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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00065221 |
This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and severity of chemotherapy induced nausea and vomiting.
Condition | Intervention | Phase |
---|---|---|
Nausea Vomiting Chemotherapy |
Drug: Ginger |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting |
Estimated Enrollment: | 180 |
Study Start Date: | June 2003 |
Study Completion Date: | January 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Chemotherapy induced nausea and vomiting significantly reduces patients' quality of life, increases fatigue, anxiety, and increases costs of health care delivery. Ginger (Zingiber officinalis) is already used in traditional folk medicine to treat nausea and vomiting in various populations. Ginger's ability to block 5-HT3 receptors and its free-radical scavenging in the intestines suggest that it may be beneficial for reducing both the prevalence and severity of chemotherapy induced nausea and vomiting. Despite ginger's possible benefits in reducing the prevalence and severity of chemotherapy induced nausea and vomiting, no dosing and/or safety studies have been performed.
This study will assess the efficacy and safety of two dose levels (1000 mg, or 2000 mg, orally/day) of Zingiber officinalis extract (standardized for 5% gingerols) in patients undergoing chemotherapy (cisplastin or adriamycin) who have experienced at least one episode of chemotherapy induced nausea and vomiting despite optimal conventional medical therapy. The primary aim of the study is to determine the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of acute nausea and vomiting. Secondary aims of the study include (1) determination of the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of delayed nausea and vomiting; (2) assessment of the safety of different doses of oral powdered ginger root in patients receiving chemotherapy; and (3) determination if study participants can discern if they are receiving placebo or ginger. Participants receiving either adriamycin or cisplatin for cancer related treatment will be randomized to receive one of two doses of powdered ginger or placebo immediately prior to chemotherapy infusion. Participants will be followed for 72 hours after infusion in order to assess frequency and severity of nausea and vomiting. Baseline and 72 hour post chemotherapy labs will be used to assess safety profile of ginger.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Clinical evidence of current or impending bowel obstruction or symptomatic brain metastases
United States, Indiana | |
Northern Indiana Cancer Research Consortium CCOP | |
South Bend, Indiana, United States | |
United States, Michigan | |
St. Joseph Mercy Hospital | |
Ann Arbor, Michigan, United States, 48106 | |
Community Clinic Oncology Program | |
Grand Rapids, Michigan, United States, 49503 | |
University of Michigan Cancer Center Complementary and Alternative Medicine Research Center | |
Ann Arbor, Michigan, United States, 48104 | |
United States, New York | |
Our Lady of Mercy Medical Center, Comprehensive Cancer Center | |
Bronx, New York, United States, 10466 | |
Puerto Rico | |
Community Clinic Oncology Program | |
San Juan, Puerto Rico |
Principal Investigator: | Suzanna M Zick, ND, MPH | University of Michigan |
Study ID Numbers: | R21 AT001735-01 |
Study First Received: | July 18, 2003 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00065221 |
Health Authority: | United States: Federal Government |
Ginger Plant preparation Herbal medicine Chemotherapy Nausea |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Nausea |