About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No prior chemotherapy treatment
Any known cardiac or vascular pathology
Contraindications to physical fitness assessment
Protected adult
Trial design
Parallel
Treatments tested in this trial
Training sessions
Procedure/SurgeryThe training program will be performed during 15 weeks, with one session per week.
Treatment groups
Trial outcomes
Primary outcomes
Overall exercise capacity
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.
Secondary outcomes
Physiological variables associated with exercise capacity - cardiorespiratory capacity
To examine the effects of the training program on VO2max.
Physiological variables associated with exercise capacity - cardiorespiratory capacity
To examine the effects of the training program on VO2max.
Physiological variables associated with exercise capacity - muscle function
To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test.
Physiological variables associated with exercise capacity - muscle function
To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test.
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