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 :
Completed
First Posted : May 15, 2012
Results First Posted : February 28, 2018
Last Update Posted : December 16, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | May 11, 2012 | ||||||
First Posted Date ICMJE | May 15, 2012 | ||||||
Results First Submitted Date ICMJE | January 31, 2018 | ||||||
Results First Posted Date ICMJE | February 28, 2018 | ||||||
Last Update Posted Date | December 16, 2022 | ||||||
Actual Study Start Date ICMJE | May 15, 2013 | ||||||
Actual Primary Completion Date | December 1, 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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".
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Original Primary Outcome Measures ICMJE |
Reduction in average joint pain according to BPI-SF assessed up to 12 weeks | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Reduction in worst joint pain according to the BPI-SF worst pain score assessed up to 12 weeks | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy | ||||||
Official Title ICMJE | A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer | ||||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to baseline pain score (4-6 vs 7-10), and prior taxane use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients complete the modified Brief Pain Inventory Short Form (BPI-SF) questionnaire at baseline and periodically during study treatment. Patients may also complete the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale, the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES), Global Rating of Change Scale, and the patient Health Questionnaire (PHQ-9). Patients undergo blood sample collection at baseline and periodically during treatment for correlative studies, including biomarker and genetic studies. After completion of study treatment, patients are followed up for 168 days. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Henry NL, Unger JM, Schott AF, Fehrenbacher L, Flynn PJ, Prow DM, Sharer CW, Burton GV, Kuzma CS, Moseley A, Lew DL, Fisch MJ, Moinpour CM, Hershman DL, Wade JL 3rd. Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202. J Clin Oncol. 2018 Feb 1;36(4):326-332. doi: 10.1200/JCO.2017.74.6651. Epub 2017 Nov 14. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
299 | ||||||
Original Estimated Enrollment ICMJE |
294 | ||||||
Actual Study Completion Date ICMJE | December 20, 2018 | ||||||
Actual Primary Completion Date | December 1, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 120 Years (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01598298 | ||||||
Other Study ID Numbers ICMJE | S1202 S1202 ( Other Identifier: SWOG ) U10CA037429 ( U.S. NIH Grant/Contract ) NCI-2012-01960 ( Other Identifier: NCI ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Southwest Oncology Group | ||||||
Original Responsible Party | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office | ||||||
Current Study Sponsor ICMJE | Southwest Oncology Group | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||
Investigators ICMJE |
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PRS Account | Southwest Oncology Group | ||||||
Verification Date | December 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |