Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
- Conditions
- Breast Cancer
- Interventions
- Procedure: Training sessions
- Registration Number
- NCT06455904
- Lead Sponsor
- Institut de cancérologie Strasbourg Europe
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 156
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training group Training sessions This group of patients will perform concentric cycling training program during the chemotherapy treatment.
- Primary Outcome Measures
Name Time Method Overall exercise capacity 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.
- Secondary Outcome Measures
Name Time Method Physiological variables associated with exercise capacity - muscle function At week 18 (the end of chemotherapy treatment) 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 architecture At week 18 (the end of chemotherapy treatment) To examine the effects of the training program on cross-sectional area assessed by ultrasonography.
Psychosocial variables associated with exercise capacity - appetite level At week 18 (the end of chemotherapy treatment) To examine the effects of the training program with the FAACT questionnaire
Psychosocial variables associated with exercise capacity - quality of life At week 18 (the end of chemotherapy treatment) To examine the effects of the training program with the FACT-G questionnaire
Physiological variables associated with exercise capacity - cardiorespiratory capacity At week 18 (the end of chemotherapy treatment) To examine the effects of the training program on VO2max.
Psychosocial variables associated with exercise capacity - fatigue At week 18 (the end of chemotherapy treatment) To examine the effects of the training program with the FACIT-F questionnaire
Physiological variables associated with exercise capacity - body composition At week 18 (the end of chemotherapy treatment) To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry.
Trial Locations
- Locations (2)
Hôpitaux civils de Colmar
🇫🇷Colmar, France
Institut de cancérologie Strasbourg Europe
🇫🇷Strasbourg, France