Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
- 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
- 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
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Most efficacious dose
Suzanna Zick, MPH, ND
University of Michigan Cancer Center
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|University of Michigan Cancer Center CCOP Research Base||Ann Arbor, Michigan 48109-0725|
|MBCCOP - Our Lady of Mercy Cancer Center||Bronx, New York 10466|