Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer
- Conditions
- ER+ Breast CancerHER2-negative Breast CancerBreast Cancer Stage IIIBreast Cancer Stage IDrug-Related Side Effects and Adverse ReactionsMusculoskeletal PainBreast Cancer Stage II
- Interventions
- Registration Number
- NCT06407401
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 399
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm (SoC) Booklet for healthy behaviors Standard of care (SoC) including a booklet focused on healthy behaviors Experimental arm SoC with duloxetine Duloxetine 60 MG Duloxetine 60 mg (1 pill a day) + SoC Experimental arm SoC with duloxetine Booklet for healthy behaviors Duloxetine 60 mg (1 pill a day) + SoC Experimental arm SoC with Furosemide Furosemide 40 mg Furosemide 40 mg (1 pill a day) + SoC Experimental arm SoC with Furosemide Booklet for healthy behaviors Furosemide 40 mg (1 pill a day) + SoC
- Primary Outcome Measures
Name Time Method Endocrine therapy related musculoskeletal pain 3 months Assessed by the Skeletal scale from the EORTC-QLQ-BR42 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means worse outcome.
- Secondary Outcome Measures
Name Time Method Overall quality of life 3 months and 6 months Assessed by the Global Health status/Quality of Life scale from the EORTC-QLQ-C30 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means better outcome.
Endocrine therapy related musculoskeletal pain 6 months Assessed by the Skeletal scale from the EORTC-QLQ-BR42 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means worse outcome.
Endocrine therapy related symptoms 3 months and 6 months Assessed by the endocrine therapy symptom scale from the EORTC-QLQ-BR42 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means worse outcome.
Discontinuation of endocrine therapy 6 months Proportion of patients who discontinued endocrine therapy
Emotional functioning 3 months and 6 months Assessed by the emotional functioning scale from the EORTC-QLQ-C30 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means better outcome.