drugset / Trial / NCT01921296

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

NCT01921296 ↗

NaSingle-groupOpen-labelSupportive care

Summary

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.

Timeline

Start
2013-08
Primary completion
2014-05
Completion
2015-04

Outcome

Outcome not reported

Stopped (Enrollment): “Accrual terminated early because of poor accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject cyclobenzaprine Unknown 5 mg Oral