NCT06455904 Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
| NCT ID | NCT06455904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Paul Strauss |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2027-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 156 participants in total. It began in 2024-05-30 with a primary completion date of 2027-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
BENDER Laura, MD
PRINCIPAL INVESTIGATOR
Institut de cancérologie Strasbourg Europe
Frequently Asked Questions
Who can join the NCT06455904 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06455904 currently recruiting?
Yes, NCT06455904 is actively recruiting participants. Contact the research team at j.mallard@icans.eu for enrollment information.
Where is the NCT06455904 trial being conducted?
This trial is being conducted at Colmar, France, Strasbourg, France.
Who is sponsoring the NCT06455904 clinical trial?
NCT06455904 is sponsored by Centre Paul Strauss. The principal investigator is BENDER Laura, MD at Institut de cancérologie Strasbourg Europe. The trial plans to enroll 156 participants.
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