Trial Outcomes & Findings for Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain (NCT NCT01028352)

Results Overview

Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory \& reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

8 weeks

Results posted on

2013-08-08

Participant Flow

Between December 2008 and May 2010 35 subjects enrolled and completed baseline questionnaires in the University of Michigan comprehensive cancer center's outpatient hematolgy / oncology clinic

Participant milestones

Participant milestones
Measure	Duloxetine Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
Overall Study STARTED	35
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Duloxetine Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
Overall Study Ineligible due to baseline average pain	5
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine n=35 Participants Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Age Continuous	56 years STANDARD_DEVIATION .9 • n=93 Participants
Sex: Female, Male Female	35 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	35 participants n=93 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Subjects were considered evaluable for the primary endpoint if they met all eligibility criteria and took at least one dose of duloxetine

Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory \& reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.

Outcome measures

Outcome measures
Measure	Duloxetine n=29 Participants Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.	72.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 2, 4 , 6 and 8 weeks

A secondary measure is the percentage of patients treated with duloxetine who experience a sustained 30% reduction in average pain score from baseline to 8 weeks. Sustained 30% reduction is defined as at least 30% reduction in 24-hour average pain severity at the 8 week endpoint, with a 30% reduction from baseline at a visit at least 2 weeks prior to the last visit, and at least 20% reduction from baseline at every visit in between.

Outcome measures

Outcome measures
Measure	Duloxetine n=29 Participants Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)	60.9 %of participants with 30% pain reduction Interval 48.6 to 73.1

Adverse Events

Duloxetine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duloxetine n=29 participants at risk Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
General disorders Fatigue	24.1% 7/29 • Number of events 7 • 1 year and 5 months
Gastrointestinal disorders Constipation	20.7% 6/29 • Number of events 6 • 1 year and 5 months
Gastrointestinal disorders nausea	20.7% 6/29 • Number of events 6 • 1 year and 5 months
General disorders Headache	17.2% 5/29 • Number of events 5 • 1 year and 5 months
General disorders Dry mouth	17.2% 5/29 • Number of events 5 • 1 year and 5 months
General disorders Drowsiness	13.8% 4/29 • Number of events 4 • 1 year and 5 months
Gastrointestinal disorders Heartburn	10.3% 3/29 • Number of events 3 • 1 year and 5 months
General disorders Anxiety	10.3% 3/29 • Number of events 3 • 1 year and 5 months

Additional Information

Dr. Norah L. Henry

University of Michigan Comprehensive Cancer Center

Phone: 734-936-4991

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place