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| Sponsors and Collaborators: |
James P. Wilmot Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022074 |
Purpose
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.
PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
| Condition | Intervention |
|---|---|
|
Anxiety Disorder Breast Cancer Depression Hot Flashes Quality of Life |
Drug: gabapentin Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Placebo Control |
| Official Title: | Control of Vasomotor Symptoms in Women Treated for Breast Cancer |
| Study Start Date: | July 2001 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.
Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.
Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.
Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.
Patients are followed at week 12.
PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Incorporated | |
| Denver, Colorado, United States, 80224 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, New Jersey | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| United States, Wisconsin | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Study Chair: | Kishan J. Pandya, MD | James P. Wilmot Cancer Center |
More Information
| Study ID Numbers: | CDR0000068780, URCC-U2101, NCI-P01-0183 |
| Study First Received: | August 10, 2001 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00022074 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer |
stage IIIC breast cancer quality of life anxiety disorder depression hot flashes |
|
Neurotransmitter Agents Gabapentin Hot Flashes Psychotropic Drugs Quality of Life Calcium Channel Blockers Signs and Symptoms Mental Disorders Analgesics Breast Diseases Excitatory Amino Acids Depression Tranquilizing Agents Skin Diseases |
Breast Neoplasms Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Depressive Disorder Recurrence Behavioral Symptoms Calcium, Dietary Anxiety Disorders Mood Disorders Anti-Anxiety Agents Peripheral Nervous System Agents Anticonvulsants |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Hot Flashes Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Membrane Transport Modulators Signs and Symptoms Neoplasms by Site Mental Disorders Sensory System Agents |
Therapeutic Uses Analgesics Breast Diseases Excitatory Amino Acid Antagonists Tranquilizing Agents Depression Skin Diseases Central Nervous System Depressants Breast Neoplasms Cardiovascular Agents Antimanic Agents Depressive Disorder Pharmacologic Actions Behavioral Symptoms Neoplasms |
