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Trial record 1 of 46 for:    CYCLOBENZAPRINE
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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
Sponsor:
Collaborator:
Damon Runyon Cancer Research Foundation
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design 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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cyclobenzaprine
Hide 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
Arm/Group Title Cyclobenzaprine
Hide Arm/Group Description Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
77.5
(77 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Patients That Experience an Improvement in Sleep Quality as Assessed Using the Pittsburgh Sleep Quality Index (PSQI) With 8 Weeks of Cyclobenzaprine Therapy.
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only one of the two enrolled participants completed questionnaires after the baseline assessment
Arm/Group Title Cyclobenzaprine
Hide Arm/Group Description:
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participant
1
2.Secondary Outcome
Title Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy
Hide Description Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only one of the two enrolled participants completed questionnaires after the baseline assessment
Arm/Group Title Cyclobenzaprine
Hide Arm/Group Description:
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Overall Number of Participants Analyzed 1
Mean (Full Range)
Unit of Measure: change in T score
1.3
(1.3 to 1.3)
3.Secondary Outcome
Title Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy
Hide Description Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only one of the two enrolled participants completed questionnaires after the baseline assessment
Arm/Group Title Cyclobenzaprine
Hide Arm/Group Description:
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Overall Number of Participants Analyzed 1
Mean (Full Range)
Unit of Measure: change in average pain
-2
(-2 to -2)
4.Other Pre-specified Outcome
Title Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy
Hide Description We will assess the number of patients who continue to take the original aromatase inhibitor medication at the 24 week timepoint, as assessed using patient self-report and medical records
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclobenzaprine
Hide Arm/Group Description:
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
100
5.Other Pre-specified Outcome
Title Percentage of Patients That Experience Adverse Events
Hide Description Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclobenzaprine
Hide Arm/Group Description:
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
100
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cyclobenzaprine
Hide Arm/Group Description Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
All-Cause Mortality
Cyclobenzaprine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cyclobenzaprine
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cyclobenzaprine
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Metabolism and nutrition disorders   
Hypercalcemia  1/2 (50.00%)  1
Nervous system disorders   
Nervous System Disorder - Other  1/2 (50.00%)  1
Psychiatric disorders   
Insomnia  2/2 (100.00%)  2
The study was closed early for futility. The primary endpoint was not analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Norah Lynn Henry, Associate Professor of Internal Medicine
Organization: University of Michigan Hospital
Phone: 734-936-4991
EMail: norahh@umich.edu
Layout table for additonal information
Responsible Party: Lynn Henry, University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01921296     History of Changes
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