NCT03656731已完成不适用
Exercise in Older Women With Breast Cancer During Systemic Therapy - a Randomized Controlled Trial (Breast Cancer Exercise Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in the 30-second chair stand test
研究概览
简要总结
BREACE is a prospective randomized controlled trial. The aim is to investigate the effect of an exercise-based intervention among older participants with breast cancer treated with adjuvant or first-line systemic therapy.
The hypotheses: That the intervention will maintain or increase physical function levels, reduce symptoms and side effects, improve quality of life and psychological wellbeing, and prevent weight loss and muscle wasting
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
- Single (Outcomes Assessor)
盲法说明
All physical tests will be conducted by masked health care professionals.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must:
- •Be operated for primary breast cancer within 12 weeks or
- •Be diagnosed with locally advanced or metastatic breast cancer. Be treated with (neo)adjuvant or first or second-line palliative therapy defined as chemotherapy ± HER2 directed treatment, ± antihormonal treatment, antihormonal treatment ± HER 2, directed treatment ± CDK 4/6 inhibitor.
- •Be ≥ 65 years of age at the time of signing the informed consent form
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
- •Be able to speak and read Danish, and to provide a signed informed consent form.
排除标准
- •Participants with:
- •Any physical condition that hinder the execution of physical exercise training
- •Other types of cancer
- •Documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment
- •Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder written consent
- •Unstable medical disease or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months, based on the referring oncologist's assessment.
- •In patients with documented bone metastases:
- •A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.
结局指标
主要结局
Change in the 30-second chair stand test
时间窗: baseline, 6 weeks, 12 weeks and 24 weeks
To measure change over time in the lower extremity strength, the number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest, is registered.
次要结局
- Body weight(baseline, 6 weeks, 12 weeks and 24 weeks)
- The 6-meter Gait Speed Test(baseline, 6 weeks, 12 weeks and 24 weeks)
- Adherence to exercise sessions(Up to 12 weeks)
- Common Toxicity Criteria for Adverse Events version 4(up to 6 months)
- The 6-minute-walk-test(baseline, 6 weeks, 12 weeks and 24 weeks)
- Physical activity level(baseline and 12 weeks)
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30(baseline, 6 weeks, 12 weeks and 24 weeks)
- The 10-meter Gait Speed Test(baseline, 6 weeks, 12 weeks and 24 weeks)
- Stair climb test(baseline, 6 weeks, 12 weeks and 24 weeks)
- Inflammation(Data will be recorded from the medical records)
- Lengths of hospitalizations(up to 6 months)
- whole-body lean body mass (LBM)(baseline and 12 weeks)
- The Handgrip Strength Test(baseline, 6 weeks, 12 weeks and 24 weeks)
- whole-body mineral density(baseline and 12 weeks)
- Survival(up to 6 months)
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23(baseline, 6 weeks, 12 weeks and 24 weeks)
- M.D. Anderson Symptom Inventory (MDASI)(baseline, 6 weeks, 12 weeks and 24 weeks)
- Hospital Anxiety and Depression Scale (HADS)(baseline, 6 weeks, 12 weeks and 16 weeks)
- Body mass index(baseline, 6 weeks, 12 weeks and 24 weeks)
- whole-body fat mass(baseline and 12 weeks)
- Adverse events(up to 12 weeks)
- Number of hospitals admissions(up to 6 months)
- Causes of hospitalizations(up to 6 months)
研究者
Cecilia Margareta Lund
MD
Herlev and Gentofte Hospital
研究点 (2)
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