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

Musculoskeletal Pain Clinical Trial

Official title: Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer; A Pragmatic Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

Patients, identified by their clinicians as suffering from Grade 2 or above endocrine therapy-related musculoskeletal symptoms [joint/bone/muscle pain]) for, at least, 4 weeks before enrolment will be centrally randomized 1:1:1 between:

• Control arm: Standard of care (SoC) including a booklet focused on healthy behaviors

• Experimental arm: Duloxetine 60 mg (1 pill a day) + SoC

• Experimental arm: Furosemide 40 mg (1 pill a day) + SoC

Treatment duration will be 6 months. All patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects. Treatment administration and modifications as well as specific monitoring should be done in accordance to the SmPC of the corresponding drugs. ;

Related Conditions & MeSH terms

• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms
• Drug-Related Side Effects and Adverse Reactions
• ER+ Breast Cancer
• HER2-negative Breast Cancer
• Musculoskeletal Pain

• NCT number: NCT06407401
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: EORTC HQ
• Phone: +3227741611
• Email: eortc@eortc.org
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2024
• Completion date: November 30, 2028