RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-20
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06162663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult post menopausal breast cancer survivors (female, \> 18 years old)
  2. * current selective estrogen modulator or aromatase inhibitor use
  3. * at least 6 weeks beyond completion of definitive treatment for breast cancer
  4. * less than 5 years from time of diagnosis.
  1. * less than 6-month life expectancy
  2. * current steroid use
  3. * severe depression or anxiety
  4. * severe hepatic impairment
  5. * concurrent use of moderate or strong CYP3A inhibitors
  6. * current receipt of hospice care
  7. * severe mental illness
  8. * current use of greater than 40 morphine milligram equivalents daily
  9. * diagnosis of obstructive sleep apnea, narcolepsy or other sleep related illness other than insomnia
  10. * pregnancy
  11. * treatment with alternate pharmacotherapy for insomnia at the time of trial initiation
  12. * menstrual cycle within the past year

Contacts and Locations

Study Contact

Sarah Marrison, MD PhD
CONTACT
843-876-1210
marrison@musc.edu

Principal Investigator

Sarah Marrison, MD PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

MUSC Department of Family Medicine
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Sarah Marrison, MD PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-20
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2024-09-20
Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • Insomnia