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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2016-12-01
NCT01598298Uploaded 10-16-2018
Access via NCI by Request
PDS UID: nci-data-382
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 Information
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
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
Intervention TypeDrug: duloxetine hydrochloride
Other: placebo
Drug(s)Drug: duloxetine hydrochloride
Total Enrolled299
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Secondary IDS1202
PubMed (PMID)29136387
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range120 Years and younger (CHILD, ADULT, OLDER_ADULT)
Files: NCT01598298-D3
Data DictionaryNCT01598298-D3-Data-Dictionary.pdf
DATANCT01598298-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT01598298-D2
Data DictionaryNCT01598298-D2-Data-Dictionary.pdf
DATANCT01598298-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT01598298-D1
Data DictionaryNCT01598298-D1-Data-Dictionary.pdf
DATANCT01598298-D1-Dataset.csv
OTHERREADME.pdf
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