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

This study has been terminated.
(Accrual terminated early because of poor accrual)
Sponsor:
Collaborator:
Damon Runyon Cancer Research Foundation
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01921296
First received: August 8, 2013
Last updated: May 19, 2014
Last verified: May 2014
  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 Intervention Phase
Sleep Initiation and Maintenance Disorders
Pain
Drug: Cyclobenzaprine
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

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.


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.


Other Outcome Measures:
  • 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


Enrollment: 2
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclobenzaprine
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Drug: Cyclobenzaprine
5 milligrams orally 2 hours before bedtime
Other Name: Flexeril

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921296

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0944
Sponsors and Collaborators
Lynn Henry
Damon Runyon Cancer Research Foundation
Investigators
Principal Investigator: Norah L Henry, MD, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Lynn Henry, Assistant Professor of Internal Med, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01921296     History of Changes
Other Study ID Numbers: UMCC 2013.051
Study First Received: August 8, 2013
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
Breast cancer
Aromatase inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Sleep Disorders
Dyssomnias
Parasomnias
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sleep Disorders, Intrinsic
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Cyclobenzaprine
Amitriptyline
Aromatase Inhibitors
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on August 27, 2014