Clinical trial · Interventional
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to insufficient accrual to meet prespecified statistical analysis requirements.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Control | Other | — | UNRESOLVED |
| Suvorexant Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Suvorexant with information on sleep hygiene
- description
- Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
- interventionNames
- Drug: Suvorexant Tablets
- type
- PLACEBO_COMPARATOR
- label
- Placebo with information on sleep hygiene
- description
- Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
- interventionNames
- Other: Placebo Control
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available