OBJECTIVES: * Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer. * Compare adverse events in patients treated with these regimens. * Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. * Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule). Patients in both arms complete a hot flash diary at baseline and then daily during study treatment. Quality of life is assessed at baseline and then weekly during study treatment. PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.
DISEASE CHARACTERISTICS: * History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer * Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant * Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant * No monoamine oxidase inhibitors or tricyclics * No current evidence of malignant disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Performance status * ECOG 0-1 Life expectancy * At least 6 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Chemotherapy * More than 4 weeks since prior antineoplastic chemotherapy * No concurrent antineoplastic chemotherapy Endocrine therapy * More than 4 weeks since prior androgens, estrogens, or progestational agents * More than 2 weeks since prior dehydroepiandrosterone (DHEA) for treatment of hot flashes * No concurrent androgens, estrogens, or progestational agents, including oral contraceptives * No concurrent DHEA for treatment of hot flashes * Concurrent tamoxifen, raloxifene, or aromatase inhibitor therapy allowed if on a stable dose for at least 4 weeks prior to study entry and during study treatment Other * No prior gabapentin * More than 2 weeks since other prior treatment for hot flashes (e.g., clonidine or Bellergal-S®) * Concurrent vitamin E or soy supplements allowed if on a stable dose for at least 1 month prior to study entry and during study treatment * No other concurrent treatment for hot flashes (e.g., clonidine or Bellergal-S®) * No other concurrent antidepressants
están designados en este estudio
de ser asignado al grupo placebo