Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Suzanna M Zick, ND, MPH
University of Michigan
United States: Federal Government
|St. Joseph Mercy Hospital||Pontiac, Michigan 48341-2985|
|Our Lady of Mercy Medical Center, Comprehensive Cancer Center||Bronx, New York 10466|
|Northern Indiana Cancer Research Consortium CCOP||South Bend, Indiana|
|University of Michigan Cancer Center Complementary and Alternative Medicine Research Center||Ann Arbor, Michigan 48104|
|Community Clinic Oncology Program||Grand Rapids, Michigan 49503|