Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

Gary Morrow745 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

745

Conditions

Nausea Vomiting

Interventions

gingerDIETARY_SUPPLEMENT

Given orally

placeboOTHER

Given orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (19)

MBCCOP - Gulf Coast

Mobile, Alabama, United States

MBCCOP - Hawaii

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

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.

Time frame: 3-4 days on study drug

Secondary Outcomes

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.

Time frame: 3-4 days on study drug

Data from ClinicalTrials.gov

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