Breast Cancer Exercise Intervention Study (BREXINT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,156
- 试验地点
- 6
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.
详细描述
This is a multi-centre, randomised controlled study of a 6-month (24-week) exercise programme versus observation in 2156 early stage and locally advanced breast cancer patients who have undergone curative breast surgery, and who have completed (neo)adjuvant chemotherapy (if given) or radiotherapy (if given). Patients are stratified by centre (NCC/SGH, NUH), menopausal status, ER/PR status, body fat/muscle ratio.
Cardiorespiratory fitness, muscle strength, level of routine daily physical activity, body fat/muscle ratio are monitored during the study period.
Blood is collected at baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks, then annually for 4 times.
Questionnaires are periodically conducted to assess quality of life (QoL). A food diary is kept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer
- •Patients who have undergone curative breast surgery
- •Patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given)
- •Females aged 21 years and older
- •≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.
排除标准
- •Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.
- •Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: Up to 5 years.
From the date of randomization to when an event, i.e. relapse, has occurred.
次要结局
- Overall Survival (OS)(Up to 5 years.)