Spots Global Cancer Trial Database for UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

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Trial Identification

Brief Title: UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

Official Title: Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213

Study ID: NCT00064272

Conditions

Nausea and Vomiting

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

ginger extract

placebo

Study Description

Brief Summary: RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer. PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

Detailed Description: OBJECTIVES: Primary * Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo. Secondary * Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens. * Compare the safety of these regimens in these patients. * Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting). OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist). * Arm I: Patients receive lower-dose oral ginger twice daily. * Arm II: Patients receive higher-dose oral ginger twice daily. * Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days. Patients are followed at 1 week. PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.