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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01028352
First received: December 8, 2009
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
Results First Received: January 30, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Duloxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Duloxetine  
STARTED     35  
COMPLETED     29  
NOT COMPLETED     6  
Ineligible due to baseline average pain                 5  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
    Duloxetine  
Number of Participants  
[units: participants]
 		  35  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation 		  56  ± .9  
Gender  
[units: participants]
 		 
Female     35  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     35  



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.   [ Time Frame: 8 weeks ]
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Measure Type Primary
Measure Title Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.
Measure Description 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.
Time Frame 8 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects were considered evaluable for the primary endpoint if they met all eligibility criteria and took at least one dose of duloxetine

Reporting Groups
  Description
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.

Measured Values
    Duloxetine  
Number of Participants Analyzed  
[units: participants]
 		  29  
Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.  
[units: percentage of participants]
 		  72.4  

No statistical analysis provided for Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.



2.  Secondary:   Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)   [ Time Frame: Baseline, 2, 4 , 6 and 8 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Norah L. Henry
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-936-4991
e-mail: norahh@umich.edu


Publications of Results:


Responsible Party: Lynn Henry, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01028352     History of Changes
Other Study ID Numbers: UMCC 2008.062, HUM00022455
Study First Received: December 8, 2009
Results First Received: January 30, 2012
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board