Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
NCT ID: NCT00040742
Last Updated: 2015-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
745 participants
INTERVENTIONAL
2003-03-31
2011-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
placebo
Given orally
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.
ginger
Given orally
placebo
Given orally
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.
ginger
Given orally
placebo
Given orally
1.5g ginger
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
ginger
Given orally
Interventions
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ginger
Given orally
placebo
Given orally
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Director, URCC CCOP Research Base
Principal Investigators
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Julie L. Ryan, PhD, MPH
Role: STUDY_CHAIR
University of Rochester
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
CCOP - North Shore University Hospital
Manhassett, New York, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
CCOP - Northwest
Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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URCC U1902
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-0114
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000069401
Identifier Type: -
Identifier Source: org_study_id
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