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Sponsors and Collaborators: |
University of Michigan Cancer Center National Cancer Institute (NCI) National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064272 |
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 | Intervention | Phase |
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Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ginger extract Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting |
Estimated Enrollment: | 180 |
Study Start Date: | May 2003 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive lower-dose oral ginger twice daily.
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Drug: ginger extract
Given orally
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Arm II: Experimental
Patients receive higher-dose oral ginger twice daily.
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Drug: ginger extract
Given orally
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Arm III: Placebo Comparator
Patients receive oral placebo twice daily.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
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).
Patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)
Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:
Surgery
Other
No other concurrent ginger (teas, capsules, tinctures)
No concurrent therapeutic-doses of warfarin, aspirin, or heparin
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
United States, Michigan | |
CCOP - Grand Rapids | |
Grand Rapids, Michigan, United States, 49503 | |
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 | |
United States, New York | |
MBCCOP - Our Lady of Mercy Cancer Center | |
Bronx, New York, United States, 10466 | |
Puerto Rico | |
MBCCOP - San Juan | |
San Juan, Puerto Rico, 00936 |
Study Chair: | Suzanna Zick, MPH, ND | University of Michigan Cancer Center |
Study ID Numbers: | CDR0000310163, CCUM-0201 |
Study First Received: | July 8, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00064272 |
Health Authority: | United States: Federal Government |
nausea and vomiting unspecified adult solid tumor, protocol specific |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Nausea |