RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of ginger in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

Condition	Treatment or Intervention	Phase
nausea and vomiting unspecified adult solid tumor, protocol specific	Drug: ginger  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: herbal medicine / botanical therapy  Procedure: nausea and vomiting therapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.

Secondary

• Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
• Compare the safety of these regimens in these patients.
• Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5H-3 antagonist vs NK1 antagonist).

• Arm I: Patients receive lower-dose oral ginger twice daily.
• Arm II: Patients receive higher-dose oral ginger twice daily.
• Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of cancer
• Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)
• Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only)
• Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and experienced nausea and/or vomiting of any severity (delayed or acute)
• Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy
• No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• No history of bleeding disorder
• No thrombocytopenia

Hepatic

• Not specified

Renal

• Not specified

Gastrointestinal

• Able to swallow capsules
• No gastric ulcer
• No clinical evidence of current or impending bowel obstruction

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to understand English or Spanish
• Able to complete study questionnaires
• No allergy to ginger

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:
• Total body irradiation
• Hemi-body
• Upper abdomen
• Abdominal-pelvic mantle
• Cranium (radiosurgery)
• Craniospinal radiotherapy

Surgery

• Not specified

Other

• More than 1 week since prior ginger (teas, capsules, tinctures)
• No other concurrent ginger (teas, capsules, tinctures)
• Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed
• No concurrent therapeutic-doses of warfarin, aspirin, or heparin
• Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      University of Michigan Cancer Center CCOP Research Base, Ann Arbor,  Michigan,  48109-0725,  United States; Recruiting
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48104,  United States; Recruiting
New York
      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States; Recruiting
Puerto Rico
      MBCCOP - San Juan, San Juan,  00921-3201,  Puerto Rico; Recruiting

Study chairs or principal investigators

Suzanna Zick, MPH, ND,  Study Chair,  University of Michigan Comprehensive Cancer Center   

Study ID Numbers:  CDR0000310163; CCUM-0201; NCT00064272
Record last reviewed:  August 2004
Last Updated:  March 10, 2005
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064272
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08