Treatment of Delayed Nausea: What Works Best?
- 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
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.
Allocation: Randomized, Primary Purpose: Supportive Care
Gary R. Morrow, PhD, MS
James P. Wilmot Cancer Center
United States: Federal Government
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Greenville||Greenville, South Carolina 29615|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|MBCCOP - Gulf Coast||Mobile, Alabama 36688|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|CCOP - Colorado Cancer Research Program, Incorporated||Denver, Colorado 80224|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|