Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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