Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Symptoms and General Pathology

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Fatigue

Dyssomnias

Parasomnias

Pain

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Sleep Disorders, Intrinsic

All Drugs and Chemicals

Central Nervous System Depressants

Muscle Relaxants, Central

Psychotropic Drugs

Aromatase Inhibitors

Cyclobenzaprine

Antidepressive Agents

Antidepressive Agents, Tricyclic

Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.

5 milligrams orally 2 hours before bedtime

Norah L Henry, MD, PhD

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.

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

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

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

Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria

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.

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.

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.

Damon Runyon Cancer Research Foundation

Lynn Henry

Assistant Professor of Internal Med

Age, Continuous

Sex: Female, Male

The study was closed early for futility. The primary endpoint was not analyzed.

Dr. Norah Lynn Henry, Associate Professor of Internal Medicine

Only one of the two enrolled participants completed questionnaires after the baseline assessment

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients	NCT01921296	Sleep Initiatio... Pain	Cyclobenzaprine	18 Years -	University of Michigan Rogel Cancer Center
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients	NCT01921296	Sleep Initiatio... Pain	Cyclobenzaprine	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for cyclobenzaprine