A RANDOMIZED PLACEBO-CONTROLLED STUDY WITH ONDANSETRON IN PATIENTS UNDERGOING FRACTIONATED RADIOTHERAPY

Background: There are few randomised studies comparing anti-emetic dru gs for the prevention of nausea and vomiting in patients treated with fractionated radiotherapy. The aim of the study was to compare the ant i-emetic efficacy of 8 mg dose ondansetron twice a day with placebo. M aterials and methods: One hundred eleven patients who were to commence a course of 10 or more daily fractionated radiotherapy including the abdomen were included in the study. The patients recorded daily emesis , nausea and bowel habit and graded weekly symptoms of nausea, vomitin g, diarrhoea and lack of appetite. The EORTC C30 questionnaire was com pleted. Results: 67% of patients given ondansetron had complete contro l of emesis compared with 45% of patients with placebo (P < 0.05). The number of emetic episodes recorded on the worst day was 1.4 for the o ndansetron group and 3.1 for the placebo group (P < 0.01). Patients gi ven ondansetron had fewer days with emesis and nausea compared with pl acebo (P < 0.05). The mean sum score of patients weekly grading of sym ptoms showed that the ondansetron group had less inconvenience than th e placebo group (P < 0.05). This difference persisted during the first three weeks, but not thereafter. Similarly, some quality of life meas ures showed significant differences in favour of the ondansetron group . More patients (n = 13) withdrew due to lack of efficacy in the place bo group compared with patients (n = 8) in the ondansetron group. Conc lusions: The present study illustrates that prophylactic anti-emetic a dministration of ondansetron is effective in preventing nausea and vom iting in patients undergoing fractionated radiotherapy of the abdomen.