Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
nausea and vomiting, unspecified adult solid tumor, protocol specific
Brief 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.
Detailed description
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.
Interventions
DRUGginger extract
Given orally
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
National Center for Complementary and Integrative Health (NCCIH)
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Most efficacious dose | — |
| Safety | — |
| Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting) | — |
Countries
Puerto Rico, United States
Outcome results
None listed