Status:
RECRUITING
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Insomnia
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 ...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06162663
Start Date
September 20 2024
End Date
November 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
MUSC Department of Family Medicine
Charleston, South Carolina, United States, 29425