Ginger Control of Chemotherapy Induced Nausea and Vomiting

2014-08-27 03:55:05 | BioPortfolio


This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and severity of 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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment






Northern Indiana Cancer Research Consortium CCOP
South Bend
United States




National Center for Complementary and Alternative Medicine (NCCAM)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:55:05-0400

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Medical and Biotech [MESH] Definitions

A drug combination that contains DIPHENHYDRAMINE and THEOPHYLLINE. It is used for treating vertigo, motion sickness, and nausea associated with pregnancy. It is not effective in the treatment of nausea associated with cancer chemotherapy.

Deciduous plant rich in volatile oil (OILS, VOLATILE). It is used as a flavoring agent and has many other uses both internally and topically.

A plant family of the order Zingiberales, subclass Zingiberidae, class Liliopsida. It includes plants which have both flavoring and medicinal properties such as GINGER; turmeric (CURCUMA), and cardamom (ELETTARIA).

This plant order includes 8 families, 66 genera, and about 1,800 species. These herbaceous perennials are mainly found in the wet tropics. Members include the banana family (MUSACEAE) and GINGER family (ZINGIBERACEAE).

Emesis and queasiness occurring after anesthesia.

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