Status:
TERMINATED
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients
Lead Sponsor:
Lynn Henry
Collaborating Sponsors:
Damon Runyon Cancer Research Foundation
Conditions:
Sleep Initiation and Maintenance Disorders
Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01921296
Start Date
August 1 2013
End Date
April 1 2015
Last Update
April 20 2016
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0944