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A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
Provider Data DescriptionThis dataset will allow users to reproduce the results reported in the Journal of Clinical Oncology (Henry et al., JCO, 2017), which contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset299
# of Patients Control150
# of Patients Experimental150
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsBreast Cancer Musculoskeletal Complications Pain