Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
Data Collection
Mental Disorders+8
+ Breast Diseases
+ Breast Neoplasms
Supportive Care Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: * Compare the effect of venlafaxine or another serotonin-reuptake inhibitor with vs without zolpidem, in terms of sleep continuity, in women with breast cancer or at high risk for developing breast cancer who experience hot flushes and associated sleep disorders. * Compare quality of life in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified by concurrent use of serotonin-reuptake inhibitors (SRI). * Stratum 1 (no concurrent SRI): Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral venlafaxine once daily and oral zolpidem once daily for 5 weeks\*. * Arm II: Patients receive oral venlafaxine once daily and oral placebo once daily for 5 weeks\*. * Stratum 2 (concurrently on SRI): Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral zolpidem once daily for 5 weeks\*. * Arm II: Patients receive oral placebo once daily for 5 weeks\*. NOTE: \*After 5 weeks of study treatment, patients in stratum 1 may taper or continue venlafaxine over 2 weeks (for a total duration of venlafaxine use of 7 weeks); patients in arm I of both strata may taper or continue zolpidem over 1 week (for a total duration of zolpidem use of 6 weeks); continuation or tapering of drugs in both arms occurs in an open-label fashion off study. In both strata, treatment continues in the absence of unacceptable toxicity. In both strata, hot flushes, sleep continuity, sleep quality, and quality of life are assessed at baseline and at weeks 1, 3, and 6. PROJECTED ACCRUAL: A total of 119 patients will be accrued for this study within 20 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.119 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, United States