Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Treatment of Delayed Nausea: What Works Best?
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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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