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Ginger Control of Chemotherapy Induced Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT00065221
Recruitment Status : Completed
First Posted : July 22, 2003
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Chemotherapy Drug: Ginger Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting
Study Start Date : June 2003
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065221


Locations
United States, Indiana
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, United States
United States, Michigan
University of Michigan Cancer Center Complementary and Alternative Medicine Research Center
Ann Arbor, Michigan, United States, 48104
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
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
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
More Information
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ClinicalTrials.gov Identifier: NCT00065221     History of Changes
Other Study ID Numbers: R21AT001735-01 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2003    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Ginger
Plant preparation
Herbal medicine
Chemotherapy
Nausea

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