Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

Phase 4

Withdrawn

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

• Registration Number: NCT06834386
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-19
• Study Start: 2025-02-26
• Status Verified: 2025-04
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (suvorexant, standard of care)	Best Practice	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.
Arm I (suvorexant, standard of care)	Electronic Health Record Review	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.
Arm I (suvorexant, standard of care)	Interview	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.
Arm I (suvorexant, standard of care)	Questionnaire Administration	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.
Arm I (suvorexant, standard of care)	Suvorexant	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.
Arm II (standard of care)	Best Practice	Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
Arm II (standard of care)	Electronic Health Record Review	Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
Arm II (standard of care)	Interview	Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
Arm II (standard of care)	Questionnaire Administration	Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adherence to standard of care	Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first	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.
Change in Insomnia Severity Index score	Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States