Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

• Arm I: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

• Arm II: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

• Arm III: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

• Arm IV: 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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

James P. Wilmot Cancer Center at University of Rochester Medical Center

Julie L. Ryan

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00040742
Information obtained from ClinicalTrials.gov on December 14, 2011

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