umccop 02-01 ginger in treating nausea and vomiting in patients receiving chemotherapy for cancer

Conditions: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: the herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer. purpose: this randomized phase ii trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

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 (5-ht_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.

Eligibility 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 meets the following criteria: * agent is the same that is scheduled for the next round of chemotherapy * 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 * able to complete study questionnaires * no allergy to ginger prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics * no prior chemotherapy regimens with multiple day doses 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

Keywords: nausea and vomiting unspecified adult solid tumor, protocol specific