S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy
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|ClinicalTrials.gov Identifier: NCT01598298|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Results First Posted : February 28, 2018
Last Update Posted : April 2, 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|
|Actual 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: Weeks 2, 6, 12, and 24; Week 12 reported ]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".
- Worst Joint Pain According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]Worst joint pain according to the BPI-SF worst pain score (item #2). 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: Weeks 2, 6, 12, and 24; Week 12 reported ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|