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NCT06162663 · ClinicalTrials.gov registry record · Phase 4
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
A Phase 4 study, sponsored by Medical University of South Carolina.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT06162663: Clinical Trial Phase 4 study, sponsored by Medical University of South Carolina.
NCT06162663 is a Phase 4 study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06162663, a Phase 4 study, was terminated before completion, sponsored by Medical University of South Carolina.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Placebo Control
- DRUG Suvorexant Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2024-09-20 |
| Est. Completion | 2026-02-17 |
| Phase | Phase 4 |
Why NCT06162663 stopped before completion
NCT06162663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Control is the first listed.
NCT06162663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06162663 about?
NCT06162663 is a clinical study titled "Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors". 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 ...
What is the current status of trial NCT06162663?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2024-09-20. Estimated completion is 2026-02-17.
What interventions are being tested in trial NCT06162663?
The interventions under investigation include: Placebo Control (OTHER), Suvorexant Tablets (DRUG).
Who is sponsoring clinical trial NCT06162663?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06162663's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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