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RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy.
PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer.
- Compare the efficacy of 1 course of ginger vs placebo when administered in regimens containing a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic and dexamethasone (or the equivalent dose of IV methylprednisolone) in controlling chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer.
- Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients.
- Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients.
- Determine the adverse effects of these antiemetic regimens during the 4 days after chemotherapy.
- Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens.
- Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens.
- Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms. Day 1 of each course is defined as the day of chemotherapy administration.
- Arm I: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
- Arm II: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
- Arm III: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
- Arm IV: Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a 5-hydroxytryptamine type-3 (5-HT3) receptor antagonist (ondansetron, granisetron, tropisetron, and dolasetron mesylate) and dexamethasone (DM) (or the equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of courses 2 and 3.
Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3.
Quality of life is assessed on day 4 of courses 1-3.
Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3.
PROJECTED ACCRUAL: A total of 706 patients will be accrued for this study within 3 years.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care
Nausea and Vomiting
ginger extract, placebo
MBCCOP - Gulf Coast
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:59-0400
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