Overview

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

Status:
Not yet recruiting

Trial end date:
2026-04-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Medical University of South Carolina

Collaborator:

Merck Sharp & Dohme LLC

Treatments:

Suvorexant