Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
This study has been completed.
Sponsor:
Gary Morrow
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00022074
First received: August 10, 2001
Last updated: March 4, 2013
Last verified: March 2013
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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 |
Drug: gabapentin Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Control of Vasomotor Symptoms in Women Treated for Breast Cancer |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
| Study Start Date: | July 2001 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
- Compare quality of life, anxiety, and depression in patients treated with these regimens.
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.
- Arm I: Patients receive oral placebo 3 times a day.
- Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
- Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.
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 |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Experiencing 2 or more hot flashes per day for at least 1 week
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin normal
- SGOT no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.25 times ULN
Cardiovascular:
- No coronary insufficiency
- No myocardial infarction within the past 3 months
- No symptomatic cardiac disease
- No peripheral vascular disease
- No cerebrovascular disease or stroke
- No syncope or symptomatic hypotension
Other:
- No history of allergic or other adverse reaction to gabapentin
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 1 week after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No other concurrent anticonvulsant medication
- No concurrent clonidine or venlafaxine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022074
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 - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| United States, Wisconsin | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
Sponsors and Collaborators
Gary Morrow
Investigators
| Study Chair: | Kishan J. Pandya, MD | James P. Wilmot Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Gary Morrow, Director, URCC CCOP Research Base, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00022074 History of Changes |
| Other Study ID Numbers: | CDR0000068780, URCC-U2101, NCI-P01-0183 |
| Study First Received: | August 10, 2001 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Rochester:
|
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 anxiety disorder depression hot flashes |
Additional relevant MeSH terms:
|
Anxiety Disorders Breast Neoplasms Depression Depressive Disorder Hot Flashes Mental Disorders Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Behavioral Symptoms Mood Disorders Signs and Symptoms Gabapentin Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013