Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of I… (NCT06162663) | Clinical Trial Compass
TerminatedPhase 4
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
Stopped: Terminated early due to insufficient accrual to meet prespecified statistical analysis requirements.
United States6 participantsStarted 2024-09-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)