Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)
研究概览
简要总结
Investigators propose a double-blind, placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. Breast cancer survivors have an increased risk of insomnia for which Suvorexant has the has the potential ability to impact to improve sleep related outcomes and cancer survivorship outcomes. Breast cancer survivors with sleep disturbance based on an Insomnia Severity Index Score (ISI) >15 will be randomized to either Suvorexant or placebo, with both arms receiving education on sleep hygiene.
详细描述
Cancer survivors have an incidence of sleep disturbance and insomnia higher than the general population, with significant potential implications on health outcomes including in survivorship domains and mortality outcomes. Available pharmacologic options for management of sleep disturbance are limited in efficacy and in their side effects. Investigators propose a double-blind placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. Evaluation of breast cancer survivors on endocrine therapy uses a study population with high 5-year survival rate while retaining the capacity for recruitment and creating an opportunity to explore potential effects on vasomotor symptoms. Suvorexant has the potential to have a significant impact in cancer survivors not only on sleep related outcomes but also on cancer survivorship outcomes.
The purpose of the research study is to evaluate the ability of Suvorexant, a medication approved by the Food and Drug Administration (FDA) for insomnia, to treat sleep disturbance in breast cancer survivors on endocrine therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult post menopausal breast cancer survivors (female, > 18 years old)
- •current selective estrogen modulator or aromatase inhibitor use
- •at least 6 weeks beyond completion of definitive treatment for breast cancer
- •less than 5 years from time of diagnosis.
排除标准
- •less than 6-month life expectancy
- •current steroid use
- •severe depression or anxiety
- •severe hepatic impairment
- •concurrent use of moderate or strong CYP3A inhibitors
- •current receipt of hospice care
- •severe mental illness
- •current use of greater than 40 morphine milligram equivalents daily
- •diagnosis of obstructive sleep apnea, narcolepsy or other sleep related illness other than insomnia
- •pregnancy
- •treatment with alternate pharmacotherapy for insomnia at the time of trial initiation
- •menstrual cycle within the past year
研究组 & 干预措施
Suvorexant with information on sleep hygiene
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
干预措施: Suvorexant Tablets (Drug)
Placebo with information on sleep hygiene
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
干预措施: Placebo Control (Other)
结局指标
主要结局
Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)
时间窗: 4 weeks
The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study.
次要结局
- Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale(4 weeks)
- Quality of Life Evaluated Using the SF-36(4 Weeks)
- Quality of Life Evaluated Using the Cancer Problems in Living Scale (CPIL)(4 weeks)
- Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)(4 weeks)
- Number of Participants Reported as Adherent Using the Simplified Medication Adherence Questionnaire (SMAQ)(4 weeks)
- Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale(2 weeks)
- Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)(2 weeks)
- Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)(2 weeks)
研究者
Sarah Tucker Marrison
Assistant Professor-Faculty
Medical University of South Carolina