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	Treatment or Intervention	Phase
Nausea Vomiting Chemotherapy	Drug: Ginger	Phase II

Further Study Details: 

Expected Total Enrollment:  180

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Corinne Atty      734-998-0016    corinnea@umich.edu
Sara Al-Rawi      734-998-0016    samis@umich.edu

Indiana
      Northern Indiana Cancer Research Consortium CCOP, South Bend,  Indiana,  United States; Not yet recruiting
Michigan
      St. Joseph Mercy Hospital, Ann Arbor,  Michigan,  48106,  United States; Recruiting
      Community Clinic Oncology Program, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      University of Michigan Cancer Center Complementary and Alternative Medicine Research Center, Ann Arbor,  Michigan,  48104,  United States; Recruiting
New York
      Our Lady of Mercy Medical Center, Comprehensive Cancer Center, Bronx,  New York,  10466,  United States; Recruiting
Puerto Rico
      Community Clinic Oncology Program, San Juan,  Puerto Rico; Not yet recruiting

Study chairs or principal investigators

Suzanna M Zick, ND, MPH,  Principal Investigator,  University of Michigan   

Study ID Numbers:  R21AT001735-01
Record last reviewed:  March 2005
Last Updated:  March 24, 2005
Record first received:  July 18, 2003
ClinicalTrials.gov Identifier:  NCT00065221
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08