NCT00003213

Drugs to Reduce the Side Effects of Chemotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy.

Detailed description

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.

Conditions

• Nausea and Vomiting
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	dexamethasone	4 mg Dexamethasone in the morning
DRUG	granisetron hydrochloride	1 mg Granisetron in the morning
DRUG	metoclopramide hydrochloride	20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening)

Timeline

• Start date: 1996-05-01
• Primary completion: 1999-04-01
• Completion: 1999-08-01
• First posted: 2004-08-02
• Last updated: 2012-07-11

Locations

10 sites across 2 countries: Italy, Switzerland