Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients
|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
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|