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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Training sessions

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joris MALLARD, PhD; Phone Number: +33 368767419; Email: j.mallard@icans.eu

Study Locations

• France
  • Colmar, France, 68024
    • Not yet recruiting
    • Hôpitaux Civils de Colmar
    • Principal Investigator: Jean-Marc LIMACHER, MD
    • Contact: Manon VOEGELIN
  • Strasbourg, France, 67033
    • Recruiting
    • Institut de Cancérologie Strasbourg Europe
    • Contact: Manon VOEGELIN, PhD; Phone Number: +33 368339523; Email: promotion-rc@icans.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group; This group of patients will perform concentric cycling training program during the chemotherapy treatment.	Procedure: Training sessions; The training program will be performed during 15 weeks, with one session per week.
No Intervention: Control group; This group of patients will benefit from standard care without additional training program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Centre Paul Strauss
• Investigators: Principal Investigator: BENDER Laura, MD, Institut de Cancérologie Strasbourg Europe

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2023-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No