Ginger in Treating Nausea in Patients 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.

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