Phase II clinical trial of palonosetron combined with tropisetron in preventing chemotherapy-induced nausea and vomiting.

The purpose of the study was to evaluate the efficacy and toxicity of palonosetron combined with tropisetron in preventing chemotherapy-induced nausea and vomiting. A total of 82 non-small cell lung cancer patients undergoing Docetaxel combined with Cisplatin were randomly divided into group A and group B. The patients were received palonosetron combined with tropisetron (group A, n = 42) or tropisetron alone (group B, n = 40) before initiation of chemotherapy. The nausea degree, antiemetic efficacy and safety after chemotherapy were evaluated. Patients were administered for rescue therapy if needed. Results showed no significant difference in complete remission rate (CRR) during acute phase (0-24 h post chemotherapy) between group A and group B (90.48% versus 75%, P > 0.05). The CRR of group A during delayed (24-120 h post chemotherapy) and overall phases (0-120 h post chemotherapy) were 83.33% and 78.57%, higher than group B (50% and 42.50%, P < 0.05). AS for the improvement rate of nausea during delayed phase, group A is better than group B (57.14% versus 35%, P < 0.05). The adverse drug reactions of two groups were mild and generally well tolerated, including headache, constipation and abdominal distension, and no statistically significant differences were observed. In conclusions, compared to tropisetron alone, the therapy of palonosetron plus tropisetron is more effective and safer in controlling of nausea and vomiting induced by high emetic risk chemotherapy.

RCT Entities:   Population Interventions Outcomes