Ginger Control of Chemotherapy Induced Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00065221
First received: July 18, 2003
Last updated: January 24, 2008
Last verified: January 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • Chemotherapy regimens with multiple-day doses
  • Clinical evidence of current or impending bowel obstruction or symptomatic brain metastases

    • Concurrent radiotherapy that is classified as high or intermediate risk of causing nausea and vomiting; total body irradiation, hemi-body, upper abdomen, abdominal-pelvic mantle, cranium, craniospinal irradiation
  • Pregnant or lactating
  • Patients with a history of a bleeding disorder(s) or those experiencing thrombocytopenia
  • Currently be taking ginger or have taken ginger in the last month
  • Have an allergy to ginger
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065221

Locations
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
University of Michigan Cancer Center Complementary and Alternative Medicine Research Center
Ann Arbor, Michigan, United States, 48104
Community Clinic Oncology Program
Grand Rapids, Michigan, United States, 49503
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
Sponsors and Collaborators
Investigators
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00065221     History of Changes
Other Study ID Numbers: R21 AT001735-01
Study First Received: July 18, 2003
Last Updated: January 24, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Ginger
Plant preparation
Herbal medicine
Chemotherapy
Nausea

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014