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

NCT ID: NCT06162663

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2026-11-01

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.

Detailed Description

Cancer survivors have an incidence of sleep disturbance and insomnia higher than the general population, with significant potential implications on health outcomes including in survivorship domains and mortality outcomes. Available pharmacologic options for management of sleep disturbance are limited in efficacy and in their side effects. 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. Evaluation of breast cancer survivors on endocrine therapy uses a study population with high 5-year survival rate while retaining the capacity for recruitment and creating an opportunity to explore potential effects on vasomotor symptoms. Suvorexant has the potential to have a significant impact in cancer survivors not only on sleep related outcomes but also on cancer survivorship outcomes.

The purpose of the research study is to evaluate the ability of Suvorexant, a medication approved by the Food and Drug Administration (FDA) for insomnia, to treat sleep disturbance in breast cancer survivors on endocrine therapy.

Conditions

Breast Cancer; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Suvorexant with information on sleep hygiene

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.

Group Type: EXPERIMENTAL

Suvorexant Tablets

Intervention Type: DRUG

Suvorexant initially with 10-20 mg for 28 days

Placebo with information on sleep hygiene

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.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: OTHER

Matched Placebo Control for 28 days

Interventions

Suvorexant Tablets

Suvorexant initially with 10-20 mg for 28 days

Intervention Type: DRUG

Placebo Control

Matched Placebo Control for 28 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Sarah Tucker Marrison

Assistant Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Marrison, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

MUSC Department of Family Medicine

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Marrison, MD PhD

Role: CONTACT

marrison@musc.edu

843-876-1210

Facility Contacts

Sarah Marrison

Role: primary

Other Identifiers

Pro00130637

Identifier Type: -

Identifier Source: org_study_id