A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer
18 Years
N/A
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By 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.
- 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 2 (approximately 3-4 weeks on study drug)
Safety Issue:
No
Principal Investigator
Julie L. Ryan, PhD, MPH
Investigator Role:
Study Chair
Investigator Affiliation:
University of Rochester
Authority:
United States: Federal Government
Study ID:
CDR0000069401
NCT ID:
NCT00040742
Start Date:
March 2003
Completion Date:
April 2010
Related Keywords:
- Nausea and Vomiting
- Unspecified Adult Solid Tumor, Protocol Specific
- nausea and vomiting
- unspecified adult solid tumor, protocol specific
- Nausea
- Vomiting
Name | Location |
|---|---|
| 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 |
