Randomized double-blind, placebo-controlled evaluation of oral ondansetron in the prevention of nausea and vomiting associated with fractionated total-body irradiation.

Abstract

Oral ondansetron is an effective therapy for the prevention of emesis induced by TBI.

Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation

“…22 The comparability of the results validate this study design and emphasize the significance of the findings regarding the efficacy of oral granisetron. The results of the first study show that 30% of ondansetron-treated patients experienced no vomiting episodes, whereas the results of the current study show that 26.7% of ondansetron-treated patients experienced complete emetic control.…”

“…This allowed for doubleblinding, and created a basis for comparing the results of this study with those of a previous placebo-controlled study using the same TBI regimen to determine the efficacy of ondansetron, although it did not allow for a 'head-to-head' comparison of granisetron and ondansetron. 22 The safety of granisetron and ondansetron was demonstrated in this study. The most frequently reported adverse event in both treatment groups was headache.…”

“…22 None of the patients in either the historical control group or the placebo group from the two studies had complete emetic control over the 4-day study period. All of the patients who received placebo or were in the historical control group required rescue antiemetic medication.…”

“…12,13,22,34 A trial of adequate statistical power (90%) to compare granisetron with ondansetron would require such a large patient population (at least 500 patients) that recruitment of patients and ensuring that a standardized regimen of TBI would continue to be used prior to the administration of conditioning chemotherapy would be difficult.…”

“…Ondansetron administered orally has been shown to be effective for the prophylaxis of TBI-induced nausea and vomiting, but no studies have assessed the efficacy of oral granisetron in adult patients for this purpose. 22 This randomized, double-blind, double-dummy trial was designed to assess the efficacy and safety of two 5-HT 3 -receptor antagonists, granisetron and ondansetron, when administered orally for the prevention of nausea and vomiting in patients receiving TBI prior to BMT compared with a prospectively defined historical negative control group composed of patients who did not receive 5-HT 3 -receptor antagonist antiemetic therapy.…”