Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors

NCT06162663 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00130637
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators propose a double-blind, placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. Breast cancer survivors have an increased risk of insomnia for which Suvorexant has the has the potential ability to impact to improve sleep related outcomes and cancer survivorship outcomes. Breast cancer survivors with sleep disturbance based on an Insomnia Severity Index Score (ISI) \>15 will be randomized to either Suvorexant or placebo, with both arms receiving education on sleep hygiene.

Conditions

Breast Cancer; Insomnia

Outcome Measures

Primary Outcomes (1)

• Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)

  The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study.

  4 weeks

Secondary Outcomes (8)

• Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale

  4 weeks

• Quality of Life Evaluated Using the SF-36

  4 Weeks

• Quality of Life Evaluated Using the Cancer Problems in Living Scale (CPIL)

  4 weeks

• Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)

  4 weeks

• Number of Participants Reported as Adherent Using the Simplified Medication Adherence Questionnaire (SMAQ)

  4 weeks

Study Arms (2)

Suvorexant with information on sleep hygiene

EXPERIMENTAL

Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.

Drug: Suvorexant Tablets

Placebo with information on sleep hygiene

PLACEBO COMPARATOR

Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.

Other: Placebo Control

Interventions

Suvorexant Tablets DRUG

Suvorexant initially with 10-20 mg for 28 days

Suvorexant with information on sleep hygiene

Placebo Control OTHER

Matched Placebo Control for 28 days

Placebo with information on sleep hygiene

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adult women with history of breast cancer on a selective estrogen modulators or aromatase inhibitors with symptoms of insomnia as characterized by an ISI score of 15 or more will be included in the study population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult post menopausal breast cancer survivors (female, \> 18 years old)
• current selective estrogen modulator or aromatase inhibitor use
• at least 6 weeks beyond completion of definitive treatment for breast cancer
• less than 5 years from time of diagnosis.

You may not qualify if:

• less than 6-month life expectancy
• current steroid use
• severe depression or anxiety
• severe hepatic impairment
• concurrent use of moderate or strong CYP3A inhibitors
• current receipt of hospice care
• severe mental illness
• current use of greater than 40 morphine milligram equivalents daily
• diagnosis of obstructive sleep apnea, narcolepsy or other sleep related illness other than insomnia
• pregnancy
• treatment with alternate pharmacotherapy for insomnia at the time of trial initiation
• menstrual cycle within the past year

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

MUSC Department of Family Medicine

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

In this trial, there was low accrual with 2 participants in one group and 3 participants in the other representing 11% of the intended sample size. As a result any summary statistics are at high risk of being misleading. As a result, no conclusions or statistical evaluation can or should be completed.

Results Point of Contact

• Title: Sarah Tucker Marrison
• Organization: Medical University of South Carolina

marrison@musc.edu

8438762912

Study Officials

• Sarah Marrison, MD PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Model Details: Randomized double blind placebo controlled trial

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: September 20, 2024
• Primary Completion: January 15, 2026
• Study Completion: February 17, 2026
• Last Updated: August 12, 2026
• Results First Posted: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)