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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162663
• Other study ID #: Pro00130637
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 30, 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: Sarah Marrison, MD PhD
• Phone: 843-876-1210
• Email: marrison[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cancer survivors have an incidence of sleep disturbance and insomnia higher than the general population, with significant potential implications on health outcomes including in survivorship domains and mortality outcomes. Available pharmacologic options for management of sleep disturbance are limited in efficacy and in their side effects. 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. Evaluation of breast cancer survivors on endocrine therapy uses a study population with high 5-year survival rate while retaining the capacity for recruitment and creating an opportunity to explore potential effects on vasomotor symptoms. Suvorexant has the potential to have a significant impact in cancer survivors not only on sleep related outcomes but also on cancer survivorship outcomes.

The purpose of the research study is to evaluate the ability of Suvorexant, a medication approved by the Food and Drug Administration (FDA) for insomnia, to treat sleep disturbance in breast cancer survivors on endocrine therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: April 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Suvorexant Tablets
Suvorexant initially with 10-20 mg for 28 days

Other:
• Placebo Control
Matched Placebo Control for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant reported insomnia symptoms evaluated using the Insomnia Severity Index (ISI)	The within-person change in Insomnia Severity Index (ISI) will be evaluated from baseline to 4 weeks. The ISI is a scored on a scale of 0-28 based on responses to 7 questions. Higher values indicate more severe symptoms of sleep disturbance.	Assessed at baseline, 2 weeks, 4 weeks
Secondary	Vasomotor Symptoms assessed using the Hot Flash Related Daily Interference Scale	Evaluation of Vasomotor Symptoms by the hot flash related daily interference scale. The hot flash related daily interference scale ranges from 0-100 with higher scores indicated a greater level of interference.	Assessed at baseline, 2 weeks, 4 weeks
Secondary	Quality of Life evaluated using the SF-36	Evaluation using the SF-36. The SF-36 evaluates 8 multi-item scales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). Scores for each of these scales is 0-100 with higher scores indicated a higher health care related quality of life.	Assessed at baseline, 4 weeks
Secondary	Quality of Life evaluated using the Cancer Problems in Living Scale (CPIL)	Evaluation using the Cancer Problems of Living (CPIL) Scale. The CPIL includes multi-item list of problems for which the participant classifies each problem based on severity.	Assessed at baseline, 4 weeks
Secondary	Pain Evaluation evaluated using the Brief Pain Inventory (BPI)	Evaluation conducted using the Brief Pain Inventory (BPI). Participants are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items. Higher scores indicated increased symptoms.	Assessed at baseline, 2 weeks, 4 weeks
Secondary	Medication Adherence	Evaluated using the simplified medication adherence questionnaire (SMAQ). The Simplified Medication Adherence Questionnaire (SMAQ) is a short questionnaire posed directly to the participant regarding medication-taking habits composed of 6 multiple choice questions. Positive responses or more than 2 reported missed doses over the past week indicates medication non-adherence.	Assessed at baseline, 4 weeks