Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer; A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 399
- 主要终点
- Endocrine therapy related musculoskeletal pain
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control arm (SoC)
Standard of care (SoC) including a booklet focused on healthy behaviors
干预措施: Booklet for healthy behaviors (Behavioral)
Experimental arm SoC with duloxetine
Duloxetine 60 mg (1 pill a day) + SoC
干预措施: Duloxetine 60 MG (Drug)
Experimental arm SoC with duloxetine
Duloxetine 60 mg (1 pill a day) + SoC
干预措施: Booklet for healthy behaviors (Behavioral)
Experimental arm SoC with Furosemide
Furosemide 40 mg (1 pill a day) + SoC
干预措施: Furosemide 40 mg (Drug)
Experimental arm SoC with Furosemide
Furosemide 40 mg (1 pill a day) + SoC
干预措施: Booklet for healthy behaviors (Behavioral)
结局指标
主要结局
Endocrine therapy related musculoskeletal pain
时间窗: 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.
次要结局
- Overall quality of life(3 months and 6 months)
- Endocrine therapy related musculoskeletal pain(6 months)
- Endocrine therapy related symptoms(3 months and 6 months)
- Discontinuation of endocrine therapy(6 months)
- Emotional functioning(3 months and 6 months)