S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy
RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.
PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.
|Breast Cancer Musculoskeletal Complications Pain||Drug: duloxetine hydrochloride Other: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
|Official Title:||A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer|
- Reduction in average joint pain according to BPI-SF assessed up to 12 weeks [ Time Frame: 12 weeks ]
- Reduction in worst joint pain according to the BPI-SF worst pain score assessed up to 12 weeks [ Time Frame: 12 weeks ]
- Reduction in pain interference according to the BPI-SF worst pain score assessed up to 12 weeks [ Time Frame: 12 weeks ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||November 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.
Drug: duloxetine hydrochloride
Other Name: NSC-744012
Placebo Comparator: Arm II
Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01598298
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|Principal Investigator:||N. Lynn Henry, MD, PhD||University of Michigan Cancer Center|
|Study Chair:||Anne F. Schott, MD||University of Michigan Cancer Center|