A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone

Fecha de inicio: 1 de noviembre de 2004

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