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

NCT06455904 | Recruiting

• 1 other identifier: 2023-005
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Physiological variables associated with exercise capacity - cardiorespiratory capacity

  At weeks 8.

• Physiological variables associated with exercise capacity - cardiorespiratory capacity

  At week 18 (the end of chemotherapy treatment)

• Physiological variables associated with exercise capacity - muscle function

  At weeks 8.

• Physiological variables associated with exercise capacity - muscle function

  At week 18 (the end of chemotherapy treatment)

• Physiological variables associated with exercise capacity - body composition

  At weeks 8.

Study Arms (2)

Training group

EXPERIMENTAL

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

Procedure: Training sessions

Control group

NO INTERVENTION

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

Interventions

Training sessions PROCEDURE

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

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No prior chemotherapy treatment
• Any known cardiac or vascular pathology
• Contraindications to physical fitness assessment
• Protected adult
• Psychiatric, musculoskeletal or neurological problems

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (2)

Hôpitaux civils de Colmar

Colmar, 68024, France

NOT YET RECRUITING

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• BENDER Laura, MD

  Institut de cancérologie Strasbourg Europe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joris MALLARD, PhD

CONTACT

368767419; j.mallard@icans.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 12, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

FR (2)