The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Change in VO2peak
研究概览
简要总结
The purpose of this study is to compare the effects of aerobic exercise to usual care in women treated with chemotherapy and radiation therapy for non-metastatic breast cancer
详细描述
In this study, we will compare the effects of exercise between women previously treated with breast cancer to women with no history of any cancers. Therefore, in addition to a randomized controlled trial in women with previous breast cancer (i.e., an exerciser group and a control group), we also include a reference group comprising age-matched women with no history of any cancer diagnosis. Women in the reference group will undergo a similar exercise intervention and the exercise group. This study recruits through invitation only.
The primary endpoint in this study is the change in cardiorespiratory fitness, measured as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, endpoints derived from the cardiopulmonary exercise test and lung function assessments, cellular muscle endpoints derived from muscle biopsies obtained from m. vastus lateralis, also patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 28 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible BCS must be listed in the Norwegian Cancer registry
- •Adult-onset breast cancer diagnosis, diagnosed between 2008 and 2012
- •60 years or younger at the time of diagnosis
- •received anthracycline-based chemotherapy as a part of their treatment history
- •signed informed consent and medical doctors approveal of participation prior to inclusion
排除标准
- •Received Herceptin
- •Diagnosed with stage IV breast cancer
- •Relapse since diagnosis
- •A history, or current presence, of another diagnosis of invasive cancer of any kind
- •Selfreported severe fatigue
- •present with any uncontrolled- or recent cardiovascular disease, has undergone heart surgery or uses a pacemaker
- •currently exercising more than 90 minutes per week
结局指标
主要结局
Change in VO2peak
时间窗: From baseline to five months (post-intervention)
Peak oxygen uptake during a treadmill based cardiopulmonary exercise test
次要结局
- Fat mass(From baseline to five months (post-intervention))
- Muscle fiber type(From baseline to five months (post-intervention))
- Systolic- and diastolic longitudinal strain(From baseline to five months (post-intervention))
- Lean body mass(From baseline to five months (post-intervention))
- Systolic- and diastolic heart chamber dimensions(From baseline to five months (post-intervention))
- Muscle fiber area(From baseline to five months (post-intervention))
- Genome-wide DNA methylation and gene expression(From baseline to five months (post-intervention))
- Blood volume(From baseline to five months (post-intervention))
- Muscle mitochondria mass(From baseline to five months (post-intervention))
- Quality of life: Quality of Life Questionnaire (QLQ) C-30(From baseline to five months (post-intervention))
研究者
Tormod Skogstad Nilsen
PhD
Norwegian School of Sport Sciences