UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

University of Michigan Rogel Cancer Center180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

180

Conditions

Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific

Interventions

ginger extractDRUG

Given orally

placeboOTHER

Given orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (6)

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

University of Michigan Cancer Center CCOP Research Base

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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