Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2027-01-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Training group

This group of patients will perform concentric cycling training program during the chemotherapy treatment.

Group Type EXPERIMENTAL

Training sessions

Intervention Type PROCEDURE

The training program will be performed during 15 weeks, with one session per week.

Control group

This group of patients will benefit from standard care without additional training program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Training sessions

The training program will be performed during 15 weeks, with one session per week.

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No