Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test
研究概览
简要总结
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant or néoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females between 18 and 75 years of age;
- •signed written informed consent;
- •willing to take part in the trial and to follow the instructions;
- •breast tumour, histologically documented;
- •patients for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3FEC100 +3 taxanes or 6 FEC) +/- radiotherapy+/- Herceptin has been scheduled;
排除标准
- •metastatic cancer;
- •disability preventing a proper understanding of the instructions for the trial;
- •patients who are subject to a court protection, wardship or guardianship order;
- •uncontrolled hypertension;
- •family history of sudden death in a first-degree relative;
- •unstabilised heart disease;
- •current treatment with beta-blockers;
- •chronic or acute pulmonary disease associated with dyspnoea upon moderate effort;
- •uncontrolled thyroid dysfunction;
- •uncontrolled diabetes;
- •any other serious conditions that are unstabilised,
- •disabling or in which physical exercise is contra-indicated;
- •unable to attend for follow-up throughout the duration of the study;
- •ventricular ejection fraction (VEF) < 50%, pregnancy or suckling.
研究组 & 干预措施
Arm A
6-month ETP, during adjuvant or neoadjuvant therapy
干预措施: physical activity (Other)
Arm B
6-month ETP, after adjuvant or neoadjuvant therapy
干预措施: physical activity (Other)
Arm C
12-monthETP, during and after adjuvant or neoadjuvant treatment
干预措施: physical activity (Other)
结局指标
主要结局
The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test
时间窗: at 12 months
unit of measure:ml/kg/min
次要结局
- Exercise tolerance at 12 months (group A vs B)(at 12 months)