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Ginger Control of Chemotherapy Induced Nausea and Vomiting
Verified by National Center for Complementary and Alternative Medicine (NCCAM) August 2006
Purpose
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
|
MedlinePlus related topics: Nausea and Vomiting
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
Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):
Expected Total Enrollment: 180
Study start: June 2003
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
- Confirmed diagnosis of cancer and currently receiving chemotherapy
- Currently being treated with any chemotherapeutic agent at any dose, and have experienced nausea and/or vomiting from a previous round of chemothearpy
- Scheduled to receive a 5-HT3 receptor antagonist antiemetic: ondansetron (Zofran®) granistron (Kytril®), tropisetron (Navoban®) or dolasetron mesylate (Anzemet®), palanosetron (Alozi) and/or the NK1 antagonist aprepitant (Emend)
- Must be able to swallow capsules
- Must be able to understand English or Spanish, complete questionnaires in English or Spanish
- Women of childbearing age to use appropriate birth control
Exclusion criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00065221
Indiana
Northern Indiana Cancer Research Consortium CCOP, South Bend, Indiana, United States; Not yet recruiting
Michigan
St. Joseph Mercy Hospital, Ann Arbor, Michigan, 48106, United States; Recruiting
Community Clinic Oncology Program, Grand Rapids, Michigan, 49503, United States; Recruiting
University of Michigan Cancer Center Complementary and Alternative Medicine Research Center, Ann Arbor, Michigan, 48104, United States; Recruiting
New York
Our Lady of Mercy Medical Center, Comprehensive Cancer Center, Bronx, New York, 10466, United States; Recruiting
Puerto Rico
Community Clinic Oncology Program, San Juan, Puerto Rico; Not yet recruiting
Doris Cuadrado 787-758-7575 Ext. 10149
Study chairs or principal investigators
Suzanna M Zick, ND, MPH, Principal Investigator, University of Michigan
More Information
Study ID Numbers: R21 AT001735-01
Last Updated: August 16, 2006
Record first received: July 18, 2003
ClinicalTrials.gov Identifier:
NCT00065221
Health Authority: United States: Food and Drug Administration
 
