Clinical trial NCT06455904: Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
Official title: Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an interventional, randomized controlled, prospective, multicenter and adaptive study aimed at investigating the effect of a concentric pedaling training program carried out during (neo)adjuvant chemotherapy in addition to usual care.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Overall exercise capacity
timeFrame: At week 18 (the end of chemotherapy treatment)
Secondary outcomes:
measure: Physiological variables associated with exercise capacity - cardiorespiratory capacity
timeFrame: At weeks 8.
measure: Physiological variables associated with exercise capacity - cardiorespiratory capacity
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Physiological variables associated with exercise capacity - muscle function
timeFrame: At weeks 8.
measure: Physiological variables associated with exercise capacity - muscle function
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Physiological variables associated with exercise capacity - body composition
timeFrame: At weeks 8.
measure: Physiological variables associated with exercise capacity - body composition
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Physiological variables associated with exercise capacity - muscle architecture
timeFrame: At weeks 8.
measure: Physiological variables associated with exercise capacity - muscle architecture
timeFrame: At weeks 8.
measure: Physiological variables associated with exercise capacity - muscle architecture
timeFrame: At weeks 8.
measure: Physiological variables associated with exercise capacity - muscle architecture
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Physiological variables associated with exercise capacity - muscle architecture
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Physiological variables associated with exercise capacity - muscle architecture
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Psychosocial variables associated with exercise capacity - quality of life
timeFrame: At weeks 8.
measure: Psychosocial variables associated with exercise capacity - quality of life
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Psychosocial variables associated with exercise capacity - fatigue
timeFrame: At weeks 8.
measure: Psychosocial variables associated with exercise capacity - fatigue
timeFrame: At week 18 (the end of chemotherapy treatment)
measure: Psychosocial variables associated with exercise capacity - appetite level
timeFrame: At weeks 8.
measure: Psychosocial variables associated with exercise capacity - appetite level
timeFrame: At week 18 (the end of chemotherapy treatment)
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hôpitaux civils de Colmar
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
affiliation: Institut de cancérologie Strasbourg Europe
name: BENDER Laura, MD
role: PRINCIPAL_INVESTIGATOR
References: