UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (IRB 2003-551)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00064272|
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : October 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific||Drug: ginger extract Other: placebo||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||May 2007|
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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|