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NCT01921296 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients
A Phase 2 study, sponsored by Lynn Henry.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01921296: Clinical Trial Phase 2 study, sponsored by Lynn Henry.
NCT01921296 is a Phase 2 study that was terminated before completion, run by Lynn Henry. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921296, a Phase 2 study, was terminated before completion, sponsored by Lynn Henry.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.
Primary Outcome
Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine. A total score is calculated for the Pittsburgh Sleep Quality Index. The total score ranges from 0-21, with higher scores representing worse sleep quality. Any reduction in PSQI total score was considered an improvement.
Interventions
- DRUG Cyclobenzaprine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Why NCT01921296 stopped before completion
NCT01921296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cyclobenzaprine is the first listed.
NCT01921296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01921296 about?
NCT01921296 is a clinical study titled "Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients". Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do n...
What is the current status of trial NCT01921296?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-08. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01921296?
The interventions under investigation include: Cyclobenzaprine (DRUG).
Who is sponsoring clinical trial NCT01921296?
This trial is sponsored by Lynn Henry, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01921296's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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