Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
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.
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