Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Overview[ - collapse ][ - ]
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. |
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Condition | Anxiety Disorder Breast Cancer Depression Hot Flashes |
Intervention | Drug: gabapentin Procedure: quality-of-life assessment |
Phase | N/A |
Sponsor | Gary Morrow |
Responsible Party | University of Rochester |
ClinicalTrials.gov Identifier | NCT00022074 |
First Received | August 10, 2001 |
Last Updated | March 4, 2013 |
Last verified | March 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | August 10, 2001 |
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Last Updated Date | March 4, 2013 |
Start Date | July 2001 |
Estimated Primary Completion Date | June 2005 |
Current Primary Outcome Measures | Not Provided |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Gabapentin For the Control of Hot Flashes in Women With Breast Cancer |
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Official Title | Control of Vasomotor Symptoms in Women Treated for Breast Cancer |
Brief Summary | 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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care |
Condition |
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Intervention | Drug: gabapentin Procedure: quality-of-life assessment |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | June 2005 |
Estimated Primary Completion Date | June 2005 |
Eligibility 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 |
Gender | Female |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00022074 |
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Other Study ID Numbers | CDR0000068780 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | University of Rochester |
Study Sponsor | Gary Morrow |
Collaborators | National Cancer Institute (NCI) |
Investigators | Study Chair: Kishan J. Pandya, MD James P. Wilmot Cancer Center |
Verification Date | March 2013 |
Locations[ + expand ][ + ]
MBCCOP - Gulf Coast | Mobile, Alabama, United States, 36688 |
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CCOP - Greater Phoenix | Phoenix, Arizona, United States, 85006-2726 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona, United States, 85259-5404 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado, United States, 80224 |
MBCCOP - Hawaii | Honolulu, Hawaii, United States, 96813 |
CCOP - Central Illinois | Decatur, Illinois, United States, 62526 |
CCOP - Wichita | Wichita, Kansas, United States, 67214-3882 |
CCOP - Kalamazoo | Kalamazoo, Michigan, United States, 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota, United States, 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey, United States, 07601 |
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 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina, United States, 27104-4241 |
CCOP - Columbus | Columbus, Ohio, United States, 43206 |
CCOP - Dayton | Dayton, Ohio, United States, 45429 |
CCOP - Virginia Mason Research Center | Seattle, Washington, United States, 98101 |
CCOP - Northwest | Tacoma, Washington, United States, 98405-0986 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin, United States, 54449 |