Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

NCT ID: NCT06834386

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2025-04-24

Brief 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.

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.

Conditions

Advanced Malignant Solid Neoplasm; Delirium; Hematopoietic and Lymphatic System Neoplasm; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Best Practice

Intervention Type: OTHER

Receive standard of care

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Interview

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Suvorexant

Intervention Type: DRUG

Given PO

Arm II (standard of care)

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

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive standard of care

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Interview

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive standard of care

Intervention Type: OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Interview

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Suvorexant

Given PO

Intervention Type: DRUG

Other Intervention Names

standard of care; standard therapy; Belsomra; MK-4305

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regina M. Mackey, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2025-00771

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-005893

Identifier Type: OTHER

Identifier Source: secondary_id

24-005893

Identifier Type: -

Identifier Source: org_study_id