MedTrace Logo

S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

NCT01598298 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2022-12-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

duloxetine hydrochloride

Given PO

OTHER

placebo

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • N. Lynn Henry, MD, PhD · University of Michigan Rogel Cancer Center

  • Anne F. Schott, MD · University of Michigan Rogel Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-15
Primary Completion
2016-12-01
Completion
2018-12-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598298 on ClinicalTrials.gov