Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Control of Vasomotor Symptoms in Women Treated for Breast Cancer

Conditions
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Anxiety Disorder, Breast Cancer, Depression, Hot Flashes

Intervention / Treatment
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* Drug: gabapentin
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gabapentin|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, 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, hot flashes