Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00020657|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific||Drug: dolasetron mesylate Drug: granisetron hydrochloride Drug: ondansetron Drug: prochlorperazine Procedure: quality-of-life assessment||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|Official Title:||Treatment of Delayed Nausea: What Works Best?|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||October 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020657
|United States, Alabama|
|MBCCOP - Gulf Coast|
|Mobile, Alabama, United States, 36688|
|United States, Arizona|
|CCOP - Western Regional, Arizona|
|Phoenix, Arizona, United States, 85006-2726|
|CCOP - Mayo Clinic Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Colorado|
|CCOP - Colorado Cancer Research Program, Incorporated|
|Denver, Colorado, United States, 80224|
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, New Jersey|
|CCOP - Northern New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|CCOP - North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Winston-Salem, North Carolina, United States, 27104-4241|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43206|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|United States, Washington|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|Study Chair:||Gary R. Morrow, PhD, MS||James P. Wilmot Cancer Center|