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

Information source: University of Michigan Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Pain

Intervention: Cyclobenzaprine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Lynn Henry

Official(s) and/or principal investigator(s):
Norah L Henry, MD, PhD, Principal Investigator, Affiliation: University of Michigan

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: 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.

Secondary outcome:

Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy

Change in Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0944, United States
Additional Information

Starting date: August 2013
Last updated: May 26, 2015

Page last updated: August 20, 2015

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