Understanding heart issues caused by chemotherapy in breast cancer patients
Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer - PROTECT-COEUR
This study looks at heart problems caused by certain chemotherapy drugs in women with breast cancer to see if early detection can help find ways to reduce these side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut de cancérologie Strasbourg Europe Academic / other |
| Drugs / interventions | Trastuzumab, cyclophosphamide, chemotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05803889 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the cardiovascular toxicity associated with the chemotherapy regimen of epirubicin-cyclophosphamide and paclitaxel in breast cancer patients. It aims to assess myocardial dysfunction using advanced techniques to measure regional deformations and track the progression of cardiac toxicity from the start of treatment. By identifying these issues early, the study seeks to propose tailored countermeasures, such as exercise training, to mitigate the cardiac side effects during chemotherapy. The research will involve female patients aged 18 and older who are undergoing specific chemotherapy treatments.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with stage I to III breast cancer who are scheduled to receive specific chemotherapy regimens.
Not a fit: Patients with contraindications to exercise, psychiatric or neurological issues, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cardiac side effects in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While studies have explored chemotherapy-related cardiac toxicity, this specific approach of early kinetic assessment and intervention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Epirubicin-cyclophosphamide + paclitaxel group: * Female ≥ 18 years * Stage I to III breast cancer * Patient being planned for (neo)adjuvant therapy combining EC and Taxol on a weekly basis * Enrolled in a social security plan * Able to speak, read and understand French Trastuzumab group: * Female ≥ 18 years of age * Stage I to III breast cancer * Patient treated with trastuzumab * Enrolled in a social security plan * Able to speak, read and understand French Exclusion Criteria: For both groups: Epirubicin-cyclophosphamid + paclitaxel group and trastuzumab group * Implantation of a pacemaker * Contraindications to exercise * Protected adult * Psychiatric, musculoskeletal or neurological problems * Pregnant or breastfeeding woman * Uncontrolled high blood pressure * Body Mass Index \> 35 kg/m²
Where this trial is running
Strasbourg
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Manon VOEGELIN
- Email: promotion-rc@icans.eu
- Phone: 368767360
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.