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

NCT01921296 | Terminated Phase 2 Results DMC

• 1 other identifier: UMCC 2013.051
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Keywords

Breast cancer; Aromatase inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  8 weeks

Secondary Outcomes (2)

• Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy

  baseline and 8 weeks

• Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy

  baseline and 8 weeks

Other Outcomes (2)

• Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy

  24 weeks

• Percentage of Patients That Experience Adverse Events

  24 weeks

Study Arms (1)

Cyclobenzaprine

EXPERIMENTAL

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

Drug: Cyclobenzaprine

Interventions

Cyclobenzaprine DRUG

5 milligrams orally 2 hours before bedtime

Also known as: Flexeril

Cyclobenzaprine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Lynn Henry: lead
• Damon Runyon Cancer Research Foundation: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0944, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain; Breast Neoplasms

Interventions

cyclobenzaprine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Norah Lynn Henry, Associate Professor of Internal Medicine
• Organization: University of Michigan Hospital

norahh@umich.edu

734-936-4991

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Internal Med

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 13, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 20, 2016
• Results First Posted: November 19, 2014

Record last verified: 2016-03

Locations

US (1)