Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Delirium; Insomnia; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Interview; Other: Best Practice; Other: Electronic Health Record Review; Drug: Suvorexant

Detailed Description

PRIMARY OBJECTIVE:

I. Feasibility of a subsequent full scale randomized clinical trial (RCT) conducted at Mayo Clinic using the same methodology as outlined in this protocol (as this study is a pilot).

SECONDARY OBJECTIVE:

I. To generate preliminary data to determine if inpatient standard of care (i.e. sleep enhancement) is followed in both a study arm receiving standard of care alone and one receiving standard of care plus suvorexant.

EXPLORATORY OBJECTIVES:

I. To collect preliminary data to investigate the hypotheses that use of suvorexant in addition to standard of care for hospitalized adults with cancer will result in a decreased incidence of delirium, increased time to onset of delirium, and decreased number of delirium days in hospital as compared to standard of care alone.

II. To build a data collection and analysis infrastructure for a full scale RCT at Mayo Clinic if feasibility is demonstrated.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive suvorexant orally (PO) once daily (QD) at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

ARM II: Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (suvorexant, standard of care); Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy; Other: Electronic Health Record Review; Ancillary studies; Drug: Suvorexant; Given PO; Other Names: MK-4305; Belsomra
Active Comparator: Arm II (standard of care); Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy; Other: Electronic Health Record Review; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Feasibility will be defined as the ability to recruit 14 patients to the study with 20% or less study attrition.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to standard of care	Adherence to standard of care will be compared within each arm and between arms. Will be monitored with adequate adherence being defined as at 5/7 patients in each group and a between-group difference of no more than 2.	Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first
Change in Insomnia Severity Index score	Reduction of at least two points will be defined as clinical improvement. The Insomnia Severity Index consists of 7 items related to current (i.e., last 2 weeks0 severity of insomnia problems. Three items are rated on a scale of 0-4 where 0=none; 1=mild; 2=moderate; 3=severe; and 4=very severe. The remaining items are answered on similar scales of 0-4 (e.g., 0=not at all; 1=a little; 2=somewhat; 3=much; 4=very much).	Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Regina M. Mackey, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): April 24, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neoplasms; Delirium; Sleep Initiation and Maintenance Disorders; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Hypnotics and Sedatives; Suvorexant
• Other Study ID Numbers: 24-005893 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2025-00771 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No