Conditions: Nausea and Vomiting, Chemotherapy-Induced
Keywords: vomiting colorectal cancer nausea oxaliplatin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 710
Healthy volunteers: no

Brief summary:
This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.

Detailed description:

Arms:
arm 1: Placebo + standard antiemetics arm 2: Casopitant + standard antiemetics

Interventions: intervention 1: Casopitant intervention 2: Dexamethasone intervention 3: Placebo intervention 4: Ondansetron
Intervention descriptions: intervention 1: Experimental NK-1 receptor antagonist intervention 2: Standard antiemetics intervention 3: Placebo to match IV casopitant intervention 4: Standard antiemetics

Protocol document: