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NCT Number: NCT06455904

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux civils de Colmar, Colmar, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Training sessions

Procedure

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

Primary outcomes

  1. Overall exercise capacity

    Time frame: 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 outcomes

  1. Physiological variables associated with exercise capacity - cardiorespiratory capacity

    Time frame: At weeks 8.

    To examine the effects of the training program on VO2max.

  2. Physiological variables associated with exercise capacity - cardiorespiratory capacity

    Time frame: At week 18 (the end of chemotherapy treatment)

    To examine the effects of the training program on VO2max.

  3. Physiological variables associated with exercise capacity - muscle function

    Time frame: At weeks 8.

    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.

  4. Physiological variables associated with exercise capacity - muscle function

    Time frame: 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.

  5. Physiological variables associated with exercise capacity - body composition

    Time frame: At weeks 8.

    To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry.

  6. Physiological variables associated with exercise capacity - body composition

    Time frame: 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.

  7. Physiological variables associated with exercise capacity - muscle architecture

    Time frame: At weeks 8.

    To examine the effects of the training program on muscle thickness assessed by ultrasonography.

  8. Physiological variables associated with exercise capacity - muscle architecture

    Time frame: At weeks 8.

    To examine the effects of the training program on fascicle length assessed by ultrasonography.

  9. Physiological variables associated with exercise capacity - muscle architecture

    Time frame: At weeks 8.

    To examine the effects of the training program on cross-sectional area assessed by ultrasonography.

  10. Physiological variables associated with exercise capacity - muscle architecture

    Time frame: At week 18 (the end of chemotherapy treatment)

    To examine the effects of the training program on muscle thickness assessed by ultrasonography.

  11. Physiological variables associated with exercise capacity - muscle architecture

    Time frame: At week 18 (the end of chemotherapy treatment)

    To examine the effects of the training program on fascicle length assessed by ultrasonography.

  12. Physiological variables associated with exercise capacity - muscle architecture

    Time frame: At week 18 (the end of chemotherapy treatment)

    To examine the effects of the training program on cross-sectional area assessed by ultrasonography.

  13. Psychosocial variables associated with exercise capacity - quality of life

    Time frame: At weeks 8.

    To examine the effects of the training program with the FACT-G questionnaire

  14. Psychosocial variables associated with exercise capacity - quality of life

    Time frame: At week 18 (the end of chemotherapy treatment)

    To examine the effects of the training program with the FACT-G questionnaire

  15. Psychosocial variables associated with exercise capacity - fatigue

    Time frame: At weeks 8.

    To examine the effects of the training program with the FACIT-F questionnaire

  16. Psychosocial variables associated with exercise capacity - fatigue

    Time frame: At week 18 (the end of chemotherapy treatment)

    To examine the effects of the training program with the FACIT-F questionnaire

  17. Psychosocial variables associated with exercise capacity - appetite level

    Time frame: At weeks 8.

    To examine the effects of the training program with the FAACT questionnaire

  18. Psychosocial variables associated with exercise capacity - appetite level

    Time frame: At week 18 (the end of chemotherapy treatment)

    To examine the effects of the training program with the FAACT questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Joris MALLARD, PhD

CONTACT

[email protected]

368767419 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Acronym: PROTECT-07

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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