Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
NCT Number: NCT06455904
Acronym: PROTECT-07
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: PROCEDURE: Training sessions
Sponsor: Institut de cancérologie Strasbourg Europe
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-05-30
Completion Date: 2027-01-13
Locations: Hôpitaux civils de Colmar, Colmar, 68024, France|Institut de cancérologie Strasbourg Europe, Strasbourg, 67033, France

Summary:
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.

Primary Outcome Measures: 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., At week 18 (the end of chemotherapy treatment)
Secondary Outcome Measures: Physiological variables associated with exercise capacity - cardiorespiratory capacity, To examine the effects of the training program on VO2max., At weeks 8.|Physiological variables associated with exercise capacity - cardiorespiratory capacity, To examine the effects of the training program on VO2max., At week 18 (the end of chemotherapy treatment)|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., At weeks 8.|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., At week 18 (the end of chemotherapy treatment)|Physiological variables associated with exercise capacity - body composition, To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry., At weeks 8.|Physiological variables associated with exercise capacity - body composition, To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry., At week 18 (the end of chemotherapy treatment)|Physiological variables associated with exercise capacity - muscle architecture, To examine the effects of the training program on muscle thickness assessed by ultrasonography., At weeks 8.|Physiological variables associated with exercise capacity - muscle architecture, To examine the effects of the training program on fascicle length assessed by ultrasonography., At weeks 8.|Physiological variables associated with exercise capacity - muscle architecture, To examine the effects of the training program on cross-sectional area assessed by ultrasonography., At weeks 8.|Physiological variables associated with exercise capacity - muscle architecture, To examine the effects of the training program on muscle thickness assessed by ultrasonography., At week 18 (the end of chemotherapy treatment)|Physiological variables associated with exercise capacity - muscle architecture, To examine the effects of the training program on fascicle length assessed by ultrasonography., At week 18 (the end of chemotherapy treatment)|Physiological variables associated with exercise capacity - muscle architecture, To examine the effects of the training program on cross-sectional area assessed by ultrasonography., At week 18 (the end of chemotherapy treatment)|Psychosocial variables associated with exercise capacity - quality of life, To examine the effects of the training program with the FACT-G questionnaire, At weeks 8.|Psychosocial variables associated with exercise capacity - quality of life, To examine the effects of the training program with the FACT-G questionnaire, At week 18 (the end of chemotherapy treatment)|Psychosocial variables associated with exercise capacity - fatigue, To examine the effects of the training program with the FACIT-F questionnaire, At weeks 8.|Psychosocial variables associated with exercise capacity - fatigue, To examine the effects of the training program with the FACIT-F questionnaire, At week 18 (the end of chemotherapy treatment)|Psychosocial variables associated with exercise capacity - appetite level, To examine the effects of the training program with the FAACT questionnaire, At weeks 8.|Psychosocial variables associated with exercise capacity - appetite level, To examine the effects of the training program with the FAACT questionnaire, At week 18 (the end of chemotherapy treatment)