Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients (NCT06834386) | Clinical Trial Compass
WithdrawnPhase 4
Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients
Stopped: low/slow accrual
United States0Started 2025-02-26
Plain-language summary
This phase IV trial compares suvorexant with standard of care to standard of care alone for improving difficulty sleeping (insomnia) and reducing confusion (delirium) in hospitalized cancer patients. Delirium can lengthen hospitalization, increase the delay of cancer treatment and can even increase the risk of premature death. Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness. Giving suvorexant with standard of care to treat insomnia may be more effective compared to standard of care alone in reducing the development of delirium in hospitalized cancer patients.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Presence of advanced active malignancy and insomnia despite nonpharmacologic management
* Anticipated hospital course of at least 3 days post randomization as judged by the patient's primary inpatient team
* One or more of the following risk factors of delirium:
* Age 75 or above
* Hearing impairment
* Vision impairment
* Initiation of 8 or new medications since start of hospitalization
* Chronic kidney disease III or greater
* Congestive heart failure
* Hospitalization for 14 or more days
* Dehydration requiring ongoing use of intravenous (IV) hydration
* Electrolyte imbalance requiring ongoing correction
Exclusion Criteria:
* Inability to consent
* Current pregnancy
* Women of childbearing potential (defined as women under age 55 without a personal history of surgical or chemotherapy-induced sterility)
* Current or prior delirium in the active hospitalization
* Concurrent use of strong/moderate CYP3A4 inducers and inhibitors (including but not limited to -azole antifungals, amiodarone, phenytoin, carbamazepine, etc.)
* Use of any benzodiazepine, benzodiazepine receptor modulator, or first generation antihistamine class medication within 72 hours prior to enrollment
* Personal history of narcolepsy
* Personal history of other primary sleep disorders including obstructive sleep apnea
* Personal history of alcohol use disorder
* Personal history of substance use disorder
* Personal history of cirrhosis
* Transaminitis more than 3 tim…
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.