A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer
- 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
- Compare the chemotherapy-related anticipatory nausea in patients treated with these
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 2 (approximately 3-4 weeks on study drug)
Julie L. Ryan, PhD, MPH
University of Rochester
United States: Federal Government
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Greenville||Greenville, South Carolina 29615|
|MBCCOP - University of Illinois at Chicago||Chicago, Illinois 60612|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|MBCCOP - Gulf Coast||Mobile, Alabama 36688|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|