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
|Condition or disease||Intervention/treatment||Phase|
|Sleep Initiation and Maintenance Disorders Pain||Drug: Cyclobenzaprine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||UMCC 2013.051: Prospective Pilot Study Evaluating the Use of Cyclobenzaprine for Treatment of Sleep Disturbance, Fatigue, and Musculoskeletal Symptoms in Aromatase Inhibitor-treated Breast Cancer Patients|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||April 2015|
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
5 milligrams orally 2 hours before bedtime
Other Name: Flexeril
- 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. [ Time Frame: 8 weeks ]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.
- Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy [ Time Frame: baseline and 8 weeks ]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.
- Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy [ Time Frame: baseline and 8 weeks ]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.
- Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy [ Time Frame: 24 weeks ]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
- Percentage of Patients That Experience Adverse Events [ Time Frame: 24 weeks ]Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921296
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0944|
|Principal Investigator:||Norah L Henry, MD, PhD||University of Michigan|