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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
South Carolina
MUSC Department of Family Medicine
RECRUITING
Charleston
Contact Information
Primary
Sarah Marrison, MD PhD
marrison@musc.edu
843-876-1210
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 44
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov