Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
研究概览
简要总结
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.
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 chemotherapy.
详细描述
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 chemotherapy.
A total of 44 subjects is required. The programme is organised as follows: Arm A (aerobic and strength training) and during the 27 weeks of treatment (chemotherapy and radiotherapy); Arm B (control group). This study includes 3 assessments phases (T0: before adjuvant chemotherapy; T1 (week 27) and T2: final evaluation at the 54th week). These assessments include: cardiopulmonary exercise test including maximal oxygen uptake test (VO2max), six-minute walk test, muscular testing, assessment of physical activity (IPAQ questionnaire), fatigue (MFI20 questionnaire), quality of life (EORTC QLQ C30), anxiety and depression symptoms (HADS) and nutritional evaluation: BMI and total body photonic absorption.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 who have undergone curative surgery
- •patients for whom a 6-treatment course of adjuvant chemotherapy (3FEC100 + taxanes) and radiotherapy has been scheduled
- •patients with HER2-negative cancer.
排除标准
- •metastatic cancer
- •other primary tumours
- •disability preventing a proper understanding of the instructions for the trial
- •chemotherapy strictly contra-indicated
- •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.
结局指标
主要结局
main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
时间窗: 27 weeks
次要结局
- Assessment at 27 and 54 weeks between the 2 groups of muscle function.(54 weeks)