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TERMINATED
NCT06162663
PHASE4

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

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-09-20

Completion Date

2026-02-17

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DRUG

Suvorexant Tablets

Suvorexant initially with 10-20 mg for 28 days

OTHER

Placebo Control

Matched Placebo Control for 28 days

Locations (1)

MUSC Department of Family Medicine

Charleston, South Carolina, United States