Prophylactic tropisetron versus rescue tropisetron in fractionated radiotherapy to moderate or high emetogenic areas: a prospective randomized open label study in cancer patients.

AIM: A prospective randomized open label study was carried out to evaluate the efficacy and effectiveness of prophylactic tropisetron versus rescue tropisetron in fractionated radiotherapy. PATIENTS AND METHODS: The study sample consisted of 288 cancer patients randomly allocated (3:4 ratio) into two treatment groups: 120 patients received prophylactic antiemetic treatment with tropisetron and 168 patients received rescue tropisetron. To determine the efficacy of prophylactic antiemetic treatment, nausea and vomiting were evaluated 1 d before radiation therapy (RT), at 24 and 72 h, at the end of every week during RT, and finally 1 wk after RT. Diary cards were used to record the intensity of nausea and vomiting as well as the incidence of adverse effects.
RESULTS: In the odds of nausea and vomiting, statistically significant differences were found between the two treatment groups over time. The incidence of nausea and vomiting were 1.89 (p = 0.009) and 2.19 (p = 0.001) times higher in the rescue tropisetron group than in the prophylactic tropisetron group. Factors that related significantly with increased nausea were primary cancer, rescue tropisetron, and radical RT. Moreover, factors for vomiting were primary cancer type, metastasis, palliative RT, and rescue tropisetron.
CONCLUSIONS: Higher numbers of patients receiving prophylactic tropisetron completed RT with lower incidence of nausea and vomiting than those in the rescue tropisetron group.

RCT Entities:   Population Interventions Outcomes