S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy
|ClinicalTrials.gov Identifier: NCT01598298|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Musculoskeletal Complications Pain||Drug: duloxetine hydrochloride Other: placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||June 2013|
|Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||January 2019|
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.
- Average Joint Pain According to BPI-SF [ Time Frame: Up to 12 weeks ]Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine" (assessed at Weeks 2, 6 and 12).
- Worst Joint Pain According to the BPI-SF Worst Pain Score [ Time Frame: Up to 12 weeks ]Worst joint pain according to the BPI-SF worst pain score (item #2) at 12 weeks. This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
- Pain Interference According to the BPI-SF [ Time Frame: Up to 12 weeks ]Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating "Does not interfere" and 10 indicating "Completely interferes".
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598298
Show 714 Study Locations
|Principal Investigator:||N. Lynn Henry, MD, PhD||University of Michigan Cancer Center|
|Study Chair:||Anne F. Schott, MD||University of Michigan Cancer Center|