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

Primary Purpose

Sleep Initiation and Maintenance Disorders, Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclobenzaprine
Sponsored by
Lynn Henry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Initiation and Maintenance Disorders focused on measuring Breast cancer, Aromatase inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclobenzaprine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy
Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.
Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy
Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.

Full Information

First Posted
August 8, 2013
Last Updated
March 21, 2016
Sponsor
Lynn Henry
Collaborators
Damon Runyon Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01921296
Brief Title
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Accrual terminated early because of poor accrual
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lynn Henry
Collaborators
Damon Runyon Cancer Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Pain
Keywords
Breast cancer, Aromatase inhibitor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclobenzaprine
Arm Type
Experimental
Arm Description
Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Cyclobenzaprine
Other Intervention Name(s)
Flexeril
Intervention Description
5 milligrams orally 2 hours before bedtime
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy
Description
Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.
Time Frame
baseline and 8 weeks
Title
Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy
Description
Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.
Time Frame
baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy
Description
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
Time Frame
24 weeks
Title
Percentage of Patients That Experience Adverse Events
Description
Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norah L Henry, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0944
Country
United States

12. IPD Sharing Statement

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

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