Ginger Control of Chemotherapy Induced Nausea and Vomiting

Phase 2

Completed

• Conditions: Nausea; Vomiting; Chemotherapy

• Registration Number: NCT00065221
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-07-18
• Study First Submitted QC: 2003-07-21
• Study First Posted: 2003-07-22
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-24
• Last Update Posted: 2008-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (5)

Northern Indiana Cancer Research Consortium CCOP; 🇺🇸 South Bend, Indiana, United States

Our Lady of Mercy Medical Center, Comprehensive Cancer Center; 🇺🇸 Bronx, New York, United States

University of Michigan Cancer Center Complementary and Alternative Medicine Research Center; 🇺🇸 Ann Arbor, Michigan, United States

St. Joseph Mercy Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Community Clinic Oncology Program; 🇵🇷 San Juan, Puerto Rico