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Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting


Phase 2
18 Years
N/A
Not Enrolling
Both
Nausea, Vomiting, Chemotherapy

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Trial Information

Trial of Encapsulated Ginger as a Treatment for 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Suzanna M Zick, ND, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Federal Government

Study ID:

R21 AT001735-01

NCT ID:

NCT00065221

Start Date:

June 2003

Completion Date:

January 2007

Related Keywords:

  • Nausea
  • Vomiting
  • Chemotherapy
  • Ginger
  • Plant preparation
  • Herbal medicine
  • Chemotherapy
  • Nausea
  • Nausea
  • Vomiting

Name

Location

St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Our Lady of Mercy Medical Center, Comprehensive Cancer CenterBronx, New York  10466
Northern Indiana Cancer Research Consortium CCOPSouth Bend, Indiana  
University of Michigan Cancer Center Complementary and Alternative Medicine Research CenterAnn Arbor, Michigan  48104
Community Clinic Oncology ProgramGrand Rapids, Michigan  49503