WITHDRAWN

Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

Conditions

Advanced Malignant Solid Neoplasm Delirium Hematopoietic and Lymphatic System Neoplasm Insomnia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Randomized, Open Label Trial of Orexin Receptor Antagonist for Insomnia in Hospitalized Patients With Cancer to Prevent Delirium

Quick Facts

Study Start:2025-02-26

Study Completion:2025-04-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT06834386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 times the upper limit of normal * History of obstructive lung disease other than asthma

Inclusion Criteria

Exclusion 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

* 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 times the upper limit of normal
* History of obstructive lung disease other than asthma

Contacts and Locations

Principal Investigator

Regina M. Mackey, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Regina M. Mackey, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-26

Study Completion Date2025-04-24

Study Record Updates

Study Start Date2025-02-26

Study Completion Date2025-04-24

Terms related to this study

Additional Relevant MeSH Terms

Advanced Malignant Solid Neoplasm
Delirium
Hematopoietic and Lymphatic System Neoplasm
Insomnia