Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Sleep improvement by biologic data and actigraphy data at the end of study treatment
研究概览
简要总结
RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy. Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer.
PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Not specified
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •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
- •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
- •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
- 另有 33 项未显示
排除标准
- 未提供
结局指标
主要结局
Sleep improvement by biologic data and actigraphy data at the end of study treatment
次要结局
- Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment