Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT01921296 |
Recruitment Status :
Terminated
(Accrual terminated early because of poor accrual)
First Posted : August 13, 2013
Results First Posted : November 19, 2014
Last Update Posted : April 20, 2016
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Sponsor:
Lynn Henry
Collaborator:
Damon Runyon Cancer Research Foundation
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Rogel Cancer Center
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care |
Conditions |
Sleep Initiation and Maintenance Disorders Pain |
Intervention |
Drug: Cyclobenzaprine |
Enrollment | 2 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cyclobenzaprine |
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Arm/Group Description | Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks. |
Period Title: Overall Study | |
Started | 2 |
Completed | 2 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Cyclobenzaprine | |
---|---|---|
Arm/Group Description | Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks. | |
Overall Number of Baseline Participants | 2 | |
Baseline Analysis Population Description |
[Not Specified]
|
|
Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 2 participants | |
77.5
(77 to 78)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2 participants | |
Female |
2 100.0%
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|
Male |
0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
The study was closed early for futility. The primary endpoint was not analyzed.
More Information
Results Point of Contact
Name/Title: | Dr. Norah Lynn Henry, Associate Professor of Internal Medicine |
Organization: | University of Michigan Hospital |
Phone: | 734-936-4991 |
EMail: | norahh@umich.edu |
Responsible Party: | Lynn Henry, University of Michigan Rogel Cancer Center |
ClinicalTrials.gov Identifier: | NCT01921296 |
Other Study ID Numbers: |
UMCC 2013.051 |
First Submitted: | August 8, 2013 |
First Posted: | August 13, 2013 |
Results First Submitted: | November 12, 2014 |
Results First Posted: | November 19, 2014 |
Last Update Posted: | April 20, 2016 |