UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (IRB 2003-551)
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.
|Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific||Drug: ginger extract Other: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213|
- Most efficacious dose
- Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)
|Study Start Date:||May 2003|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive lower-dose oral ginger twice daily.
Drug: ginger extract
Experimental: Arm II
Patients receive higher-dose oral ginger twice daily.
Drug: ginger extract
Placebo Comparator: Arm III
Patients receive oral placebo twice daily.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064272
|United States, Indiana|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Michigan|
|University of Michigan Cancer Center CCOP Research Base|
|Ann Arbor, Michigan, United States, 48109-0725|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|United States, New York|
|MBCCOP - Our Lady of Mercy Cancer Center|
|Bronx, New York, United States, 10466|
|MBCCOP - San Juan|
|San Juan, Puerto Rico, 00936|
|Study Chair:||Suzanna Zick, MPH, ND||University of Michigan Cancer Center|