Concentric cycling training during chemotherapy for breast cancer patients
Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
This study tests if a special cycling program can help breast cancer patients feel better and stay stronger while they are going through chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Paul Strauss Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, cyclophosphamide |
| Locations | 2 sites (Colmar and 1 other locations) |
| Trial ID | NCT06455904 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a concentric cycling training program on breast cancer patients undergoing (neo)adjuvant chemotherapy. Patients will be randomly assigned to either a training group, which participates in weekly cycling sessions for 15 weeks, or a control group receiving standard treatment. The goal is to determine if this exercise modality can help maintain or improve physical condition and exercise capacity during chemotherapy. The study focuses on patients receiving a combination of anthracyclines and paclitaxel, which are known to cause significant side effects.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with stage I to III breast cancer who are about to start specific chemotherapy regimens.
Not a fit: Patients who have previously undergone chemotherapy or have significant cardiac, vascular, or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the physical well-being and quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have shown that exercise can mitigate chemotherapy side effects, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Colmar and 1 other locations
- Hôpitaux civils de Colmar — Colmar, France (Not_yet_recruiting)
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: BENDER Laura, MD — Institut de cancérologie Strasbourg Europe
- Study coordinator: Joris MALLARD, PhD
- Email: j.mallard@icans.eu
- Phone: 368767419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.