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Brief Title: Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
Official Title: Treatment of Delayed Nausea: What Works Best?
Study ID: NCT00020657
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
MBCCOP - Gulf Coast, Mobile, Alabama, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
CCOP - Columbus, Columbus, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Northwest, Tacoma, Washington, United States
Name: Gary R. Morrow, PhD, MS
Affiliation: James P. Wilmot Cancer Center
Role: STUDY_CHAIR