A Randomized, Double-Blind Trial to Compare the Clinical Efficacy and Safety of Granisetron vs. Metoclopramide Combined to Dexamethasone in the Prophylaxis of Chemotherapy-Induced Delayed Emesis
OBJECTIVES: I. Compare the clinical efficacy and safety of Granisetron or Metoclopramide in
combination with Dexamethasone in the prophylaxis of delayed nausea and vomiting induced by
emetogenic cancer chemotherapy in patients with or without emesis in the acute phase.
OUTLINE: This is a randomized, double blind study. Patients are stratified by prior
chemotherapy (yes vs no), regular alcohol consumption (yes vs no), and prior chemotherapy
regimen (cisplatin/carboplatin vs others). Patients receive dexamethasone and granisetron by
mouth bid on day 0. Patients are then randomized to receive either granisetron or
metoclopramide with dexamethasone concurrently with chemotherapy. Arm I: Patients receive
granisetron by mouth bid on days 1-5. Dexamethasone and a placebo are administered by mouth
once daily on days 1-5. Arm II: Patients receive metoclopramide by mouth tid on days 1-5.
Dexamethasone is administered by mouth once daily on days 1-5. Patients must complete a
diary card daily for 6 days.
PROJECTED ACCRUAL: This study will accrue 360 patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
Complete and partial control of emesis
Total control of emesis on every one of the 5 days following the acute phase
Matti S. Aapro, MD
European Institute of Oncology