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).
Female (both pre- and postmenopausal) or male patients
Age ≥18 years
Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III
Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction
Current history of moderate/severe depression and/or anxiety, both defined as grade≥2 CTCAE V5.0
History of suicide-related events
Current use of diuretics, antidepressants and/or phytoestrogens
Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine
Parallel
Duloxetine 60 MG
DrugPatients randomized to the duloxetine arm will take duloxetine orally daily, with or without food, on a continuous dosing schedule. Initial dose is 30 mg daily for 1 week, followed by 60 mg daily for a total of 6 months of treatment, followed by a taper off the medication of 30 mg daily for 1 additional week.
Furosemide 40 mg
DrugPatients randomized to the furosemide arm will take furosemide 40 mg orally daily, on an empty stomach with plenty of liquid, on a continuous dosing schedule.
Booklet for healthy behaviors
BehavioralAll patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects.
Endocrine therapy related musculoskeletal pain
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 musculoskeletal pain
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.
Overall quality of life
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.
Emotional functioning
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.
Endocrine therapy related symptoms
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.
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