European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Therapeutic equivalence of single oral doses of dolasetron mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy. European Dolasetron Comparative Study Group.
This multicentre, randomised, double-blind study was designed to compare the anti-emetic efficacy and safety of single oral doses of dolasetron mesilate with that of the approved oral, multiple-dose regimen of ondansetron in 399 cancer patients receiving moderately emetogenic chemotherapy. Single oral doses of 25, 50, 100 or 200 mg of dolasetron mesilate were administered 1 h prior to the initiation of moderately emetogenic chemotherapy. Multiple doses of ondansetron (8 mg x 3 or 8 mg x 4) capsules, or matching placebo for patients randomised to dolasetron, were given 1.5 h before and 6.5, 14.5 and 22.5 h after the start of chemotherapy (total dose = 32 mg). ⋯ Headache was most frequently reported (approximately 15% for each drug). No clinically important changes in vital signs or clinical laboratory parameters were observed with either drug. In conclusion, a single oral 200 mg dolasetron mesilate dose was therapeutically equivalent to multiple-dose ondansetron in the prevention of emesis and nausea following moderately emetogenic chemotherapy.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A double-blind, randomised comparison of the anti-emetic efficacy of two intravenous doses of dolasetron mesilate and granisetron in patients receiving high dose cisplatin chemotherapy.
This multicentre, double-blind, double-dummy, randomised trial was designed to compare the efficacy and safety of single intravenous doses of dolasetron mesilate and granisetron in the prevention of acute emesis and nausea due to high-dose (> or = 80 mg/m2) cisplatin. Single intravenous doses of 1.8 or 2.4 mg/kg of dolasetron mesilate or 3 mg of granisetron hydrochloride were administered in a volume of 50 ml over a 5-min period, beginning 30 min prior to cisplatin (> or = 80 mg/m2) administration. The number and timing of emetic episodes, time to administration of escape anti-emetic medication, severity of nausea by visual analogue scale (VAS), and safety were monitored for 24 h after the start of cisplatin-containing chemotherapy. ⋯ The overall incidences of adverse events were comparable among the treatment groups; headache and diarrhoea were most common. In conclusion, 1.8 and 2.4 mg/kg of dolasetron mesilate and granisetron (3 mg) were equally effective in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, because no additional benefit was observed with 2.4 mg/kg of dolasetron mesilate and numerically greater responses were observed with the 1.8 mg/kg dose, the lower dose of 1.8 mg/kg is optimal for further clinical development.
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Multicenter Study
Spiritual healing among Norwegian hospitalised cancer patients and patients' religious needs and preferences of pastoral services.
In a national questionnaire-based multicentre study, the use of 'alternative medicine', here called non-proven therapy (NPT), was examined. Five questions about the patients' religious beliefs and their preferences concerning pastoral services in the hospitals were included. Among the 911 invited patients, 642 (70.5%) were included in the analysis. ⋯ Women, elderly people and patients using faith healing described themselves more often as religious. 139 (23%) of the responding patients reported a strengthening of their religious belief after the diagnosis of cancer. Patients less than 45 years of age and better educated patients expressed more frequently that all patients should be offered pastoral services during the hospital stay. Older patients, in spite of being more religious, expressed that the patients themselves had to request such services.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The effect of blood transfusions on survival after surgery for colorectal cancer.
The immunosuppressive effect of allogeneic blood transfusions can be associated with a poor prognosis for cancer patients. Predeposit autologous blood transfusions could be a solution to overcome this putative deleterious effect. We performed a randomised clinical study to compare the effects of autologous with allogeneic blood transfusions in colorectal cancer patients. ⋯ This association of transfusions with recurrent disease was only the case for local recurrences, whereas the incidence of distant metastases was unaffected. We conclude that the use of a predeposit autologous blood transfusion programme does not improve the prognosis in colorectal cancer patients. The negative association between blood transfusions and cancer recurrence is only true for local recurrences, which suggests that not the blood transfusions themselves but rather the circumstances necessitating them are the real predictors of prognosis.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Oral ondansetron in the prevention of chemotherapy-induced emesis in breast cancer patients. French Ondansetron Study Group.
A multicentre randomised, double-blind parallel group study has been carried out in order to confirm the antiemetic efficacy of orally administered ondansetron. A total of 259 chemotherapy-naive breast cancer patients treated with a 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) or 5-fluorouracil, epirubicin, cyclophosphamide (FEC) regimen were randomly assigned to ondansetron (OND) 8 mg tablet or alizapride (ALI) 150 mg intravenous (i.v.) injection, prior to chemotherapy. These treatments were then followed by OND 8 mg tablet or ALI 50 mg tablet, respectively, 8 to 12 h later. ⋯ In terms of quality of life in relation to emesis phenomena, OND was significantly superior to ALI (P = 0.04). Both treatments were well tolerated. In the prevention of the prolonged emesis induced by FAC/FEC-type emetogenic chemotherapy, orally administered OND was superior to ALI, given as an i.v. injection and followed by tablets.