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

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