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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213

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

Intervention / Treatment
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* Drug: ginger extract
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive lower-dose oral ginger twice daily. | Drug: ginger extract<br>* Given orally<br>|
| Experimental: Arm II<br>Patients receive higher-dose oral ginger twice daily. | Drug: ginger extract<br>* Given orally<br>|
| Placebo Comparator: Arm III<br>Patients receive oral placebo twice daily. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, unspecified adult solid tumor, protocol specific