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 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.
Sleep Initiation and Maintenance Disorders
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- 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 ] [ Designated as safety issue: No ]Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine.
- Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine.
- Change in Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Will measure pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine.
- Proportion of Subjects Who Continue to Take Aromatase Inhibitor Therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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
- Safety and Tolerability of Cyclobenzaprine Therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|