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

Study start date: May 1, 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