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Phase II/III Randomized Study of Ginger for Chemotherapy-Related Nausea in Patients With Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Basic Trial Information
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Sponsor
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Protocol IDs
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Phase III, Phase II
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Supportive care
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Active
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18 and over
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NCI
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URCC-U1902
URCC-0114, NCI-5857, NCI-P02-0223, NCT00040742
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy: - No concurrent interferon therapy
Chemotherapy: - See Disease Characteristics
- At least 6 months since other prior chemotherapy
Endocrine therapy: 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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Platelet count greater than 100,000/mm3 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: Cardiovascular: Other: - Able to understand English
- No concurrent or impending bowel obstruction
Expected Enrollment 706A total of 706 patients will be accrued for this study within 3 years. Outcomes Primary Outcome(s)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(s)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)
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.
Trial Contact Information
Trial Lead Organizations University of Rochester Cancer Center CCOP Research Base | | | | Julie Ryan, PhD, MPH, Protocol chair | | | |
Trial Sites
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| U.S.A. |
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| California |
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Santa Rosa |
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| | | | | | | | | CCOP - Santa Rosa Memorial Hospital |
| | | Dyon Kwon | |
| | Email:
dkwon@rrmginc.com |
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| Hawaii |
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Honolulu |
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| | | | MBCCOP - Hawaii |
| | | Brian Issell, MD, FACP | |
| | Email:
brian@crch.hawaii.edu |
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| Illinois |
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Chicago |
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| | | | MBCCOP - University of Illinois at Chicago |
| | | Judith Murray | |
| | Email:
memurray@uic.edu |
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Decatur |
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| | | CCOP - Central Illinois |
| | | James Wade, MD | |
| | Email:
jlwade3@sbcglobal.net |
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| Kansas |
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Wichita |
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| | | | CCOP - Wichita |
| | | Shaker Dakhil, MD, FACP | | Ph: | 316-268-5784 | | 800-362-5784 |
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| Michigan |
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Grand Rapids |
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| | | | CCOP - Grand Rapids |
| | | Marianne Lange, MD | |
| | Email:
marianne.lange@grcop.org |
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Kalamazoo |
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| | | CCOP - Kalamazoo |
| | | Raymond Lord, MD | |
| | Email:
rlord@wmcc.org |
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| Minnesota |
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St. Louis Park |
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| | | | CCOP - Metro-Minnesota |
| | | Patrick Flynn, MD | |
| | Email:
patrick.flynn@usoncology.com |
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| Missouri |
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Kansas City |
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| | | | CCOP - Kansas City |
| | | Rakesh Gaur, MD | |
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rgaur@saint-lukes.org |
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| Nevada |
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Las Vegas |
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| | | | CCOP - Nevada Cancer Research Foundation |
| | | John Ellerton, MD, CM | |
| | Email:
sncrf@hotmail.com |
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| New York |
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East Syracuse |
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| | | | CCOP - Hematology-Oncology Associates of Central New York |
| | | Jeffrey Kirshner, MD | |
| | Email:
jkirshner@hoacny.com |
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Manhassett |
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| | | CCOP - North Shore University Hospital |
| | | Vincent Vinciguerra, MD | |
| | Email:
vvincigu@nshs.edu |
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| North Carolina |
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Goldsboro |
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| | | | CCOP - Southeast Cancer Control Consortium |
| | | James Atkins, MD | |
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| Ohio |
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Columbus |
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| | | | CCOP - Columbus |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
kueblep@ohiohealth.com |
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| Oregon |
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Portland |
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| | | | CCOP - Columbia River Oncology Program |
| | | Keith Lanier, MD | |
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| South Carolina |
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Greenville |
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| | | | CCOP - Greenville |
| | | Jeffrey Giguere, MD, FACP | |
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| Washington |
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Tacoma |
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| | | | CCOP - Northwest |
| | | Lauren Colman, MD | |
| | Email:
lauren.colman@multicare.org |
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| Wisconsin |
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Marshfield |
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| | | | CCOP - Marshfield Clinic Research Foundation |
| | | Clinical Trials Office - CCOP - Marshfield Clinic Research Foundation | |
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| Registry Information | | | Official Title | | A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer | | | Trial Start Date | | 2003-03-26 | | | Trial Completion Date | | 2009-12-31 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00040742 | | | Date Submitted to PDQ | | 2002-04-29 | | | Information Last Verified | | 2008-10-15 | | | NCI Grant/Contract Number | | CA037420 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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