Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Overall exercise capacity
研究概览
简要总结
The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. If exercise may be an effective preventive strategy, it seems important to prescribe the most efficient exercise modality. Among them, concentric cycling (i.e., classic cycling) can significantly induce metabolic stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to demonstrate the superiority of a training program based on concentric cycling during chemotherapy compared to standard treatment. The duration of the training program is 15 weeks with one session per week.
详细描述
There will be two groups of patients after drawing lots using a process called randomization. The probability is one in two of being in the group participating in the training program, the other group following the standard treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman ≥ 18 years old
- •Stage I to III breast cancer
- •Patient currently planning (neo)adjuvant treatment combining anthracycline-cyclophosphamide and weekly paclitaxel (± trastuzumab)
- •Affiliation to a social security system
- •Able to speak, read and understand French
排除标准
- •No prior chemotherapy treatment
- •Any known cardiac or vascular pathology
- •Contraindications to physical fitness assessment
- •Protected adult
- •Psychiatric, musculoskeletal or neurological problems
- •Pregnant or breastfeeding woman (NB: this population is already subject to a contraindication to (neo)adjuvant treatment. For women of childbearing age, a betaHCG dosage is already carried out systematically before the start of chemotherapy and information on the need for contraception throughout the chemotherapy period is provided before the start of treatment. As part of this study, only the presence of this test with a negative result at the start of chemotherapy will be checked. inclusion, if available).
研究组 & 干预措施
Training group
This group of patients will perform concentric cycling training program during the chemotherapy treatment.
干预措施: Training sessions (Procedure)
Control group
This group of patients will benefit from standard care without additional training program.
结局指标
主要结局
Overall exercise capacity
时间窗: At week 18 (the end of chemotherapy treatment)
To investigate the superiority of a concentric pedaling training program during (neo)adjuvant chemotherapy versus the absence of a training program in patients with early breast cancer. The overall exercise capacity is assessed by the 6-minute walk test (TDM6) between the two groups.
次要结局
- Physiological variables associated with exercise capacity - muscle function(At week 18 (the end of chemotherapy treatment))
- Psychosocial variables associated with exercise capacity - appetite level(At week 18 (the end of chemotherapy treatment))
- Psychosocial variables associated with exercise capacity - quality of life(At week 18 (the end of chemotherapy treatment))
- Physiological variables associated with exercise capacity - cardiorespiratory capacity(At week 18 (the end of chemotherapy treatment))
- Psychosocial variables associated with exercise capacity - fatigue(At week 18 (the end of chemotherapy treatment))
- Physiological variables associated with exercise capacity - body composition(At week 18 (the end of chemotherapy treatment))
- Physiological variables associated with exercise capacity - cardiorespiratory capacity(At weeks 8.)
- Physiological variables associated with exercise capacity - muscle architecture(At week 18 (the end of chemotherapy treatment))
- Physiological variables associated with exercise capacity - muscle function(At weeks 8.)
- Physiological variables associated with exercise capacity - body composition(At weeks 8.)
- Physiological variables associated with exercise capacity - muscle architecture(At weeks 8.)
- Psychosocial variables associated with exercise capacity - quality of life(At weeks 8.)
- Psychosocial variables associated with exercise capacity - fatigue(At weeks 8.)
- Psychosocial variables associated with exercise capacity - appetite level(At weeks 8.)