Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

Study Overview
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Brief Summary
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RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy. PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer.

Detailed Description
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OBJECTIVES: Compare the efficacy of 1 course of ginger vs placebo when administered in regimens containing a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic and dexamethasone (or the equivalent dose of IV methylprednisolone) in controlling chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer. Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients. Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients. Determine the adverse effects of these antiemetic regimens during the 4 days after chemotherapy. Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens. Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens. Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms. Day 1 of each course is defined as the day of chemotherapy administration. Placebo: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. 0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. 1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. 1.5g Ginger: Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a 5-hydroxytryptamine type-3 (5-HT3) receptor antagonist (ondansetron, granisetron, tropisetron, and dolasetron mesylate) and dexamethasone (DM) (or the equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of courses 2 and 3. Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3. Quality of life is assessed on day 4 of courses 1-3. Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3. PROJECTED ACCRUAL: A total of 706 patients will be accrued for this study within 3 years.

Official Title
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A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Dietary Supplement: ginger
* Other: placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of cancer and be scheduled to receive at least 3 courses of chemotherapy Scheduled to receive chemotherapy with no planned interruption by radiotherapy or surgery Chemotherapy courses must be separated by at least 2 weeks from day 1 to day 1 of next course Must have experienced nausea of any degree of severity after completion of the first study-related course of chemotherapy Received a prior 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone (DM) given at any dose and by any route (or equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of course 1 of chemotherapy Scheduled to receive a 5-HT3 receptor antagonist antiemetic with DM (or equivalent dose of IV MePRDL) on day 1 of courses 2 and 3 of chemotherapy No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm^3 at second course of chemotherapy No prior bleeding or blood coagulation disorder (e.g., thrombocytopenia or platelet dysfunction) Hepatic: No prior coagulation factor deficiency Renal: Not specified Cardiovascular: No prior vascular defect Other: Able to understand English No concurrent or impending bowel obstruction PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent interferon therapy Chemotherapy: See Disease Characteristics At least 6 months since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: See Disease Characteristics Other: No concurrent warfarin or heparin for therapeutic anticoagulation Concurrent low-dose warfarin for maintenance of venous access allowed Concurrent rescue medications for control of symptoms caused by the cancer or its treatment allowed as clinically indicated

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. | Other: placebo<br>* Given orally<br>|
| Experimental: 0.5g ginger<br>Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. | Dietary Supplement: ginger<br>* Given orally<br>Other: placebo<br>* Given orally<br>|
| Experimental: 1.0g ginger<br>Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. | Dietary Supplement: ginger<br>* Given orally<br>Other: placebo<br>* Given orally<br>|
| Experimental: 1.5g ginger<br>Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. | Dietary Supplement: ginger<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Peak Acute Nausea | Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings. Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure. Negative values for this outcome are favorable. | 3-4 days on study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Nausea Severity | Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings. Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure. Negative values for this outcome are favorable. | 3-4 days on study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, vomiting