Breast Cancer, Insomnia
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGSuvorexant Tablets
Suvorexant initially with 10-20 mg for 28 days
OTHERPlacebo Control
Matched Placebo Control for 28 days
Sponsors
Medical University of South Carolina
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized double blind placebo controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI) | 4 weeks | The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Evaluated Using the SF-36 | 4 Weeks | Health-related quality of life was assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). We have reported the average domain score for the general health domain. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed. |
| Quality of Life Evaluated Using the Cancer Problems in Living Scale (CPIL) | 4 weeks | Problems related to living with cancer were assessed using the Cancer Problems of Living (CPIL) Scale. The CPIL consists of a multi-item list of cancer-related problems across practical, emotional, and social domains. Participants rate each problem based on perceived severity, with higher ratings indicating greater problem severity. Each item is scored on a scale of 0-2 with the composite score reported. Score range from 0 to 58. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed. |
| Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale | 4 weeks | Vasomotor symptoms were assessed using the Hot Flash Related Daily Interference Scale. This validated instrument measures the extent to which hot flashes interfere with daily activities and quality of life. Scores range from 0 to 100, with higher scores indicating greater interference due to vasomotor symptoms. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed. |
| Number of Participants Reported as Adherent Using the Simplified Medication Adherence Questionnaire (SMAQ) | 4 weeks | Medication adherence was assessed using the Simplified Medication Adherence Questionnaire (SMAQ). The SMAQ is a brief, participant-reported questionnaire composed of six multiple-choice questions evaluating medication-taking behavior. Non-adherence is indicated by any positive response suggesting missed doses or by reporting more than two missed doses during the preceding week. The outcome reported was the number of participants who were adherent based on this evaluation. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed. |
| Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI) | 2 weeks | The Insomnia Severity Index (ISI) score was evaluated at baseline, 2 weeks, and 4 weeks. The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed. |
| Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI) | 4 weeks | Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI asks participants to rate current pain, average pain, least pain, and worst pain on numeric rating scales ranging from 0 to 10, with higher scores indicating greater pain severity. A total pain severity score can be calculated by averaging these items. Score range is from 0 to 10. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Marrison, MD PhD
Medical University of South Carolina
Participant flow
Recruitment details
A total of 5 participants completed the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Pain Evaluation evaluated using the Brief Pain Inventory (BPI) | 2.75 Scores on a scale STANDARD_DEVIATION 2.5 |
| Participant reported insomnia symptoms evaluated using the Insomnia Severity Index (ISI) | 22.00 Total score STANDARD_DEVIATION 2.83 |
| Quality of Life evaluated using the Cancer Problems in Living Scale (CPIL) | 13.7 Scores on a scale STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
| Vasomotor Symptoms assessed using the Hot Flash Related Daily Interference Scale | 2.38 Scores on a scale STANDARD_DEVIATION 2.11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
None listed