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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Sleep Initiation and Maintenance Disorders Pain
Intervention	Drug: Cyclobenzaprine
Phase	Phase 2
Sponsor	Lynn Henry
Responsible Party	University of Michigan Cancer Center
ClinicalTrials.gov Identifier	NCT01921296
First Received	August 8, 2013
Last Updated	April 16, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	August 8, 2013
Last Updated Date	April 16, 2014
Start Date	August 2013
Estimated Primary Completion Date	March 2015
Current Primary Outcome Measures	Change in sleep quality between baseline and week 8 with 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.
Current Secondary Outcome Measures	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.

Descriptive Information[ + expand ][ + ]

Brief Title	Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients
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
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Condition	Sleep Initiation and Maintenance Disorders Pain
Intervention	Drug: Cyclobenzaprine 5 milligrams orally 2 hours before bedtime Other Names: Flexeril
Study Arm (s)	Experimental: Cyclobenzaprine Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	36
Estimated Completion Date	March 2015
Estimated Primary Completion Date	October 2014
Eligibility Criteria	Inclusion Criteria: - Female gender, age ≥ 18, postmenopausal. - Histologically proven stage 0-III invasive carcinoma of the breast - Initiating or have been receiving a standard dose of aromatase inhibitor therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily) for up to a total of 48 months of AI therapy. - Trouble sleeping during the past week. (After signing the informed consent document, subjects must also have a global PSQI score of ≥5) - ECOG performance status 0-2 (see Appendix A). Exclusion Criteria: - Known hypersensitivity to cyclobenzaprine or any of the inactive ingredients - Diagnosis of sleep apnea that is currently interfering with sleep or requiring CPAP, restless leg syndrome that is currently interfering with sleep or requiring medication, or Epworth sleepiness scale >10. - Subjects with a history of hypothyroidism must have been on a stable dose of thyroid replacement medicine for at least 3 months prior to enrollment - Treatment with steroids within 1 month - Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment. - Concurrent treatment with bupropion, MAO inhibitors, phenothiazines (including thioridazine), selegiline, tramadol, or medications known to prolong the QT interval (www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) - Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder - Known moderate or severe hepatic impairment - History of congestive heart failure or cardiac arrhythmia (other than atrial fibrillation); myocardial infarction within the past 6 months - Uncontrolled narrow-angle glaucoma - Pregnant or breast feeding - Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Cancer Center Answer Line 800-865-1125
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01921296
Other Study ID Numbers	UMCC 2013.051
Has Data Monitoring Committee	Yes
Information Provided By	University of Michigan Cancer Center
Study Sponsor	Lynn Henry
Collaborators	Damon Runyon Cancer Research Foundation
Investigators	Principal Investigator: Norah L Henry, MD, PhD University of Michigan
Verification Date	April 2014

Locations[ + expand ][ + ]

University of Michigan Comprehensive Cancer Center	Ann Arbor, Michigan, United States, 48109-0944 Contact: Cancer Center Answer Line \| 800-865-1125 Principal Investigator: Norah L Henry, MD, PhD Recruiting