Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

Condition(s) targeted: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: dexamethasone (Drug); dolasetron mesylate (Drug); ginger extract (Drug); granisetron hydrochloride (Drug); methylprednisolone (Drug); ondansetron (Drug); tropisetron (Drug); botanical therapy (Procedure); nausea and vomiting therapy (Procedure)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Julie L. Ryan, PhD, MPH, Study Chair, Affiliation: University of Rochester

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: Randomized phase II/III trial to determine the effectiveness of antiemetic drugs with or without ginger in treating nausea in patients who are receiving chemotherapy for cancer.

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

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome: Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 2 (approximately 3-4 weeks on study drug)

Secondary outcome:

Effective dose of ginger for chemotherapy-related nausea as determined by Nausea and Vomiting Diary and Symptom Inventory at course 2 (approximately 3-4 weeks on study drug)

Adverse effects of ginger as determined by Symptom Inventory, Platelet Count Form, and AE Report at course 3

Efficacy of ginger on chemotherapy-related anticipatory nausea as determined by Nausea and Vomiting Diary and Symptom Inventory at course 3 (approximately 6-8 weeks on study drug)

Quality of life by Functional Assessment Cancer Therapy-General at course 3 (approximately 6-8 weeks on study drug)

Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 3 (approximately 6-8 weeks on study drug)

Detailed description: 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 chemotherapy course 3

in these patients.

- 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of cancer for which no more than 1 of at least 3 of the projected courses of

chemotherapy has been or is currently being administered

- 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

MBCCOP - Gulf Coast, Mobile, Alabama 36606, United States; Recruiting
Paul O. Schwarzenberger, MD, Phone: 251-433-9899

CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States; Recruiting
Lawrence M. Kasper, MD, Phone: 602-239-2413

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States; Recruiting
Dyon Kwon, Phone: 707-521-3814, Email: dkwon@rrmginc.com

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States; Recruiting
Brian F. Issell, MD, FACP, Phone: 808-586-3015, Email: brian@crch.hawaii.edu

CCOP - Central Illinois, Decatur, Illinois 62526, United States; Recruiting
James L. Wade, MD, Phone: 217-876-6617, Email: jlwade3@sbcglobal.net

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612-7323, United States; Recruiting
Judith Murray, Phone: 312-355-1472, Email: memurray@uic.edu

CCOP - Wichita, Wichita, Kansas 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP, Phone: 316-268-5784

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States; Recruiting
Raymond S. Lord, MD, Phone: 269-373-7458, Email: rlord@wmcc.org

CCOP - Metro-Minnesota, St. Louis Park, Minnesota 55416, United States; Recruiting
Patrick J. Flynn, MD, Phone: 952-993-1517, Email: patrick.flynn@usoncology.com

CCOP - Kansas City, Kansas City, Missouri 64131, United States; Recruiting
Rakesh Gaur, MD, Phone: 816-823-0555, Email: rgaur@saint-lukes.org

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York 13057, United States; Recruiting
Jeffrey J. Kirshner, MD, Phone: 315-472-7504, Email: jkirshner@hoacny.com

CCOP - North Shore University Hospital, Manhassett, New York 11030, United States; Recruiting
Vincent P. Vinciguerra, MD, Phone: 516-734-8954, Email: vvincigu@nshs.edu

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States; Recruiting
James N. Atkins, MD, Phone: 336-777-3088

CCOP - Columbus, Columbus, Ohio 43215, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-488-2118, Email: kueblep@ohiohealth.com

CCOP - Dayton, Dayton, Ohio 45429, United States; Recruiting
Howard M. Gross, MD, Phone: 937-395-8678

CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States; Recruiting
Keith S. Lanier, MD, Phone: 503-216-6262

CCOP - Greenville, Greenville, South Carolina 29615, United States; Recruiting
Jeffrey K. Giguere, MD, FACP, Phone: 864-241-6251

CCOP - Northwest, Tacoma, Washington 98405-0986, United States; Recruiting
Lauren K. Colman, MD, Phone: 253-403-5259, Email: lauren.colman@multicare.org

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States; Recruiting
Clinical Trials Office - CCOP - Marshfield Clinic Research Fou, Phone: 715-389-4457

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2003
Last updated: February 22, 2008