Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
This study has been completed.
Sponsor:
University of Rochester
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00040742
First received: July 8, 2002
Last updated: November 8, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: ginger extract Other: placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 2 (approximately 3-4 weeks on study drug) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) [ Designated as safety issue: No ]
- Adverse effects of ginger as determined by Symptom Inventory, Platelet Count Form, and AE Report at course 3 [ Designated as safety issue: Yes ]
- 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) [ Designated as safety issue: No ]
- Quality of life by Functional Assessment Cancer Therapy-General at course 3 (approximately 6-8 weeks on study drug) [ Designated as safety issue: No ]
- Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 3 (approximately 6-8 weeks on study drug) [ Designated as safety issue: No ]
| Estimated Enrollment: | 706 |
| Study Start Date: | March 2003 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm I
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
|
Other: placebo
Given orally
|
|
Experimental: Arm II
Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
|
Dietary Supplement: ginger extract
Given orally
Other: placebo
Given orally
|
|
Experimental: Arm III
Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
|
Dietary Supplement: ginger extract
Given orally
Other: placebo
Given orally
|
|
Experimental: Arm IV
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
|
Dietary Supplement: ginger extract
Given orally
|
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 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040742
Locations
| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36606 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| East Syracuse, New York, United States, 13057 | |
| CCOP - North Shore University Hospital | |
| Manhassett, New York, United States, 11030 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
Sponsors and Collaborators
University of Rochester
Investigators
| Study Chair: | Julie L. Ryan, PhD, MPH | University of Rochester |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00040742 History of Changes |
| Other Study ID Numbers: | CDR0000069401, U10CA037420, URCC-U1902, URCC-0114, NCI-5857, NCI-P02-0223 |
| Study First Received: | July 8, 2002 |
| Last Updated: | November 8, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Rochester:
|
nausea and vomiting unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013