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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT06407401
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Duloxetine 60 MG — DRUG
    Patients 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 — DRUG
    Patients 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 — BEHAVIORAL
    All patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects.

Study Details

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).

Key Dates

First listed
May 9, 2024
Start date
Dec 31, 2024
Status verified
Nov 2024
Primary completion
Apr 18, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
399 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control arm (SoC)
    Standard of care (SoC) including a booklet focused on healthy behaviors
  • Experimental: Experimental arm SoC with duloxetine
    Duloxetine 60 mg (1 pill a day) + SoC
  • Experimental: Experimental arm SoC with Furosemide
    Furosemide 40 mg (1 pill a day) + SoC

Primary Outcome Measure

Endocrine therapy related musculoskeletal pain [ Time Frame: 3 months ]

Central Contacts

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