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Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 2 wordsv4
  2. Study title revisedv3
  3. Secondary endpoints: details revised at 4 of 5 entries
    • Study title shortened, about 5 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy. The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).
Trial Details
NCT Number NCT06407401
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Conditions
(from sponsor)		 ER+ Breast Cancer, HER2-negative Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Drug-Related Side Effects and Adverse Reactions, Musculoskeletal Pain
Related terms Breast Neoplasms, Drug-Related Side Effects and Adverse Reactions, Musculoskeletal Pain
Enrollment 399 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov