Comparing Suvorexant to placebo for treating insomnia in breast cancer survivors
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
This study is testing if a sleep medication called Suvorexant can help breast cancer survivors who have trouble sleeping feel better and improve their quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06162663 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Suvorexant, a medication approved for insomnia, in improving sleep quality among breast cancer survivors who are currently on selective estrogen receptor modulators or aromatase inhibitors. Participants will be randomly assigned to receive either Suvorexant or a placebo, with both groups receiving education on sleep hygiene. The study aims to assess the impact of Suvorexant on insomnia symptoms and overall quality of life, particularly in a population known to experience higher rates of sleep disturbances. The trial will include adult postmenopausal women who have completed their breast cancer treatment and are experiencing significant insomnia.
Who should consider this trial
Good fit: Ideal candidates are adult postmenopausal women who are breast cancer survivors currently using selective estrogen receptor modulators or aromatase inhibitors and experiencing insomnia.
Not a fit: Patients with severe mental health issues, obstructive sleep apnea, or those currently receiving other insomnia treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for insomnia in breast cancer survivors, potentially improving their quality of life.
How similar studies have performed: While there have been studies on insomnia treatments in cancer patients, the specific use of Suvorexant in this population is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * less than 6-month life expectancy * current steroid use * severe depression or anxiety * severe hepatic impairment * concurrent use of moderate or strong CYP3A inhibitors * current receipt of hospice care * severe mental illness * current use of greater than 40 morphine milligram equivalents daily * diagnosis of obstructive sleep apnea, narcolepsy or other sleep related illness other than insomnia * pregnancy * treatment with alternate pharmacotherapy for insomnia at the time of trial initiation * menstrual cycle within the past year
Where this trial is running
Charleston, South Carolina
- MUSC Department of Family Medicine — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Marrison, MD PhD — Medical University of South Carolina
- Study coordinator: Sarah Marrison, MD PhD
- Email: marrison@musc.edu
- Phone: 843-876-1210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.