Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
- Conditions
- Nausea and VomitingUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00020657
- Lead Sponsor
- Gary Morrow
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States