated. The present study assessed the feasibility, efficacy and accuracy of sentinel lymph node biopsy (SLNB using "dye alone" (methylene blue method in patients with LABC following NACT. Materials and methods Thirty, biopsy proven cases of LABC that had received three cycles of neo-adjuvant chemotherapy (cyclophosphamide, adriamycin, 5-fluorouracil were subjected to SLNB (using methylene blue dye followed by complete axillary lymph node dissection (levels I-III. The sentinel node(s was/were and the axilla were individually assessed histologically. The SLN accuracy parameters were calculated employing standard definitions. The SLN identification rate in the present study was 100%. The sensitivity of SLNB was 86.6% while the accuracy was 93.3%, which were comparable with other studies done using dual lymphatic mapping method. The SLN was found at level I in all cases and no untoward reaction to methylene blue dye was observed. Conclusions This study confirms that SLNB using methylene blue dye as a sole mapping agent is reasonably safe and almost as accurate as dual agent mapping method. It is likely that in the near future, SLNB may become the standard of care and provide a less morbid alternative to routine axillary lymph node dissection even in patients with LABC that have received NACT.

  15. A prospective dosimetric and clinical comparison of acute hematological toxicities in three-dimensional conformal radiation therapy and intensity modulated radiation therapy with concurrent chemotherapy in carcinoma cervix

    Directory of Open Access Journals (Sweden)

    H U Avinash

    2015-01-01

    Full Text Available Background and Objectives: Acute hematological toxicities are an important cause of morbidity in patients receiving concurrent chemoradiation to pelvis in carcinoma cervix. The objective of this study was to evaluate the role of intensity-modulated radiotherapy (IMRT in reducing the dose to the bone marrow as compared with three-dimensional conformal radiotherapy (3DCRT and hence its impact on reducing the acute hematological toxicities. Materials and Methods: Eleven consecutive patients treated with IMRT and 12 patients treated with 3DCRT to the whole pelvis along with concurrent chemotherapy were selected. Bone marrow was delineated. V10 Gy, V20 Gy, V95%, and Dmean of bone marrow were recorded. Weekly blood counts were recorded and graded as per Common Terminology Criteria version 4.0 for all the patients. Results: The dose to the bone marrow V20 Gy was 206.78 ± 57.10 cc (75% and 251.70 ± 40.45 cc (91% for IMRT and 3DCRT, respectively (P = 0.04 and V95% was 23.30 ± 8.34% and 46.76 ± 6.71% for IMRT and 3DCRT, respectively (P = 0.001. The grade of toxicities during each week did not show the difference in either arm. However, the total count and Neutrophil counts during the 2nd week showed statistical significance between IMRT and 3DCRT. Conclusion: IMRT significantly reduces the dose to the bone marrow as compared to 3DCRT. The reduction of the dose did not translate into a decrease in acute hematological toxicities. Concurrent platinum-based chemotherapy is the probable cause for the hematological toxicities.

  16. Prospective Randomized Comparison of Ovarian Blockade with Nafarelin Versus Leuprolide During Ovarian Stimulation with Recombinant FSH in an ICSI Program

    OpenAIRE

    Franco Jr, José G; Baruffi, Ricardo L. R.; Mauri, Ana L; Petersen, Claudia G; Chufallo, José E.; Felipe, Valéria; Garbellini, Erika

    2001-01-01

    Purpose: A prospective study was conducted to compare the efficiency of ovarian blockade with nafarelin versus leuprolide in a population whose indication for assisted reproduction was the male factor.

  17. Treating gastrointestinal cancer by intervention, intraperitoneal hyperthermic perfusion chemotherapy, intravenous micro-pump chemotherapy

    International Nuclear Information System (INIS)

    157 cases of gastrointestinal cancer patients after resection were randomly divided into treated group and control group. The treated group (intraperitoneal hyperthermic perfusion chemotherapy combined with postoperative continuous intraarterial infusion and intravenous micro-pump chemotherapy) consisted of 72 cases, the control group (Intravenous chemotherapy), 85 cases. The peritoneal and hepatic metastasis rates and 3 a survival rate were studied. The intraperitoneal hyperthermic perfusion chemotherapy combined with the postoperative continuous intraarterial infusion and intravenous micro-pump chemotherapy is an effective way to control the recurrence on the peritoneal and hepatic metastasis of advanced gastrointestinal neoplasms after operation. (authors)

  18. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    Energy Technology Data Exchange (ETDEWEB)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Brunner, Thomas B. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany); Witzigmann, Helmut [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Marti, Lukas [Hospital of Kanton St. Gallen, General Surgery, St. Gallen (Switzerland); Bechstein, Wolf-Otto [University Hospital Frankfurt, Department of Surgery, Frankfurt/Main (Germany); Bruns, Christiane [University Hospital Munich, Department of Surgery - Hospital Campus Grosshadern, Munich (Germany); University Hospital Magdeburg, Department of Surgery, Magdeburg (Germany); Jungnickel, Henry [Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Schreiber, Stefan [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Grabenbauer, Gerhard G. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Hospital Coburg, Department of Radiation Oncology, Coburg (Germany); Meyer, Thomas [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Hospital Ansbach, General Surgery, Ansbach (Germany); Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2014-09-25

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [German] Mehrere nichtrandomisierte Studien zeigten, dass eine neoadjuvante Therapie das Ueberleben bei Patienten mit Pankreaskarzinom verlaengert. Beim lokal fortgeschrittenen Rektumkarzinom gehoert die

  19. Prospective, randomized, controlled, and open study in primarily inoperable, stage III non-small cell lung cancer (NSCLC) patients given sequential radiochemotherapy with or without epoetin alfa

    International Nuclear Information System (INIS)

    Background and purpose: Induction chemotherapy is associated with anemia in non-small cell lung cancer (NSCLC) patients undergoing radiotherapy. This randomized, open-label study compared the effect of sequential radiochemotherapy (RCHT) versus RCHT + epoetin alfa (RCHT + EPO), with respect to 2-year overall survival (OS). Material and methods: Patients ⩾ 18 years received sequential RCHT; one arm also received EPO (chemotherapy day 1, when Hb < 12 g/dL). Kaplan–Meier analysis with log-rank test, and Cox-regression methods were performed. Results: Of the 385 patients randomized (RCHT + EPO: n = 195; RCHT: n = 190), 78 (RCTH + EPO: 46 [23.6%]; RCHT: 32 [16.8%]) were anemic at baseline. Two-year OS was higher in RCHT + EPO-treated versus RCHT-treated (28.5% [95% CI: 22.2–35.1%] versus 20.6% [95% CI: 15.1–26.8%] [p = 0.2278]), and requirement for RBC transfusion was lower (24/195 [12.3%] versus 61/190 [32.1%]). In anemic (baseline) patients (post hoc analysis), median survival was shorter in RCTH-treated (212 days) versus RCHT + EPO-treated (343 days) (Hazard ratio = 1.62 [95% CI: 0.99–2.63], p = 0.0525). Adverse events were documented in 72.7% (RCHT + EPO: 75.0%; RCHT: 70.5%) patients, and thrombovascular events (TVEs) in 45 patients (RCHT + EPO: 16.7%; RCHT: 7.9%; p = 0.0099). Conclusions: A statistically non-significant trend for 2-year OS was observed in a sub-group of EPO-treated NSCLC-patients with baseline anemia, although this trend was not maintained in the overall population with inoperable NSCLC

  20. Recombinant human granulocyte colony-stimulating factor (filgrastim) following high-dose chemotherapy and peripheral blood progenitor cell rescue in high-grade non-Hodgkin's lymphoma: clinical benefits at no extra cost.

    OpenAIRE

    S.M. Lee; Radford, J. A.; Dobson, L.; Huq, T.; Ryder, W. D.; Pettengell, R; Morgenstern, G. R.; Scarffe, J. H.; Crowther, D.

    1998-01-01

    In order to evaluate the potential clinical and economic benefits of granulocyte colony-stimulating factor (G-CSF, filgrastim) following peripheral blood progenitor cells (PBPC) rescue after high-dose chemotherapy (HDCT), 23 consecutive patients aged less than 60 years with poor-prognosis, high-grade non-Hodgkin's lymphoma (NHL) were entered into a prospective randomized trial between May 1993 and September 1995. Patients were randomized to receive either PBPC alone (n = 12) or PBPC+G-CSF (n ...

  1. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig; Holm, Gitte; Jacobsen, Tine W; Gebuhr, Peter

    2003-01-01

    . PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative......INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed...... blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p...

  2. Randomized trials of high-dose chemotherapy in breast cancer: fraud, the press and the data (or lessons learned in medical policy governing clinical research).

    OpenAIRE

    Antman, Karen

    2002-01-01

    High dose therapy for breast cancer remains controversial. Of the 15 randomized trials of high dose therapy in breast cancer reported to date, two South African studies have been discredited leaving 13 remaining studies. Mortality was consistently low, in the 0 to 2.5% range, except for the BCNU containing American Intergroup study, which had a 7.4% toxic mortality rate. Seven of the remaining 13 studies randomized fewer than 200 patients. Three of these small studies have significant differe...

  3. A phase 2, randomized, double-blind, placebo-controlled trial of clinical activity and safety of subcutaneous Å6 in women with asymptomatic CA125 progression after first-line chemotherapy of epithelial ovarian cancer

    DEFF Research Database (Denmark)

    Ghamande, Sharad A.; Silverman, Michael H.; Huh, Warner;

    2008-01-01

    subcutaneous injections of placebo, low-dose A6 (150 mg), or high-dose A6 (300 mg) until disease progression or end of study participation. Primary endpoints were time to clinical progression of disease and safety of A6. Secondary endpoints were changes in serum CA125 and biomarkers of the urokinase system......OBJECTIVES: A6 is a novel peptide that interferes with single-chain urokinase plasminogen activator activity and has shown anti-angiogenic, anti-migratory, and anti-invasive properties. We evaluated clinical efficacy and safety of subcutaneously administered A6 in women with epithelial ovarian...... cancer. METHODS: Women with epithelial ovarian, fallopian tube, or primary peritoneal cancer in clinical remission after first-line chemotherapy with 2 consecutive increases of CA125 values above normal but with no disease on physical examination or imaging studies were randomly assigned to receive daily...

  4. 'Pragmatic randomized controlled trial of individually prescribed exercise versus usual care in a heterogeneous cancer survivor population': a feasibility study PEACH trial: prescribed exercise after chemotherapy.

    LENUS (Irish Health Repository)

    Walsh, Julie M

    2010-01-01

    BACKGROUND: Many cancer survivors suffer a range of physical and psychological symptoms which may persist for months or years after cessation of treatment. Despite the known benefits of exercise and its potential to address many of the adverse effects of treatment, the role of exercise as well as optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long and have tight eligibility criteria which make them non-applicable to the majority of cancer survivors. This paper presents the protocol of a novel 8-week intervention which aims to increase fitness, and address other physical symptoms in a heterogeneous cancer survivor population. METHODS\\/DESIGN: The aim is to recruit 64 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent. Subjects will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored supervised moderate intensity aerobic exercise sessions weekly over 8-weeks. All participants will be assessed at baseline (0 weeks), at the end of the intervention (8 weeks), and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program. DISCUSSION: This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additionally, process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population post cessation of chemotherapy.

  5. 'Pragmatic randomized controlled trial of individually prescribed exercise versus usual care in a heterogeneous cancer survivor population': A feasibility study PEACH Trial: Prescribed exercise after chemotherapy

    Directory of Open Access Journals (Sweden)

    Guinan Emer

    2010-02-01

    Full Text Available Abstract Background Many cancer survivors suffer a range of physical and psychological symptoms which may persist for months or years after cessation of treatment. Despite the known benefits of exercise and its potential to address many of the adverse effects of treatment, the role of exercise as well as optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long and have tight eligibility criteria which make them non-applicable to the majority of cancer survivors. This paper presents the protocol of a novel 8-week intervention which aims to increase fitness, and address other physical symptoms in a heterogeneous cancer survivor population. Methods/design The aim is to recruit 64 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent. Subjects will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored supervised moderate intensity aerobic exercise sessions weekly over 8-weeks. All participants will be assessed at baseline (0 weeks, at the end of the intervention (8 weeks, and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program. Discussion This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additionally, process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population post cessation of chemotherapy. Trial Registration NCT01030887

  6. A randomized comparative study of antiemetic prophylaxis with ondansentron in a single 32-mg loading dose versus 8 mg every 6 h in patients undergoing cisplatin-based chemotherapy.

    Science.gov (United States)

    Tsavaris, N; Fountzilas, G; Mylonakis, N; Athanassiadis, A; Kosmas, C; Karakousis, C; Bacoyiannis, C; Kosmidis, P

    1998-01-01

    In several studies a single dose of 32 mg was compared to an ondansentron (OND) administration schedule of every 6 h, yielding no differences in overall efficacy. The aim of this randomized comparative study was to identify differences of these two schedules on an hour-to-hour control of nausea and vomiting, during the first 24 h in patients receiving cisplatin (CDDP)-based chemotherapy. One hundred ten patients were randomly assigned to two groups (A and B); all received combination chemotherapy with CDDP at a dose of 100 mg/m2. OND was administered as follows: group A: 8 mg, 30 min before the infusion of CDDP, and repeated every 6 h after the first dose (totally 4 doses) in the first 24 h, and group B: 32 mg before CDDP, as a loading dose and this was the total dose for the first 24 h. No overall difference was noticed during the first 24 h, as well as the next 3 days from the infusion of CDDP in the intensity of vomits, vomits without gastric content (retches), and nausea. In a more detailed monitoring of the distribution of emetic episodes during the first 24 h, there were important differences between these two antiemetic schedules: for group A an increased vomiting with or without gastric content between midnight and 6 p.m. was observed, and for group B between 6 p.m. and midnight (vomits with p 0.03, and without gastric content p 0.02). Preloading with the total 24-hour dose of OND 32 mg exhibits a more potent antiemetic activity during the initial 18 h, becoming weaker over the last 5 h of the first day, whereas the every-6-hour schedule leaves periods of poor emesis control between dosing intervals. PMID:9778615

  7. Short-course chemotherapy for mycobacteriosis kansasii?

    OpenAIRE

    Schraufnagel, D. E.; Leech, J A; Schraufnagel, M. N.; Pollak, B.

    1984-01-01

    The success of short-course chemotherapy for tuberculosis, the similarity between Mycobacterium tuberculosis and M. kansasii and the effectiveness of rifampin against the latter organism prompted a comparison of the diseases due to these organisms to assess the feasibility of a prospective trial of short-course chemotherapy in patients with mycobacteriosis kansasii. The two groups of patients were matched for age, sex and time of diagnosis. The patients with mycobacteriosis kansasii more freq...

  8. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: prospective evaluation of activity, safety, and quality of life

    Directory of Open Access Journals (Sweden)

    Palumbo R

    2015-04-01

    Full Text Available Raffaella Palumbo,1 Federico Sottotetti,1 Giuseppe Trifirò,2 Elena Piazza,3 Antonella Ferzi,4 Anna Gambaro,3 Elena Giulia Spinapolice,2 Emma Pozzi,1 Barbara Tagliaferri,1 Cristina Teragni,1 Antonio Bernardo1 1Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy; 2Unit of Nuclear Medicine, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy; 3Medical Oncology Luigi Sacco Hospital, Milano, Italy; 4Medical Oncology, Legnano Hospital, Legnano, Italy Background: A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC.Patients and methods: Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m2 as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal.Results: All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48% (95% CI, 31.5%–61.3% and included complete responses from 13.5%. Disease stabilization was obtained in 19 patients and lasted >6 months in 15 of them; the overall clinical benefit rate was 77%. The median time to response was 70 days (range 52–86 days. The median progression-free survival time was 8.9 months (95% CI, 8.0–11.6 months, range 5–21+ months. The median overall survival point has not yet been reached. Toxicities were expected and manageable with good

  9. Progressive Resistance Training and Cancer Testis (PROTRACT - Efficacy of resistance training on muscle function, morphology and inflammatory profile in testicular cancer patients undergoing chemotherapy: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mackey Abigail L

    2011-08-01

    Full Text Available Abstract Background Standard treatment for patients with disseminated germ cell tumors is combination chemotherapy with bleomycin, etoposide and cisplatin (BEP. This treatment is highly effective, but the majority of patients experience severe adverse effects during treatment and are at risk of developing considerable long-term morbidity, including second malignant neoplasms, cardiovascular disease, and pulmonary toxicity. One neglected side effect is the significant muscular fatigue mentioned by many patients with testicular cancer both during and after treatment. Very limited information exists concerning the patho-physiological effects of antineoplastic agents on skeletal muscle. The primary aim of this study is to investigate the effects of BEP-treatment on the skeletal musculature in testicular cancer patients, and to examine whether the expected treatment-induced muscular deterioration can be attenuated or even reversed by high intensity progressive resistance training (HIPRT. Design/Methods The PROTRACT study is a randomized controlled trial in 30 testicular cancer patients undergoing three cycles of BEP chemotherapy. Participants will be randomized to either a 9-week HIPRT program (STR initiated at the onset of treatment, or to standard care (UNT. 15 healthy matched control subjects (CON will complete the same HIPRT program. All participants will take part in 3 assessment rounds (baseline, 9 wks, 21 wks including muscle biopsies, maximum muscle strength tests, whole body DXA scan and blood samples. Primary outcome: mean fiber area and fiber type composition measured by histochemical analyses, satellite cells and levels of protein and mRNA expression of intracellular mediators of protein turnover. Secondary outcomes: maximum muscle strength and muscle power measured by maximum voluntary contraction and leg-extensor-power tests, body composition assessed by DXA scan, and systemic inflammation analyzed by circulating inflammatory markers

  10. Progressive Resistance Training and Cancer Testis (PROTRACT) - Efficacy of resistance training on muscle function, morphology and inflammatory profile in testicular cancer patients undergoing chemotherapy: design of a randomized controlled trial

    International Nuclear Information System (INIS)

    Standard treatment for patients with disseminated germ cell tumors is combination chemotherapy with bleomycin, etoposide and cisplatin (BEP). This treatment is highly effective, but the majority of patients experience severe adverse effects during treatment and are at risk of developing considerable long-term morbidity, including second malignant neoplasms, cardiovascular disease, and pulmonary toxicity. One neglected side effect is the significant muscular fatigue mentioned by many patients with testicular cancer both during and after treatment. Very limited information exists concerning the patho-physiological effects of antineoplastic agents on skeletal muscle. The primary aim of this study is to investigate the effects of BEP-treatment on the skeletal musculature in testicular cancer patients, and to examine whether the expected treatment-induced muscular deterioration can be attenuated or even reversed by high intensity progressive resistance training (HIPRT). The PROTRACT study is a randomized controlled trial in 30 testicular cancer patients undergoing three cycles of BEP chemotherapy. Participants will be randomized to either a 9-week HIPRT program (STR) initiated at the onset of treatment, or to standard care (UNT). 15 healthy matched control subjects (CON) will complete the same HIPRT program. All participants will take part in 3 assessment rounds (baseline, 9 wks, 21 wks) including muscle biopsies, maximum muscle strength tests, whole body DXA scan and blood samples. Primary outcome: mean fiber area and fiber type composition measured by histochemical analyses, satellite cells and levels of protein and mRNA expression of intracellular mediators of protein turnover. Secondary outcomes: maximum muscle strength and muscle power measured by maximum voluntary contraction and leg-extensor-power tests, body composition assessed by DXA scan, and systemic inflammation analyzed by circulating inflammatory markers, lipid and glucose metabolism in blood samples

  11. Comparison of efficacy for postoperative chemotherapy and concurrent radiochemotherapy in patients with IIIA-pN2 non-small cell lung cancer: An early closed randomized controlled trial

    International Nuclear Information System (INIS)

    Objective: The efficacy of postoperative concurrent radiochemotherapy (POCRT) on IIIA-pN2 non-small cell lung cancer (NSCLC) is still unclear. The aim of this randomized controlled trial was to compare POCRT with postoperative chemotherapy (POCT) alone in terms of survival and relapse patterns. Methods: Patients with completely resected IIIA-pN2 NSCLC were randomized into POCRT or POCT groups. Chemotherapy consisted of paclitaxel (175 mg/m2) and cisplatin (60 mg/m2) administered intravenously for four cycles on day 1, 22, 43, and 64. Patients in the POCRT group received radiotherapy (50.4 Gy/28 fractions) concurrently with the first 2 cycles of chemotherapy. Results: This study recruited 140 participants and was closed early because of slow accrual. Data were analyzed for 135 of them including 66 cases in the POCRT group and 69 cases in the POCT group. Patients were followed-up for a median period of 45 months. The POCRT group had a median survival (MS) of 40 months and a 5-year overall survival (OS) rate of 37.9%. The POCT group had a MS of 28 months and a 5-year OS rate of 27.5%. The hazard ratio for death in the POCRT group was 0.69 (95% CI: 0.457–1.044, P = 0.073). We observed a disease-free survival (DFS) of 28 months and a 5-year DFS rate of 30.3% in the POCRT group. Likewise, we observed a DFS of 18 months and a 5-year DFS rate of 18.8% in the POCT group. The recurrence hazard ratio in the POCT group was 1.49 (95% CI: 1.008–2.204, P = 0.041). Subgroup analysis revealed that POCRT significantly increased the OS rate of the patients with ⩾2 pN2 lymph nodes (P = 0.021). The POCRT group had a significantly lower local relapse (P = 0.009) and distant metastasis (P = 0.05) rates as compared to that of the POCT group. One case died of pyemia and 9 cases suffered from grade 3 and 4 acute radiation esophagitis. The two groups had similar and tolerable hematologic toxicities. Conclusions: Compared with POCT, POCRT increased both local/regional and distant DFS

  12. A prospective study of the efficacy of a combination of autologous dendritic cells, cytokine-induced killer cells, and chemotherapy in advanced non-small cell lung cancer patients.

    Science.gov (United States)

    Zhong, Runbo; Han, Baohui; Zhong, Hua

    2014-02-01

    Dendritic cells (DC) play a crucial role in the induction of an effective antitumor immune response. Cytokine-induced killer (CIK) cells, a subset of T lymphocytes, have the capacity to eliminate cancer cells. This study was to evaluate the correlation between the frequency of DC/CIK immunotherapies following regular chemotherapy, the time-to-progression (TTP), and overall survival (OS) of advanced non-small lung cancer patients. Sixty patients with IIIB-IV non-small-cell lung carcinoma (NSCLC) were enrolled from August 2007 to December 2009 and were randomized into two groups. All 60 patients received four courses of navelbine-platinum (NP) chemotherapy. In one group, 30 patients were treated with adoptive autologous DC/CIK cell transfusion twice every 30 days. In the other group, the patients received immunotherapies more than twice every 30 days. The adverse effects, TTP, and OS were evaluated between the two groups. Median survival time of all 60 patients was 13.80 months. The 1-, 2-, and 3-year overall survival rates were 60.0, 21.7, and 15.0 %, respectively. The 1-, 2-, and 3-year overall survival rates of patients receiving more than two immunotherapies were 63.3, 30.0, and 23.3 %, and the rates of those receiving two immunotherapies were 56.7, 13.3, and 6.7 %, respectively. The difference between the two groups was statistically significant (P = 0.037). Compared with patients in the fewer immunotherapies group, TTP in the group receiving more immunotherapies significantly prolonged, with the median improving from 6.2 months (95 % CI, 5.35-9.24) to 7.3 months (95 % CI, 5.45-6.95; P = 0.034). The adverse effects of chemoimmunotherapy were tolerable. Advanced NSCLC patients can benefit from the combination of DC/CIK immunotherapies following conventional chemotherapy. More than two immunotherapies improved TTP and OS of those patients in this study. PMID:24006222

  13. Patient-Reported Voice and Speech Outcomes After Whole-Neck Intensity Modulated Radiation Therapy and Chemotherapy for Oropharyngeal Cancer: Prospective Longitudinal Study

    International Nuclear Information System (INIS)

    Purpose: To describe voice and speech quality changes and their predictors in patients with locally advanced oropharyngeal cancer treated on prospective clinical studies of organ-preserving chemotherapy–intensity modulated radiation therapy (chemo-IMRT). Methods and Materials: Ninety-one patients with stage III/IV oropharyngeal cancer were treated on 2 consecutive prospective studies of definitive chemoradiation using whole-field IMRT from 2003 to 2011. Patient-reported voice and speech quality were longitudinally assessed from before treatment through 24 months using the Communication Domain of the Head and Neck Quality of Life (HNQOL-C) instrument and the Speech question of the University of Washington Quality of Life (UWQOL-S) instrument, respectively. Factors associated with patient-reported voice quality worsening from baseline and speech impairment were assessed. Results: Voice quality decreased maximally at 1 month, with 68% and 41% of patients reporting worse HNQOL-C and UWQOL-S scores compared with before treatment, and improved thereafter, recovering to baseline by 12-18 months on average. In contrast, observer-rated larynx toxicity was rare (7% at 3 months; 5% at 6 months). Among patients with mean glottic larynx (GL) dose ≤20 Gy, >20-30 Gy, >30-40 Gy, >40-50 Gy, and >50 Gy, 10%, 32%, 25%, 30%, and 63%, respectively, reported worse voice quality at 12 months compared with before treatment (P=.011). Results for speech impairment were similar. Glottic larynx dose, N stage, neck dissection, oral cavity dose, and time since chemo-IMRT were univariately associated with either voice worsening or speech impairment. On multivariate analysis, mean GL dose remained independently predictive for both voice quality worsening (8.1%/Gy) and speech impairment (4.3%/Gy). Conclusions: Voice quality worsening and speech impairment after chemo-IMRT for locally advanced oropharyngeal cancer were frequently reported by patients, underrecognized by clinicians, and

  14. Patient-Reported Voice and Speech Outcomes After Whole-Neck Intensity Modulated Radiation Therapy and Chemotherapy for Oropharyngeal Cancer: Prospective Longitudinal Study

    Energy Technology Data Exchange (ETDEWEB)

    Vainshtein, Jeffrey M. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Center for Cancer Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan (United States); Feng, Felix Y.; Vineberg, Karen A. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Chepeha, Douglas B. [Department of Otolaryngology–Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan (United States); Eisbruch, Avraham, E-mail: eisbruch@umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2014-08-01

    Purpose: To describe voice and speech quality changes and their predictors in patients with locally advanced oropharyngeal cancer treated on prospective clinical studies of organ-preserving chemotherapy–intensity modulated radiation therapy (chemo-IMRT). Methods and Materials: Ninety-one patients with stage III/IV oropharyngeal cancer were treated on 2 consecutive prospective studies of definitive chemoradiation using whole-field IMRT from 2003 to 2011. Patient-reported voice and speech quality were longitudinally assessed from before treatment through 24 months using the Communication Domain of the Head and Neck Quality of Life (HNQOL-C) instrument and the Speech question of the University of Washington Quality of Life (UWQOL-S) instrument, respectively. Factors associated with patient-reported voice quality worsening from baseline and speech impairment were assessed. Results: Voice quality decreased maximally at 1 month, with 68% and 41% of patients reporting worse HNQOL-C and UWQOL-S scores compared with before treatment, and improved thereafter, recovering to baseline by 12-18 months on average. In contrast, observer-rated larynx toxicity was rare (7% at 3 months; 5% at 6 months). Among patients with mean glottic larynx (GL) dose ≤20 Gy, >20-30 Gy, >30-40 Gy, >40-50 Gy, and >50 Gy, 10%, 32%, 25%, 30%, and 63%, respectively, reported worse voice quality at 12 months compared with before treatment (P=.011). Results for speech impairment were similar. Glottic larynx dose, N stage, neck dissection, oral cavity dose, and time since chemo-IMRT were univariately associated with either voice worsening or speech impairment. On multivariate analysis, mean GL dose remained independently predictive for both voice quality worsening (8.1%/Gy) and speech impairment (4.3%/Gy). Conclusions: Voice quality worsening and speech impairment after chemo-IMRT for locally advanced oropharyngeal cancer were frequently reported by patients, underrecognized by clinicians, and

  15. Combination chemotherapy with paclitaxel, cisplatin and fluorouracil for patients with advanced and metastatic gastric or esophagogastric junction adenocarcinoma: a multicenter prospective study

    Institute of Scientific and Technical Information of China (English)

    Xiao-Dong Zhang; Cheng-Ye Guo; Lin Shen; Mao-Lin Jin; Yong-Qian Shu; Jun Liang; Feng-Chun Zhang; Xue-Zhen Ma; Jian-Jin Huang; Li Chen; Gen-Ming Shi; Wei-Guo Cao

    2012-01-01

    Objective:To evaluate the efficacy and toxicity of the combination regimen of paclitaxel,cisplatin and 5-FU (PCF) as first-line or second-line therapy in patients with advanced gastric and esophagogastric junction (EGJ) adenocarcinoma in China.Methods:The patients were treated with paclitaxel 150 mg/m2 on d1; fractionated cisplatin 15 mg/m2 and continuous infusion 5-FU 600 mg/(m2·d) intravenously on d1-d5 of a 21-d cycle until disease progression or unacceptable toxicities.Results:Seventy-five patients have been enrolled,among which,41 received PCF regimen as the first-line therapy (group A) and 34 received the regimen as the second-line therapy (group B) with the median age of 59 years old and Karnofsky performance status (KPS) score ≥80.Toxicities were analyzed in all 75 patients.Seventy-one patients were evaluable for efficacy.The median overall survival (mOS) was 12.0 months (95% CI:7.9-16.2 months) in group A and 7.3 months (95% CI:4.3-10.3 months) in group B,respectively.The median progression-free survival (mPFS) was 5.7 months (95% CI:4.1-7.2 months) and 5.0 months (95% CI:3.1-6.9 months),respectively.The response rate (CR+PR) was 40% (16/40; 95% CI:24.9-56.7%) in group A and 22.6% (7/31; 95% CI:9.6-41.1%) in group B.Major grade 3 or 4 adverse events include neutropenia (41.3%),febrile neutropenia (9.3%),nausea/anorexia (10.7%),and vomiting (5.3%).There was no treatment-related death.Conclusions:The combination chemotherapy with PCF is active and tolerable as first-line and second-line therapy in Chinese patients with advanced gastric and EGJ adenocarcinoma.The response and survival of PCF are same as those of DCF,but the tolerance is much better.

  16. A prospective randomized study of conservative versus surgical treatment of unstable palmar plate disruption in the proximal interphalangeal finger joint

    DEFF Research Database (Denmark)

    Werlinrud, Jens Christian; Petersen, Kirstin; Lauritsen, Jens; Larsen, Søren; Schrøder, Henrik

    The aim of this study was to assess the effect of conservative versus operative treatment for unstable palmar plate disruption in the proximal interphalangeal (PIP) joint of the fingers with respect to preservation of joint stability, mobility, and pain. The study was conducted as a prospective s...... do not recommend primary surgical repair of unstable isolated palmar plate lesions in the proximal interphalangeal joints of the 4 ulnar fingers. Type of study/level of evidence Therapeutic, Level II....

  17. Guidelines for chemotherapy of biliary tract and ampullary carcinomas

    OpenAIRE

    Furuse, Junji; Takada, Tadahiro; Miyazaki, Masaru; Miyakawa, Shuichi; Tsukada, Kazuhiro; Nagino, Masato; Kondo, Satoshi; Saito, Hiroya; Tsuyuguchi, Toshio; Hirata, Koichi; Kimura, Fumio; Yoshitomi, Hideyuki; Nozawa, Satoshi; YOSHIDA, Masahiro; Wada, Keita

    2008-01-01

    Few randomized controlled trials (RCTs) with large numbers of patients have been conducted to date in patients with biliary tract cancer, and standard chemotherapy has not been established yet. In this article we review previous studies and clinical trials regarding chemotherapy for unresectable biliary tract cancer, and we present guidelines for the appropriate use of chemotherapy in patients with biliary tract cancer. According to an RCT comparing chemotherapy and best supportive care for t...

  18. Naso pharyngeal carcinoma. Modalities of radiation therapy and combinations of radiotherapy and chemotherapy: state of art and perspectives

    International Nuclear Information System (INIS)

    Nasopharyngeal carcinoma (NPC) is a highly radiosensitive and chemo-sensitive. In the patient with locally advanced tumours, the results of conventional radiotherapy are unsatisfactory with significant rates of both local recurrences and distant metastases. The aim of this review is to report the innovative strategies for treatment of the nasopharyngeal carcinoma. Altered fractionation techniques can improve local control. The impact of the innovative techniques, including conformal radiation, stereotactic radiation and IMRT, on survival, must be evaluated in randomized trials. The encouraging early results obtained with concurrent (more than sequential) chemotherapy and radiotherapy must be confirmed in prospective randomized trial in endemic areas. (authors)

  19. Priming with r-metHuSCF and filgrastim or chemotherapy and filgrastim in patients with malignant lymphomas: a randomized phase II pilot study of mobilization and engraftment

    DEFF Research Database (Denmark)

    Johnsen, H E; Geisler, C; Juvonen, E;

    2011-01-01

    SCF has been shown to synergize with G-CSF to mobilize CD34(+) PBPCs. In this study we report results from this combination after a phase II trial of 32 patients with malignant lymphoma randomized to receive recombinant methionyl human SCF (ancestim, r-metHuSCF) in combination with recombinant me...

  20. The antiemetic efficacy of tropisetron plus dexamethasone as compared with conventional metoclopramide-dexamethasone combination in Orientals receiving cisplatin chemotherapy: a randomized crossover trial

    OpenAIRE

    CHUA, D. T. T.; Sham, J S T; AU, G. K. H.; Choy, D; Kwong, D L W; Yau, C C; CHENG, A. C. K.

    1996-01-01

    1We report a single-blind randomized crossover trial comparing the efficacy of tropisetron plus dexamethasone (TROPDEX) vs conventional combination of metoclopramide, dexamethasone and diphenhydramine (METDEX) in prevention of acute and delayed vomiting in Chinese patients receiving high dose cisplatin.

  1. Chemotherapy for Testicular Cancer

    Science.gov (United States)

    ... chemotherapy and stem cell transplant for testicular cancer Chemotherapy for testicular cancer Chemotherapy (chemo) is the use ... Symptoms of Cancer Treatments & Side Effects Cancer Facts & Statistics News About Cancer Expert Voices Blog Programs & Services ...

  2. Types of chemotherapy

    Science.gov (United States)

    Chemotherapy is the use of medicine to treat cancer. Chemotherapy kills cancer cells. It may be used to ... people are treated with a single type of chemotherapy. But often, people get more than one type ...

  3. Types of chemotherapy

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000910.htm Types of chemotherapy To use the sharing features on this page, ... or on cancer cells. How Doctors Choose Your Chemotherapy The type and dose of chemotherapy your doctor ...

  4. Chemotherapy for Thyroid Cancer

    Science.gov (United States)

    ... cancer Next Topic Targeted therapy for thyroid cancer Chemotherapy for thyroid cancer Chemotherapy (chemo) uses anti-cancer drugs that are injected ... vein or muscle, or are taken by mouth. Chemotherapy is systemic therapy, which means that the drug ...

  5. Locally advanced cervix cancer: chemotherapy prior to definitive surgery or radiotherapy. A single institutional experience

    International Nuclear Information System (INIS)

    Primary or neoadjuvant chemotherapy prior to definitive local therapy has potential advantages for locally advanced cervix cancer. It can down stage a cancer and allow definitive local therapy to be technically possible (surgery), or potentially more effective (radiotherapy). It can also eradicate subclinical systemic metastases. This report reviews a single institution's experience of neoadjuvant chemotherapy prior to definitive local therapy for cervix cancer over a 13-year period. One hundred and six patients were treated with this intent. The patients were analysed for their response to chemotherapy, treatment received, survival, relapse and toxicity. The chemotherapy was feasible and the majority of patients had a complete or partial response (58.5%). Eight patients did not proceed to local treatment. Forty-six patients had definitive surgery and 52 had definitive radiotherapy. The 5-year overall survival was 27% and the majority of patients died with disease. The first site of relapse was usually in the pelvis (46.2%). Late complications that required ongoing medical therapy (n = 6) or surgical intervention (n = 2) were recorded in eight patients (7.5%). On univariate analysis stage (P= 0.04), tumour size (P = 0.01), lymph node status (P=0.003), response to chemotherapy (P = 0.045) and treatment (P = 0.003) were all significant predictors of survival. On multivariate analysis, tumour size (P < 0.0001) and nodal status (P = 0.02) were significant predictors of survival. Despite the impressive responses to chemotherapy of advanced cervix cancer, there is evidence from randomized trials that it does not improve or compromise survival prior to radiotherapy. As its role prior to surgery remains unclear, it should not be used in this setting outside a prospective randomized trial. Copyright (2001) Blackwell Science Pty Ltd

  6. Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES):A randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue

    NARCIS (Netherlands)

    Waart, van Hanna; Stuiver, Martijn M.; Harten, van Wim H.; Sonke, Gabe S.; Aaronson, Neil K.

    2010-01-01

    Background: Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may con

  7. Design of the physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES): a randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue

    NARCIS (Netherlands)

    H. van Waart; M.M. Stuiver; W.H. van Harten; G.S. Sonke; N.K. Aaronson

    2010-01-01

    Background Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may cont

  8. chemotherapy patients

    Directory of Open Access Journals (Sweden)

    Katarzyna Augustyniuk

    2016-02-01

    Full Text Available Background . Complementary and alternative medicine (CAM practices for cancer have become popular among oncology patients. An increasing interest in alternative medicine can be explained by the inefficiency of conventional treatment, dissatisfaction with treating patients like objects, and the will to use all available treatment methods. Objectives . The authors assessed how often patients use CAM methods, and which of them are most popular. Material and methods . The study was conducted in Military Hospital no. 109 and the Independent Public Clinical Hospital no. 1 in Szczecin among 100 chemotherapy patients. This survey-based study was performed using an original questionnaire. Results. Most respondents (68% did not use alternative methods to fight the disease. The most popular treatment methods were: herbal medicine (50%, alternative medicine preparations (38% and diet (25%, and the least common: hypnosis (3% and aromatherapy (3%. Analyzed sociodemographic factors had no effects on a choice of a CAM method. Patients obtained information about CAM methods mainly from the Internet (40%, medical staff (37% and literature (31%. Conclusions . 1. Using CAM by patients receiving chemotherapy for neoplasms is quite a common phenomenon. 2. CAM were more often chosen by women. Neither the duration of the disease nor sociodemographic data had effects on making the decision to use CAM methods. 3. The most popular CAM were: herbal medicine, alternative medicine preparations, and diet. 4. Cancer patients should receive special support from nurses and doctors as well as other members of the therapeutic team. Oncology patients should never be left on their own so that they were forced to seek help and support in therapies unconfirmed by scientific investigation.

  9. Impact of treatment with bevacizumab beyond disease progression: a randomized phase II study of docetaxel with or without bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced nonsquamous non–small cell lung cancer (WJOG 5910L)

    International Nuclear Information System (INIS)

    Bevacizumab, a humanized antibody to vascular endothelial growth factor (VEGF), shows clinical activity against human cancer, with its addition to standard chemotherapy having been found to improve outcome in patients with advanced nonsquamous non–small cell lung cancer (NSCLC). However, there have been no evidence-based studies to support the continued use of bevacizumab beyond disease progression in such patients treated with the drug in first-line therapy. We have now designed a randomized phase II trial to examine the clinical benefit and safety of continued bevacizumab treatment in patients with advanced nonsquamous NSCLC whose disease has progressed after first-line treatment with bevacizumab plus a platinum-based doublet. WJOG 5910L was designed as a multicenter, open-label, randomized, phase II trial by the West Japan Oncology Group of docetaxel (arm A) versus docetaxel plus bevacizumab (arm B) in patients with recurrent or metatstatic nonsquamous NSCLC whose disease has progressed after first-line treatment with bevacizumab plus a platinum-based doublet. Patients in arm A will receive docetaxel at 60 mg/m2 and those in arm B will receive docetaxel at 60 mg/m2 plus bevacizumab at 15 mg/kg, with each drug administered on day 1 every 21 days until progression or unacceptable toxicity. The primary endpoint of the study is progression-free survival, with secondary endpoints including response rate, overall survival, and safety, for patients treated in either arm. UMIN (University Hospital Medical Information Network in Japan) 000004715

  10. ERCC1 as a biomarker for bladder cancer patients likely to benefit from adjuvant chemotherapy

    International Nuclear Information System (INIS)

    The role of adjuvant chemotherapy and the value of molecular biomarkers in bladder cancer have not been determined. We aimed to assess the predictive and prognostic values of excision repair cross-complementation 1 (ERCC1) in identifying appropriate patients who may potentially benefit from adjuvant chemotherapy for bladder cancer. A retrospective analysis was performed on 93 patients with completely resected transitional cell carcinoma of the bladder. ERCC1 expression was assessed by immunohistochemistry. ERCC1 expression was analyzed in 57 patients treated with adjuvant gemcitabine plus cisplatin chemotherapy and 36 who were not treated. Among 93 patients, ERCC1 expression was positive in 54 (58.1%) and negative in 39 (41.9%). ERCC1 positivity was significantly associated with longer survival (adjusted hazard ratio for death, 0.12, 95% confidence interval [CI] 0.014-0.99; P = 0.049) in the group without adjuvant chemotherapy while ERCC1 positivity was associated with shorter survival among patients who have received adjuvant chemotherapy (adjusted hazard ratio for death, 2.64; 95% CI 1.01-6.85; P = 0.047). Therefore, clinical benefit from adjuvant chemotherapy was associated with ERCC1 negativity as measured by overall survival (test for interaction, P = 0.034) and by disease-free survival (test for interaction, P = 0.20). Among patients with completely resected transitional cell carcinoma of the bladder, those with ERCC1-negative tumors seemed to benefit more from adjuvant gemcitabine plus cisplatin chemotherapy than those with ERCC1-positive tumors. Future prospective, randomized studies are warranted to confirm our findings

  11. A randomized phase II study of SRL172 (Mycobacterium vaccae) combined with chemotherapy in patients with advanced inoperable non-small-cell lung cancer and mesothelioma

    OpenAIRE

    O’Brien, M E R; Saini, A.; Smith, I. E.; Webb, A.; Gregory, K.; Mendes, R.; Ryan, C.; Priest, K.; Bromelow, K V; Palmer, R. D.; Tuckwell, N; Kennard, D A; Souberbielle, B. E.

    2000-01-01

    Mycobacterial preparations have been used with limited success against cancer apart from superficial bladder cancer. Recently, a therapeutic vaccine derived from Mycobacterium vaccae has been given to patients with prostate cancer and melanoma indicating a possible beneficial effect on disease activity in such patients. We have recently initiated a series of randomized studies to test the feasibility and toxicity of combining a preparation of heat-killed Mycobacterium vaccae (designated SRL17...

  12. Football as a treatment for hypertension in untrained 30-55-year-old men: a prospective randomized study

    DEFF Research Database (Denmark)

    Andersen, L J; Randers, M B; Westh, K;

    2010-01-01

    The present study investigated whether football has favorable effects in the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men. Twenty-five untrained males aged 31-54 year with mild-to-moderate hypertension were randomized to a football training group (FTG, two 1-h ...

  13. Moist wound healing compared with standard care of treatment of primary closed vascular surgical wounds: a prospective randomized controlled study

    DEFF Research Database (Denmark)

    Vogt, Katja C; Uhlyarik, M; Schroeder, Torben V

    2007-01-01

    This study was a randomized-controlled trial comparing the standard type of dry dressing, Mepore, with moist wound healing, using a hydrofiber dressing, Aquacel, in primary closed wounds after vascular surgery. The endpoints were patient comfort, cost-effectiveness, infections, wound complication...

  14. Impact of aerobic exercise training during chemotherapy on cancer related cognitive impairments in patients suffering from acute myeloid leukemia or myelodysplastic syndrome - Study protocol of a randomized placebo-controlled trial.

    Science.gov (United States)

    Zimmer, P; Oberste, M; Bloch, W; Schenk, A; Joisten, N; Hartig, P; Wolf, F; Baumann, F T; Garthe, A; Hallek, M; Elter, T

    2016-07-01

    Cancer related cognitive impairments (CRCI) are frequently reported by patients prior to, during and after medical treatment. Although this cognitive decline severely affects patients' quality of life, little is known about effective treatments. Exercise programs represent a promising supportive strategy in this field. However, evidence is sparse and existing studies display methodological limitations. In the planned study, 83 men and women newly diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) will be randomized into one of three treatment groups. During 4weeks of induction chemotherapy with Anthracycline and Cytarabin patients allocated to exercise group will cycle 3×/week for 30min at moderate to vigorous intensity on an ergometer. Patients allocated to placebo group will receive a supervised myofascial release training (3×/week, approx. 30min) and patients at control group will get usual care. As primary endpoints a cognitive test battery will be conducted measuring performances depending on verbal/spatial memory and executive functioning. Secondary endpoints will be self-perceived cognitive functioning, as well as neurotrophic and inflammatory serum markers. All assessments will be conducted immediately after hospitalization and before chemotherapy is commenced, immediately before discharge of hospital after 4-5weeks as well as before continuing medical treatment 3-4weeks after discharge. This will be the first study investigating the impact of an aerobic exercise training on CRCI in AML/MDS patients. We hope that the study design and the state-of-the-art assessments will help to increase knowledge about CRCI in general and exercise as potential treatment option in this under investigated population. PMID:27261170

  15. Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens

    OpenAIRE

    Hingmire Sachin; Raut Nirmal

    2015-01-01

    Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian population with aprepitant containing regimens. Aims: The aim was to assess the Efficacy and Safety of Aprepitant for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy/moderately emetogenic chemotherapy (HEC/MEC) regimens. Settings and Design: Investigator initiated, multicentric, open-label, prospective, noncomparative, observational tria...

  16. Randomize Trial of Cisplatin plus Gemcitabine with either Sorafenib or Placebo as First-line Therapy for Non-small Cell Lung Cancer

    OpenAIRE

    Yan WANG; Wang, Lin; Liu, Yutao; Shufei YU; Xiangru ZHANG; Shi, Yuankai; Sun, Yan

    2011-01-01

    Background and objective Platinum-based chemotherapy doublets reached an efficacy plateau in nonsmall-cell lung cancer (NSCLC). This randomized controlled study prospectively assessed the efficacy and safety of cisplatin plus gemcitabine with either Sorafenib or placebo as first-line therapy for NSCLC. Methods Thirty patients, which were confirmed advanced NSCLC histologically or cytologically, were randomly assigned to receive up to six cycles of cisplatin plus gemcitabine with sorafenib or ...

  17. Management of stage one and two-E gastric large B-cell lymphoma: chemotherapy alone or surgery followed by chemotherapy?

    Directory of Open Access Journals (Sweden)

    Kadiri Habiba

    2010-06-01

    Full Text Available Abstract Management of localized primary gastric B lymphoma (PGL remains controversial. The aim of this study is to compare two treatments: chemotherapy alone and surgery plus chemotherapy. Materials Records of all patients with a diagnosis of gastric lymphoma and which were treated in the National Institute of Oncology, between 1999 and 2006, were reviewed and patients fulfilling the following criteria were included in this study: histologically proven large-cell B lymphoma of the stomach; complete clinical information stage I/II disease according to the Musshoff staging; patients who received surgery followed by chemotherapy (group I or chemotherapy alone (group II. Results This study included 82 patients who were treated for cancer in our Institute. All clinical and pathological features were similar between the two groups, except that patients of group-I had significantly more stage II disease (P = 0.023 than that of group II. Among the 52 patients who could be evaluated for response to chemotherapy, there were 45 who had complete response to treatment, 3 had partial response to the treatment and 4 had progressive disease. The projected 5-year relapse-free survival (RFS and overall survival (OS of group I were 86.69% (95% CI, 57.9 - 97.7% and 90.0% (95% CI, 58.0 - 97.8%, respectively. And the projected 5-year relapse-free survival RFS and OS of group II were 86.67% (95% CI, 57.0 - 88.2% and 93.33% (95% CI, 73.3 - 98.7% respectively. There were no statistically significant differences in RFS (P = 0.485 and OS (P = 0.551 between the two groups. Conclusion Our data suggest that chemotherapy alone may be a reasonable alternative treatment for stage I/II gastric large-cell lymphoma but this result must be confirmed by prospective randomized clinical trials.

  18. Effect of decompression surgery on neurological recovery after cervical cord injury with canal stenosis but without distinct bony damage. Multicenter prospective randomized clinical trial

    International Nuclear Information System (INIS)

    A prospective randomized clinical trial examining the effects of decompression surgery on neurological recovery in patients with cervical cord injuries without remarkable bony damages was performed at 11 hospitals nationwide in Japan. Cases admitted within 14 days of injury, with a Frankel B or C classification, and with ≥20% compression of the spinal cord at the injured level, as seen on MRI, were enrolled. Decompression surgery was selected for cases in which the day of injury was an odd number, while conservative treatment was selected for all other cases. The Frankel classification and ASIA motor scores were followed for one year after injury. No statistically significant differences in neurological recovery were observed between the surgery group and the conservative treatment group. (author)

  19. A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy. A secondary analysis

    International Nuclear Information System (INIS)

    The aim of this study was to determine the impact of bethanechol administration concomitant to radiotherapy (RT) on oral mucositis, candidiasis and taste loss. We performed a secondary analysis of a previously conducted prospective randomized trial which evaluated the effect of bethanechol on salivary gland dysfunction before, during, and after RT for head and neck cancer (HNC), in comparison to artificial saliva. Mucositis, candidiasis and taste loss were analyzed in 36 patients. Mucositis was scored using the World Health Organization (WHO) method; candidiasis was diagnosed by means of clinical examination, whereas taste loss was assessed by the patients' subjective report of absence of taste. No significant differences were observed between groups in relation to frequency and severity of mucositis or frequency of candidiasis and taste loss. In conclusion, bethanechol does not appear to reduce the incidence of mucositis, candidiasis, and taste loss when administered during RT. (author)

  20. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

    DEFF Research Database (Denmark)

    Qintar, Mohammed; George, Jason J; Panko, Melanie;

    2015-01-01

    PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study...... consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS......) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1. RESULTS: The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD...

  1. Randomized, prospective, three-arm study to confirm the auditory safety and efficacy of artemether-lumefantrine in Colombian patients with uncomplicated Plasmodium falciparum malaria.

    Science.gov (United States)

    Carrasquilla, Gabriel; Barón, Clemencia; Monsell, Edwin M; Cousin, Marc; Walter, Verena; Lefèvre, Gilbert; Sander, Oliver; Fisher, Laurel M

    2012-01-01

    The safety of artemether-lumefantrine in patients with acute, uncomplicated Plasmodium falciparum malaria was investigated prospectively using the auditory brainstem response (ABR) and pure-tone thresholds. Secondary outcomes included polymerase chain reaction-corrected cure rates. Patients were randomly assigned in a 3:1:1 ratio to either artemether-lumefantrine (N = 159), atovaquone-proguanil (N = 53), or artesunate-mefloquine (N = 53). The null hypothesis (primary outcome), claiming that the percentage of patients with a baseline to Day-7 ABR Wave III latency increase of > 0.30 msec is ≥ 15% after administration of artemether-lumefantrine, was rejected; 2.6% of patients (95% confidence interval: 0.7-6.6) exceeded 0.30 msec, i.e., significantly below 15% (P 95% to Day 42. The results support the continued safe and efficacious use of artemether-lumefantrine in uncomplicated falciparum malaria. PMID:22232454

  2. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial

    International Nuclear Information System (INIS)

    Hepatic resection is currently still the best choice of therapeutic strategies for liver cancer, but the long-term survival rate after surgery is unsatisfactory. Most patients develop intra- and/or extrahepatic recurrence. The reasons for this high recurrence rate are not entirely clear. Recent studies have indicated that ischemia-reperfusion injury to the liver may be a significant factor promoting tumor recurrence and metastasis in animal models. If this is also true in humans, the effects of the Pringle maneuver, which has been widely used in hepatectomy for the past century, should be examined. To date, there are no reported data or randomized controlled studies examining the relationship between use of the Pringle maneuver and local tumor recurrence. We hypothesize that the long-term prognosis of patients with liver cancer could be worsened by use of the Pringle maneuver due to an increase in the rate of tumor recurrence in the liver remnant. We designed a multicenter, prospective, randomized surgical trial to test this hypothesis. At least 498 eligible patients from five participating centers will be enrolled and randomized into either the Pringle group or the non-Pringle group in a ratio of 1:1 using a permuted-blocks randomization protocol. After the completion of surgical intervention, patients will be included in a 3-year follow-up program. This multicenter surgical trial will examine whether the Pringle maneuver has a negative effect on the long-term outcome of hepatocellular carcinoma patients. The trial will also provide information about prognostic differences, safety, advantages and disadvantages between Pringle and non-Pringle surgical procedures. Ultimately, the results will increase the available information about the effects of ischemia-reperfusion injury on tumor recurrence, which will be of immense benefit to general surgery.

  3. Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Koes Bart W

    2009-05-01

    Full Text Available Abstract Background The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD. This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18–70 years visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as

  4. Intraoperative music reduces perceived pain after total knee arthroplasty: a blinded, prospective, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Simcock, Xavier C; Yoon, Richard S; Chalmers, Peter; Geller, Jeffrey A; Kiernan, Howard A; Macaulay, William

    2008-10-01

    Patients undergoing total knee arthroplasty (TKA) often experience a difficult recovery due to severe postoperative pain. Using a multimodal pain management protocol, a blinded, randomized, placebo-controlled study was designed to evaluate the efficacy of patient-selected music on reducing perceived pain. Thirty patients undergoing primary unilateral TKA were enrolled and randomized into the music group (15 patients) or the control group (15 patients). Postoperative pain scores, assessed with the visual analog scale, indicated the music group experienced less pain at 3 and 24 hours postoperatively than did the nonmusic group (at 3 hours: 1.47+/-1.39 versus 3.87+/-3.44, P=.01; at 24 hours: 2.41+/-1.67 versus 4.03+/-2.89, P=.04). Intraoperative music provides an inexpensive nonpharmacological option to further reduce postoperative pain. PMID:18979928

  5. A Randomized 10-year Prospective Follow-up of Class II Nanohybrid and Conventional Hybrid Resin Composite Restorations

    DEFF Research Database (Denmark)

    van Dijken, Jan Wv; Pallesen, Ulla

    2014-01-01

    Purpose: To evaluate the 10-year durability of a nanohybrid resin composite in Class II restorations in a randomized controlled intraindividual comparison with its conventional hybrid resin composite predecessor. Materials and Methods: Each of 52 participants received at least two Class II...... restorations that were as similar as possible. The cavities were chosen at random to be restored with a nanohybrid resin composite (Excite/Tetric EvoCeram (TEC); n = 61) and a conventional hybrid (Excite/Tetric Ceram (TC); n = 61). The restorations were evaluated with slightly modified USPHS criteria at...... baseline and then annually for 10 years. The overall performance of the experimental restorations was tested after intra-individual comparison and their ranking was tested using Friedman's two-way ANOVA. The level of significance was set at 5%. Results: Four patient drop-outs with 8 restorations (4TEC, 4TC...

  6. Randomized prospective study comparing a single radioiodine dose and a single laser therapy session in autonomously functioning thyroid nodules

    DEFF Research Database (Denmark)

    Døssing, Helle; Bennedbaek, Finn Noe; Bonnema, Steen Joop;

    2007-01-01

    OBJECTIVE: To compare the efficacy of interstitial laser photocoagulation (ILP) with radioiodine in hot thyroid nodules. DESIGN: Thirty consecutive outpatients with subclinical or mild hyperthyroidism and a scintigraphically solitary hot nodule with extraglandular suppression were randomized to...... effects were seen. CONCLUSIONS: This first randomized study, comparing ILP with standard therapy, demonstrates that ILP and (131)I therapy approximately halves thyroid nodule volume within 6 months; but in contrast to (131)I, extranodular thyroid volume is unaffected by ILP and no patient developed...... hypothyroidism. Using the present design, ILP seems inferior to (131)I therapy in normalization of serum TSH. The potential value of ILP as a non-surgical alternative to (131)I needs further investigation...

  7. Clinical analysis of preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced non-small cell lung cancer

    Institute of Scientific and Technical Information of China (English)

    Qianping Li; Jianjun Wang; Jun Zhang; Chengyi Lin

    2012-01-01

    Objective: The purpose of this study was to assess the curative effect and adverse reaction of preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced non-small cell lung cancer (NSCLC). Methods: This prospective randomized controlled trial included 115 patients with locally advanced NSCLC were randomly divided into experimental and control groups and were treated from January 2007 to January 2010. The experimental group of 63 cases was treated with two cycles of induction chemotherapy before operation, radical surgery had been performed about three weeks after completion of chemotherapy, followed by received two cycles of chemotherapy. And the control group (52 cases) was treated at first with radical surgery, then treated with four cycles of chemotherapy. Two groups of the cases received routine thoracic radiotherapy with a total dose of 45 Gy. One cycle of gemcitabine combined with cisplatin regimen in-cluded gemcitabine 1000 mg/m2 on day 1 and day 8 and cisplatin 25 mg/m2 on day 1, day 2 and day 3 by intravenous infusion, with 21 days as one cycle. The tumor recurrence was evaluated by chest CT and abdominal B-ultrasound. Efficacy and toxicity results were compared by two groups. Results: All patients were followed up for three months to two years. The surgical stage of the experimental group reduced, two-years disease-free survival and postoperative recovery in the experimental group were better than in the control group, the difference was statistical significant. Toxicity and side effect after chemotherapy were mainly bone marrow suppression and gastrointestinal reactions, other complications included thrombocytopenia, leuko-penia, anemia, liver and kidney dysfunction were no significant difference in two groups. Conclusion: Preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced lung cancer can reduce the surgical staging and extend the postoperative disease-free survival.

  8. A Prospective Cluster-Randomized Trial of Telehealth Coaching to Promote Bone Health and Nutrition in Deployed Soldiers

    OpenAIRE

    McCarthy, Mary S.

    2014-01-01

    Findings from previous studies suggest that inadequate consumption of calcium and vitamin D and a decrease in exercise while deployed can be detrimental to bone health. This study enrolled 234 soldiers randomized to receive one-time nutrition and exercise education pre-deployment (n = 149), or telehealth coaching (n = 85), throughout the deployment cycle. Results suggest that online educational efforts may enhance sports activity, bone turnover, and vitamin D status. Improving vitamin D statu...

  9. The Effect of Aromatherapy Abdominal Massage on Alleviating Menstrual Pain in Nursing Students: A Prospective Randomized Cross-Over Study

    OpenAIRE

    Marzouk, Tyseer M. F.; El-Nemer, Amina M. R.; Baraka, Hany N.

    2013-01-01

    Dysmenorrhea is a common cause of sickness absenteeism from both classes and work. This study investigated the effect of aromatherapy massage on a group of nursing students who are suffering of primary dysmenorrhea. A randomized blind clinical trial of crossover design was used. In the first treatment phase, group 1 (n = 48) received aromatherapy abdominal massage once daily for seven days prior to menstruation using the essential oils (cinnamon, clove, rose, and lavender in a base of almond ...

  10. A Prospective Quasi-Randomized Comparison of Intraoperatively Built Custom-Linked Seeds Versus Loose Seeds for Prostate Brachytherapy

    International Nuclear Information System (INIS)

    Purpose: To compare dosimetric parameters, seed migration rates, operation times, and acute toxicities of intraoperatively built custom-linked (IBCL) seeds with those of loose seeds for prostate brachytherapy. Methods and Materials: Participants were 140 patients with low or intermediate prostate cancer prospectively allocated to an IBCL seed group (n=74) or a loose seed group (n=66), using quasirandomization (allocated by week of the month). All patients underwent prostate brachytherapy using an interactive plan technique. Computed tomography and plain radiography were performed the next day and 1 month after brachytherapy. The primary endpoint was detection of a 5% difference in dose to 90% of prostate volume on postimplant computed tomography 1 month after treatment. Seed migration was defined as a seed position >1 cm from the cluster of other seeds on radiography. A seed dropped into the seminal vesicle was also defined as a migrated seed. Results: Dosimetric parameters including the primary endpoint did not differ significantly between groups, but seed migration rate was significantly lower in the IBCL seed group (0%) than in the loose seed group (55%; P<.001). Mean operation time was slightly but significantly longer in the IBCL seed group (57 min) than in the loose seed group (50 min; P<.001). No significant differences in acute toxicities were seen between groups (median follow-up, 9 months). Conclusions: This prospective quasirandomized control trial showed no dosimetric differences between IBCL seed and loose seed groups. However, a strong trend toward decreased postimplant seed migration was shown in the IBCL seed group

  11. Survival benefit of hyperthermia in a prospective randomized trial of brachytherapy boost ± hyperthermia for glioblastoma multiforme

    International Nuclear Information System (INIS)

    Purpose: To determine if adjuvant interstitial hyperthermia (HT) significantly improves survival of patients with glioblastoma undergoing brachytherapy boost after conventional radiotherapy. Methods and Materials: Adults with newly-diagnosed, focal, supratentorial glioblastoma ≤ 5 cm in diameter were registered postoperatively on a Phase II/III randomized trial and treated with partial brain radiotherapy to 59.4 Gy with oral hydroxyurea. Those patients whose tumor was still implantable after teletherapy were randomized to brachytherapy boost (60 Gy at 0.40-0.60 Gy/h) ± HT for 30 min immediately before and after brachytherapy. Time to progression (TTP) and survival from date of diagnosis were estimated using the Kaplan-Meier method. Results: From 1990 to 1995, 112 eligible patients were entered in the trial. Patient ages ranged from 21-78 years (median, 54 years) and KPS ranged from 70-100 (median, 90). Most commonly due to tumor progression or patient refusal, 33 patients were never randomized. Of the patients, 39 were randomized to brachytherapy ('no heat') and 40 to brachytherapy + HT ('heat'). By intent to treat, TTP and survival were significantly longer for 'heat' than 'no heat' (p = 0.04 and p = 0.04). For the 33 'no heat' patients and 35 'heat' patients who underwent brachytherapy boost, TTP and survival were significantly longer for 'heat' than 'no heat' (p = 0.045 and p = 0.02, respectively; median survival 85 weeks vs. 76 weeks; 2-year survival 31% vs. 15%). A multivariate analysis for these 68 patients adjusting for age and KPS showed that improved survival was significantly associated with randomization to 'heat' (p = 0.008; hazard ratio 0.51). There were no Grade 5 toxicities, 2 Grade 4 toxicities (1 on each arm), and 7 Grade 3 toxicities (1 on 'no heat' and 6 on the 'heat' arm). Conclusion: Adjuvant interstitial brain HT, given before and after brachytherapy boost, after conventional radiotherapy significantly improves survival of patients with

  12. Intravenous 5-fluorouracil versus oral doxifluridine as preoperative concurrent chemoradiation for locally advanced rectal cancer. Prospective randomized trails

    International Nuclear Information System (INIS)

    Preoperative radiation treatment with concomitant intravenous infusion of 5-fluorouracil (5-FU) is known to be effective in shrinking and downstaging of tumors. However, chemotherapy has often been limited by its toxicity and poor patient compliance. Oral 5-FU is known to have several advantages over conventional intravenous 5-FU infusion such as lower toxicity and higher quality of life without compromising the efficacy of the treatment. The aim of this study was to compare intravenous 5-FU with oral doxifluridine with respect to tumor response, toxicity and quality of life. Twenty-eight patients with rectal cancer, staged as over T3N1 or T4 by transrectal ultrasonography between July 1997 and December 1998, were included in this study. Intravenous 5-FU (450 mg/m2) and leucovorin (20 mg/m2) were given for five consecutive days during the first and fifth weeks of radiation therapy (50.4 Gy) (n=14). Oral doxifluridine (700 mg/m2/day) and leucovorin (20 mg/m2) were given daily during radiation treatment (n=14). Quality of life was scored according to 22 activity items (good, >77; fair, >58; poor, <57). Surgical resection was performed 4 weeks after completion of concurrent chemoradiation treatment. Tumor response was classified into CR (complete remission), PR (partial response; 50% diminution of tumor volume or downstaging) and NR (no response). Tumor response was CR 3/14 (21.4%), PR 7/14 (50%) and NR 4/14 (28.6%) in the IV arm versus CR 2/14 (14.2%), PR 6/14 (42.9%) and NR 6/14 (42.9%) in the Oral arm (p=0.16, 0.23, 0.24), respectively. The quality of life was poor (36.4% versus 33.3%), fair and good (63.6% versus 66.7%) between the IV arm and Oral arm, respectively. Gastrointestinal toxicity was 2/14 (14.3%) in the IV arm versus 5/14 (35.7%) in the Oral arm, respectively. Stomatitis was only observed in the IV arm (1/14, 7.1%). Hematological toxicity was 3/14 (21.4%) in the IV arm versus 4/14 (28.5%) in the Oral arm, respectively. Systemic recurrence during the

  13. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial

    International Nuclear Information System (INIS)

    The MITO-2 (Multicentre Italian Trials in Ovarian cancer) study is a randomized phase III trial comparing carboplatin plus paclitaxel to carboplatin plus pegylated liposomal doxorubicin in first-line chemotherapy of patients with ovarian cancer. Due to the paucity of published phase I data on the 3-weekly experimental schedule used, an early safety analysis was planned. Patients with ovarian cancer (stage Ic-IV), aged < 75 years, ECOG performance status ≤ 2, were randomized to carboplatin AUC 5 plus paclitaxel 175 mg/m2, every 3 weeks or to carboplatin AUC 5 plus pegylated liposomal doxorubicin 30 mg/m2, every 3 weeks. Treatment was planned for 6 cycles. Toxicity was coded according to the NCI-CTC version 2.0. The pre-planned safety analysis was performed in July 2004. Data from the first 50 patients treated with carboplatin plus pegylated liposomal doxorubicin were evaluated. Median age was 60 years (range 34–75). Forty-three patients (86%) completed 6 cycles. Two thirds of the patients had at least one cycle delayed due to toxicity, but 63% of the cycles were administered on time. In most cases the reason for chemotherapy delay was neutropenia or other hematological toxicity. No delay due to palmar-plantar erythrodysesthesia (PPE) was recorded. No toxic death was recorded. Reported hematological toxicities were: grade (G) 3 anemia 16%, G3/G4 neutropenia 36% and 10% respectively, G3/4 thrombocytopenia 22% and 4% respectively. Non-haematological toxicity was infrequent: pulmonary G1 6%, heart rhythm G1 4%, liver toxicity G1 6%, G2 4% and G3 2%. Complete hair loss was reported in 6% of patients, and G1 neuropathy in 2%. PPE was recorded in 14% of the cases (G1 10%, G2 2%, G3 2%). This safety analysis shows that the adopted schedule of carboplatin plus pegylated liposomal doxorubicin given every 3 weeks is feasible as first line treatment in ovarian cancer patients, although 37% of the cycles were delayed due to haematological toxicity. Toxicities that are common

  14. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver

    Directory of Open Access Journals (Sweden)

    Biffi Roberto

    2012-05-01

    Full Text Available Abstract Background An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Methods Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel® Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel® Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. Results A total of 112 patients (58 in the experimental arm and 54 in the control group qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5% than in controls (14.3% center 1, 24.2% center 2, overall 20.4%, but the observed difference was not statistically significant (P = 0.451, even with respect to surgical-site infection grade 1 (superficial versus grades 2 and 3, or grade 1 and 2 versus grade 3. Conclusions This randomized trial did not confirm a statistically significant superiority of Aquacel® Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Trial registration Clinicaltrials.gov: NCT00981110

  15. Hemodialysis without systemic anticoagulation: a prospective randomized trial to evaluate 3 strategies in patients at risk of bleeding.

    Directory of Open Access Journals (Sweden)

    Bruno Guéry

    Full Text Available OBJECTIVE: In this clinical trial, we aimed to compare three means of performing chronic hemodialysis in patients with contra-indication to systemic heparinization. METHODS: This open-label monocentric randomized « n-of-one » trial, conducted in a single tertiary care center, recruited chronic hemodialysis patients with a contra-indication to systemic heparinization for at least 3 consecutive sessions. All patients underwent hemodialysis with an AN69ST dialyzer, and were administered three alternative dialysis procedures in a random sequence: intermittent saline flushes, constant saline infusion, or pre-dialysis heparin coating of the membrane. The primary outcome was the need to interrupt the dialysis session because of clotting events due to either (i a complete coagulation of the circuit; (ii a partial coagulation of the circuit; (iii a>50% rise over baseline in the venous pressure. RESULTS: At the end of the inclusion period (May, 2007 to December, 2008, the number of patients to include (n=75 was not reached: only 46 patients were included and underwent randomization. The study was terminated, and statistical analysis took into account 224 hemodialysis sessions performed in 44 patients with analyzable data. Heparin adsorption was associated with a significant reduction of the need to interrupt the dialysis session because of clotting events: odds ratio 0.3 (CI 95% 0.2 to 0.6; p3 h dialysis sessions and for having complete blood restitution. There were no significant effects of the dialysis procedure on weight loss, online ionic dialysance, and adverse events. CONCLUSION: Heparin-coated AN69ST dialysis membrane is a safe and effective method to avoid or delay per-dialytic clotting events in patients with contra-indication to systemic anticoagulation. However, results are not generalizable safely to patients with active bleeding, since weak heparinemia, not assessed in this study, may occur. TRIAL REGISTRATION: ClinicalTrials.gov NCT

  16. A Prospective Cluster-Randomized Trial of Telehealth Coaching to Promote Bone Health and Nutrition in Deployed Soldiers

    Directory of Open Access Journals (Sweden)

    Mary S. McCarthy

    2014-12-01

    Full Text Available Findings from previous studies suggest that inadequate consumption of calcium and vitamin D and a decrease in exercise while deployed can be detrimental to bone health. This study enrolled 234 soldiers randomized to receive one-time nutrition and exercise education pre-deployment (n = 149, or telehealth coaching (n = 85, throughout the deployment cycle. Results suggest that online educational efforts may enhance sports activity, bone turnover, and vitamin D status. Improving vitamin D status and remaining active while deployed appears to sustain healthy bone density in young soldiers. Early and aggressive educational outreach to young adults may prevent chronic musculoskeletal conditions and disabling osteoporosis later in life.

  17. Auricular Acupressure Reduces Anxiety Levels and Improves Outcomes of in Vitro Fertilization: A Prospective, Randomized and Controlled Study

    OpenAIRE

    Qu, Fan; Zhang, Dan; Chen, Lu-Ting; Wang, Fang-fang; Pan, Jie-Xue; Zhu, Yi-Min; Ma, Chun-Mei; Huang, Yi-Ting; Ye, Xiao-Qun; Sun, Sai-Jun; Zheng, Wen-Jun; Zhang, Run-Ju; Xu, Jian; Xing, Lan-Feng; Huang, He-Feng

    2014-01-01

    The study was to explore whether auricular acupressure (AA) can relieve anxiety during the period from trans-vaginal oocyte retrieval to the embryo transfer in IVF treatment and whether AA can improve the outcomes of IVF. 305 infertile patients with tubal blockage who were referred for IVF were included. The women were randomized into a control group with 102 cases, a Sham-AA group with 102 cases and an AA group with 101 cases. The anxiety levels were rated with Spielberger's State Trait Anxi...

  18. Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: a prospective, randomized, multicenter study

    OpenAIRE

    Tejani, Furqan H.; Thompson, Randall C.; Kristy, Rita; Bukofzer, Stan

    2014-01-01

    A multicenter, double-blind, randomized study was conducted to assess the effect of caffeine on regadenoson stress myocardial perfusion imaging (MPI). Subjects with a high likelihood of coronary artery disease underwent a rest single-photon emission computed tomography MPI on day 1 (MPI-1) and a stress MPI with regadenoson on day 3 (MPI-2). Individuals with ≥1 segment with a reversible defect received double-blind caffeine tablets (200 or 400 mg) or placebo 90 min before a repeat regadenoson ...

  19. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    International Nuclear Information System (INIS)

    Purpose: To investigate patients’ willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients’ stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients’ WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either “definitely” or “probably” participate. Seventeen percent (8 of 46) stated they would “definitely not” or “probably not” enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  20. Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

    Directory of Open Access Journals (Sweden)

    Duara Rajnish

    2008-01-01

    Full Text Available Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1 cases where residual pump blood was used and (2 controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1 st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained.

  1. Depressor and Anti-Inflammatory Effects of Angiotensin II Receptor Blockers in Metabolic and/or Hypertensive Patients With Coronary Artery Disease: A Randomized, Prospective Study (DIAMOND Study)

    Science.gov (United States)

    Adachi, Sen; Miura, Shin-ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro

    2016-01-01

    Background We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Methods Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Results Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. Conclusion In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD.

  2. Nutritional support of bone marrow transplant recipients: a prospective, randomized clinical trial comparing total parental nutrition to an enteral feeding program

    International Nuclear Information System (INIS)

    Allogeneic and autologous bone marrow transplantation (BMT) have been associated with nutritionally-depleting side effects. Total parental nutrition (TPN) has become the standard, but it has not been demonstrated that TPN is the appropriate method of nutritional support. Therefore, in a prospective, randomized clinical trial TPN and enteral feeding were compared for their effectiveness in maintaining the nutritional status of patients through the first 29 post-transplant days. Nutritional assessment included measurement of serum proteins, body weight, anthropometry and isotope dilution analysis of body composition. Total body water (TBW) and extracellular fluid (ECF) were quantified by standard radioisotope dilution techniques using tritiated water and 169ytterbium-diethylenetriaminepentaacetate, respectively as the tracers. Consenting patients 10-58 years of age were stratified by type of BMT (autologous or allogeneic) and randomized to either TPN plus ad libitum oral feeding or the individualized enteral feeding program (EFP), which included one-on-one counseling, meal-by-meal menu selection, special snacks and tube feeding. There were no differences in the rate of hematologic recovery, incidence of graft-versus-host disease, organ toxicity, length of hospitalization or survival. Therefore, the observed changes in body composition were not clinically significant. Even allowing for increased dietary service, the EFP was only half as expensive as TPN. It was concluded that TPN is not superior to the EFP and therefore, TPN should be reserved for patients who demonstrate intolerance to enteral feeding

  3. Nutritional support of bone marrow transplant recipients: a prospective, randomized clinical trial comparing total parental nutrition to an enteral feeding program

    Energy Technology Data Exchange (ETDEWEB)

    Szeluga, D.J.

    1985-01-01

    Allogeneic and autologous bone marrow transplantation (BMT) have been associated with nutritionally-depleting side effects. Total parental nutrition (TPN) has become the standard, but it has not been demonstrated that TPN is the appropriate method of nutritional support. Therefore, in a prospective, randomized clinical trial TPN and enteral feeding were compared for their effectiveness in maintaining the nutritional status of patients through the first 29 post-transplant days. Nutritional assessment included measurement of serum proteins, body weight, anthropometry and isotope dilution analysis of body composition. Total body water (TBW) and extracellular fluid (ECF) were quantified by standard radioisotope dilution techniques using tritiated water and /sup 169/ytterbium-diethylenetriaminepentaacetate, respectively as the tracers. Consenting patients 10-58 years of age were stratified by type of BMT (autologous or allogeneic) and randomized to either TPN plus ad libitum oral feeding or the individualized enteral feeding program (EFP), which included one-on-one counseling, meal-by-meal menu selection, special snacks and tube feeding. There were no differences in the rate of hematologic recovery, incidence of graft-versus-host disease, organ toxicity, length of hospitalization or survival. Therefore, the observed changes in body composition were not clinically significant. Even allowing for increased dietary service, the EFP was only half as expensive as TPN. It was concluded that TPN is not superior to the EFP and therefore, TPN should be reserved for patients who demonstrate intolerance to enteral feeding.

  4. Splenic irradiation before hematopoietic stem cell transplantation for chronic myeloid leukemia: long-term follow-up of a prospective randomized study.

    Science.gov (United States)

    Gratwohl, Alois; Iacobelli, Simona; Bootsman, Natalia; van Biezen, Anja; Baldomero, Helen; Arcese, William; Arnold, Renate; Bron, Dominique; Cordonnier, Catherine; Ernst, Peter; Ferrant, Augustin; Frassoni, Francesco; Gahrton, Gösta; Richard, Carlos; Kolb, Hans Jochem; Link, Hartmut; Niederwieser, Dietger; Ruutu, Tapani; Schattenberg, Anton; Schmitz, Norbert; Torres-Gomez, Antonio; Zwaan, Ferry; Apperley, Jane; Olavarria, Eduardo; Kröger, Nicolaus

    2016-05-01

    In the context of discussions on the reproducibility of clinical studies, we reanalyzed a prospective randomized study on the role of splenic irradiation as adjunct to the conditioning for hematopoietic stem cell transplantation (HSCT) for chronic myeloid leukemia (CML). Between 1986 and 1989, a total of 229 patients with CML were randomized; of these, 225 (98 %; 112 with, 113 without splenic irradiation) could be identified in the database and their survival updated. Results confirmed the early findings with no significant differences in all measured endpoints (overall survival at 25 years: 42.7 %, 32.0-52.4 % vs 52.9 %, 43.2-62.6 %; p = 0.355, log rank test). Additional splenic irradiation failed to reduce relapse incidence. It did not increase non-relapse mortality nor the risk of late secondary malignancies. Comforting are the long-term results from this predefined consecutive cohort of patients: more than 60 % were alive at plus 25 years when they were transplanted with a low European Society for Blood and Marrow Transplantation (EBMT) risk sore. This needs to be considered today when treatment options are discussed for patients who failed initial tyrosine kinase inhibitor therapy and have an available low risk HLA-identical donor. PMID:26994010

  5. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

    Directory of Open Access Journals (Sweden)

    Andrzej Kotela

    2015-01-01

    Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.

  6. A clinical examination of antibiotics in continuous regional arterial infusion (CRAI) therapy for severe acute pancreatitis (SAP). A prospective randomized controlled trial of BIPM and IPM/CS

    International Nuclear Information System (INIS)

    Continuous regional arterial infusion (CRAI) therapy using both protease inhibitors and antibiotics are one of the specific therapeutic methods for severe acute pancreatitis (SAP). As for the administered antibiotics, imipenem/cilastatin sodium (IPM/CS) is generally chosen as a first step, but there are only a few reports comparing IPM/CS with other antibiotics. Therefore, we performed a prospective randomized controlled trial between biapenem (BIPM) and IPM/CS as CRAI antibiotics. Twelve patients with SAP were admitted to our institution during April, 2009 since August, 2006, and were randomized into two groups. They were treated with 120 mg/day of nafamostat mesilate and either 1.2 g/day of BIPM (n=6) or 2.0 g/day of IPM/CS (n=6) for CRAI therapy within 48 hours after the administration. The clinical data, inflammatory markers (WBC, CRP), serum pancreatic enzymes (lipase, tripsin, phospholipase A2, elastase 1 and pancreatic secretory trypsin inhibitor (PSTI) and contrast-enhanced abdominal Computed Tomography findings were compared between the two groups and the adverse effects were monitored. CRAI therapy was performed for seven days. The curative effect of this therapy was evaluated at the beginning of the treatment, the day 7 and the day 14. Our results suggested that BIPM was a non-recessive antibiotic which had an equal effect in CRAI therapy in comparison with IPM/CS. (author)

  7. To determine block establishment time of supraclavicular brachial plexus block using blunt versus short bevel needle: A prospective randomized trial

    Directory of Open Access Journals (Sweden)

    V Ahuja

    2016-01-01

    Full Text Available Background: Unintentional intraneural injection under ultrasound guidance (USG with fine caliber needles and lower success rate with large caliber Tuohy needles in supraclavicular brachial plexus block (SCB have been reported. Materials and Methods: We undertook study to standardize the use of 20-gauge short versus blunt bevel needle for SCB. After approval of Institutional Ethics Committee and written informed consent, patients were randomized using computer-generated random number table to either of the two groups; blunt bevel needle group (n = 30: SCB under USG using 20-gauge Tuohy needle or short bevel needle group (n = 30: SCB under USG using 20-gauge short bevel needle. The primary outcome of the study was time to establishment of sensory and motor block of individual nerves, and secondary outcome was tolerability and any adverse effects. Results: The time to establishment of sensory and motor block in individual nerve territory was similar in both the groups. The complete sensory and motor anesthesia was achieved in 78.3% patients and complete sensory and motor anesthesia after supplementary block was achieved in 86.6% patients. Paresthesias during SCB were recorded in 15 patients. Out of these eight patients were of blunt bevel group and seven patients were of short bevel group. None of the patients experienced any neurological adverse effects. Conclusion: The establishment of sensory and motor blockade of individual nerves was similar to 20-gauge short and blunt bevel needle under ultrasound guide with no neurological adverse events.

  8. A prospective randomized trial of 4 Gy or 8 Gy single doses in the treatment of metastatic bone pain

    International Nuclear Information System (INIS)

    270 Patients with painful bone metastases requiring palliative radio -therapy were randomized to receive single fractions of 4 or 8 Gy in a randomized trial. Pain scores and analgesic usage were recorded before treatment and at 2, 4, 8 and 12 weeks. Pain was assessed by patients on a 4 point graded scale using pain charts administered by a central trials office. Response was defined as an improved rating compared to the pretreatment value. Compliance with the pain chart was 72% at 4 weeks. At 4 weeks, the actual response rates were 69% for 8 Gy and 44% for 4 Gy (p<0.001), but there was no difference in complete response (no pain) rates at 4 weeks or duration of response between the two arms. It is concluded that 8 Gy gives a higher probability of pain relief than 4 Gy, but that 4 Gy can be an effective alternative in situations of reduced tolerance. (author). 6 refs.; 4 figs.; 5 tabs

  9. Hemodynamic Consequences of Malignant Ascites in Epithelial Ovarian Cancer Surgery*: A Prospective Substudy of a Randomized Controlled Trial.

    Science.gov (United States)

    Hunsicker, Oliver; Fotopoulou, Christina; Pietzner, Klaus; Koch, Mandy; Krannich, Alexander; Sehouli, Jalid; Spies, Claudia; Feldheiser, Aarne

    2015-12-01

    Malignant ascites (MA) is most commonly observed in patients scheduled for epithelial ovarian cancer (EOC) surgery and is supposed as a major risk factor promoting perioperative hemodynamic deterioration. We aimed to assess the hemodynamic consequences of MA on systemic circulation in patients undergoing cytoreductive EOC surgery.This study is a predefined post-hoc analysis of a randomized controlled pilot trial comparing intravenous solutions within a goal-directed algorithm to optimize hemodynamic therapy in patients undergoing cytoreductive EOC surgery. Ascites was used to stratify the EOC patients prior to randomization in the main study. We analyzed 2 groups according to the amount of ascites (NLAS: none or low ascites [500 mL]). Differences in hemodynamic variables with respect to time were analyzed using nonparametric analysis for longitudinal data and multivariate generalized estimating equation adjusting the analysis for the randomized study groups of the main study.A total of 31 patients in the NLAS and 16 patients in the HAS group were analyzed. Although cardiac output was not different between groups suggesting a similar circulatory blood flow, the HAS group revealed higher heart rates and lower stroke volumes during surgery. There were no differences in pressure-based hemodynamic variables. In the HAS group, fluid demands, reflected by the time to reindication of a fluid challenge after preload optimization, increased steadily, whereas stroke volume could not be maintained at baseline resulting in hemodynamic instability after 1.5 h of surgery. In contrast, in the NLAS group fluid demands were stable and stroke volume could be maintained during surgery. Clinically relevant associations of the type of fluid replacement with hemodynamic consequences were particularly observed in the HAS group, in which transfusion of fresh frozen plasma (FFP) was associated to an improved circulatory flow and reduced vasopressor and fluid demands, whereas the

  10. B-IGEV (bortezomib plus IGEV) versus IGEV before high-dose chemotherapy followed by autologous stem cell transplantation in relapsed or refractory Hodgkin lymphoma: a randomized, phase II trial of the Fondazione Italiana Linfomi (FIL).

    Science.gov (United States)

    Balzarotti, Monica; Brusamolino, Ercole; Angelucci, Emanuele; Carella, Angelo Michele; Vitolo, Umberto; Russo, Eleonora; Congiu, Angelagiovanna; Gotti, Manuel; Massidda, Stefania; Botto, Barbara; Annechini, Giorgia; Spina, Michele; Re, Alessandro; Zilioli, Vittorio Ruggero; Merli, Francesco; Salvi, Flavia; Stelitano, Caterina; Bonfichi, Maurizio; Rodari, Marcello; Murru, Roberta; Magagnoli, Massimo; Anastasia, Antonella; Mazza, Rita; Giordano, Laura; Santoro, Armando

    2016-10-01

    This randomized, multicenter study evaluates the addition of bortezomib (13 mg/m(2)) to IGEV (B-IGEV) in patients with relapsed/refractory Hodgkin Lymphoma (HL). Patients received either four courses of IGEV alone (n = 40) or B-IGEV (n = 40). The primary endpoint was the complete response (CR) proportion, evaluated by FDG-PET, after induction chemotherapy. CR proportion was 39% with B-IGEV and 53% with IGEV. PFS and OS were similar between the two groups (two-year PFS: 58% vs 56%; two-year OS: 93% vs 81%). The PET-negative status after treatment was the only variable favorably influencing both PFS (two-year PFS: 77% vs 40%; p = 0.002) and OS (two-year OS: 100% vs 76%; p < 0.001). Toxicity was overall similar with the two regimens. The addition of bortezomib to IGEV does not improve response in relapsed/refractory HL patients. However, its favorable therapeutic and safety profile, and the prognostic role of pre-transplant PET negativity in patients receiving IGEV-based regimens are confirmed. PMID:26879066

  11. Comparison of 1470 nm Laser and Radial 2ring Fiber with 980 nm Laser and Bare-Tip Fiber in Endovenous Laser Ablation of Saphenous Varicose Veins: A Multicenter, Prospective, Randomized, Non-Blind Study

    OpenAIRE

    Hirokawa, Masayuki; Ogawa, Tomohiro; Sugawara, Hiromitsu; Shokoku, Shintaro; Sato, Shoji

    2015-01-01

    Objective: The aim of this study is to compare the clinical efficacy and safety of two laser wavelengths and fiber types in endovenous laser ablation (EVLA) of saphenous varicose veins of the lower limb. Design: Multi-center prospective randomized non-blind clinical trial.

  12. Efficacy of the natural antioxidant astaxanthin in the treatment of functional dyspepsia in patients with or without Helicobacter pylori infection: a prospective, randomized, double blind, and placebo-controlled study5

    DEFF Research Database (Denmark)

    Kupcinskas, L.; Lafolie, P.; Lignell, A.;

    2008-01-01

    OBJECTIVES: The aim of this study was to evaluate the efficacy of the natural antioxidant astaxanthin in functional dyspepsia in different doses and compared with placebo. DESIGN: The study was a controlled, prospective, randomized, and double blind trial. PARTICIPANTS: Patients with functional d...