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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)

Tracking Information
First Submitted Date  ICMJE July 18, 2003
First Posted Date  ICMJE July 22, 2003
Last Update Posted Date January 25, 2008
Study Start Date  ICMJE June 2003
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00065221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ginger Control of Chemotherapy Induced Nausea and Vomiting
Official Title  ICMJE Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Nausea
  • Vomiting
  • Chemotherapy
Intervention  ICMJE Drug: Ginger
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
180
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00065221
Other Study ID Numbers  ICMJE R21AT001735-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP