NCT00020657

Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer

Treatment of Delayed Nausea: What Works Best?

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Gary Morrow · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy. PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.

Detailed description

OBJECTIVES: * Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer. * Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients. * Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine. * Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1. Patients are then randomized to 1 of 3 antiemetic arms. * Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3. * Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12 hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3. * Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on days 2 and 3. Quality of life is assessed at baseline and on day 4. PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.

Conditions

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

Interventions

Type	Name	Description
DRUG	dolasetron mesylate
DRUG	granisetron hydrochloride
DRUG	ondansetron
DRUG	prochlorperazine
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2001-07-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2003-01-27
• Last updated: 2015-10-15

Locations

15 sites across 1 country: United States