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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Suvorexant in helping breast cancer survivors who have trouble sleeping, a condition known as insomnia. The researchers want to see if this medication can improve sleep and overall quality of life for these survivors. Eligible participants are women over 18 years old who are postmenopausal, currently taking certain hormone medications, and have experienced sleep issues. They should be at least six weeks out from their cancer treatment and diagnosed within the last five years.

If you join the trial, you'll be randomly assigned to receive either Suvorexant or a placebo (which looks like the medication but doesn’t contain active ingredients). Both groups will also receive guidance on good sleep habits. The trial is currently recruiting participants, and it’s important to note that there are specific criteria for who can join, such as not having severe mental health issues or certain sleep disorders. This study aims to help improve sleep for breast cancer survivors, which can be a significant concern after treatment.

Gender

FEMALE

Eligibility 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