This phase IV trial compares the use of suvorexant to a placebo for the treatment of insomnia in women with breast cancer. Cancer survivors have a higher incidence of sleep disturbance and insomnia than the general population. Sleep disturbances and insomnia can have significant potential implications on health outcomes including in quality of life and survivorship. Suvorexant is a treatment for insomnia that works by blocking receptors that cause the body to feel wakefulness. Giving suvorexant may be effective in treating insomnia in women with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06162663.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Sarah Tucker Marrison
PRIMARY OBJECTIVES:
I. To evaluate the self-reported efficacy of suvorexant for the treatment of insomnia in breast cancer survivors at least 6 weeks beyond completion of definitive treatment and less than 5 years from time of initial diagnosis.
II. To assess the impact of suvorexant on quality of life in breast cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive suvorexant orally (PO), once daily (QD) 30 minutes prior to bedtime on days 1-28.
ARM II: Patients receive placebo PO QD 30 minutes prior to bedtime on days 1-28.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationMedical University of South Carolina
Principal InvestigatorSarah Tucker Marrison