Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction

Date de début de l'étude : 1 mai 2004

DISEASE CHARACTERISTICS: * At increased risk of developing breast cancer, meeting 1 of the following criteria: * Diagnosis of 1 of the following: * Ductal carcinoma in situ * Invasive breast cancer * Lobular carcinoma in situ * Atypical ductal or lobular hyperplasia * Lobular carcinoma * Candidate for breast cancer risk reduction for any of the following: * Predisposing mutation in a breast cancer susceptibility gene * Prior chest radiotherapy for Hodgkin's disease * Gail model score \> 1.67% over 5 years * Experiencing daytime and nocturnal hot flushes at least 14 times per week within the past 2 weeks * Experiencing sleep disturbance, characterized by the presence of all of the following for ≥ 1 month: * ≥ 3 awakenings per night occurring ≥ 3 nights per week * Insomnia impedes daytime function * Hot flushes are the primary cause of insomnia (determined at baseline visit) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 to 65 Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * Not specified Hepatic * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No clinically significant cardiac disease * No uncontrolled hypertension within the past 3 months, defined as the following: * Diastolic blood pressure \> 95 mm Hg on \> 1 occasion * Systolic blood pressure \> 160 mm Hg on \> 1 occasion Pulmonary * No clinically significant respiratory disease Psychiatric * Beck depression inventory score ≤ 15 * No active panic or depressive disorder within the past month * No lifetime history of bipolar or psychotic disorder * No active substance-use disorders, including alcohol and benzodiazepines, within the past year * No suicidal or homicidal ideation * No hypomania or mania Other * No prior adverse reaction to venlafaxine or zolpidem * None of the following sleep disorders within the past 6 months: * Sleep apnea * Narcolepsy * Periodic limb movement disturbance * No abuse or misuse of study medication * No daytime sedation that interferes with ability to function * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 3 months since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * More than 1 month since prior regular use (\> 25% of the time) of oral, transdermal, or injection preparations of androgens, estrogens, or progestins * Vaginal suppositories and creams allowed * No concurrent regular use of oral, transdermal, or injection preparations of androgens, estrogens, or progestins Radiotherapy * See Disease Characteristics * More than 3 months since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics Other * More than 1 month since prior regular use (\> 25% of the time) of any of the following: * Hypnotic agents (e.g., benzodiazepines, zolpidem, zaleplon, trazodone, or diphenhydramine) * Clonidine * More than 1 month since prior antidepressants or other medications that are known to influence mood \> 25% of the time (no serotonin-reuptake inhibitors \[SRI\] stratum only) * Concurrent SRI required provided they were initiated ≥ 1 month ago at or above the minimum dose, including any of the following (concurrent SRI stratum only): * Fluoxetine * Paroxetine * Paroxetine CR * Sertraline * Citalopram * S-citalopram * Venlafaxine * Fluvoxamine * No concurrent warfarin * No concurrent hypnotic agents, clonidine, or antidepressants, or other medications known to influence sleep, or mood