Clinical trial NCT06162663: Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
Official title: Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Insomnia
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-12-08
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blind placebo controlled trial
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participant reported insomnia symptoms evaluated using the Insomnia Severity Index (ISI)
timeFrame: Assessed at baseline, 2 weeks, 4 weeks
Secondary outcomes:
measure: Vasomotor Symptoms assessed using the Hot Flash Related Daily Interference Scale
timeFrame: Assessed at baseline, 2 weeks, 4 weeks
measure: Quality of Life evaluated using the SF-36
timeFrame: Assessed at baseline, 4 weeks
measure: Quality of Life evaluated using the Cancer Problems in Living Scale (CPIL)
timeFrame: Assessed at baseline, 4 weeks
measure: Pain Evaluation evaluated using the Brief Pain Inventory (BPI)
timeFrame: Assessed at baseline, 2 weeks, 4 weeks
measure: Medication Adherence
timeFrame: Assessed at baseline, 4 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Department of Family Medicine
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sarah Marrison, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: