Trial Outcomes & Findings for Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients (NCT NCT01921296)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Cyclobenzaprine Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclobenzaprine n=2 Participants Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Age, Continuous	77.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Only one of the two enrolled participants completed questionnaires after the baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cyclobenzaprine n=1 Participants Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
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.	1 participant

SECONDARY outcome

Timeframe: baseline and 8 weeks

Population: Only one of the two enrolled participants completed questionnaires after the baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cyclobenzaprine n=1 Participants Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy	1.3 change in T score Interval 1.3 to 1.3

SECONDARY outcome

Timeframe: baseline and 8 weeks

Population: Only one of the two enrolled participants completed questionnaires after the baseline assessment

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.

Outcome measures

Outcome measures
Measure	Cyclobenzaprine n=1 Participants Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy	-2 change in average pain Interval -2.0 to -2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

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

Outcome measures

Outcome measures
Measure	Cyclobenzaprine n=2 Participants Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy	100 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria

Outcome measures

Outcome measures
Measure	Cyclobenzaprine n=2 Participants Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Percentage of Patients That Experience Adverse Events	100 percentage of participants

Adverse Events

Cyclobenzaprine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cyclobenzaprine n=2 participants at risk Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Metabolism and nutrition disorders Hypercalcemia	50.0% 1/2 • Number of events 1
Psychiatric disorders Insomnia	100.0% 2/2 • Number of events 2
Nervous system disorders Nervous System Disorder - Other	50.0% 1/2 • Number of events 1

Additional Information

Dr. Norah Lynn Henry, Associate Professor of Internal Medicine

University of Michigan Hospital

Phone: 734-936-4991

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place