Clinical trial NCT05803889: Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer
Official title: Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer - PROTECT-COEUR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: UR 3072
First posted: 2023-04-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population composed of a group of breast cancer patients undergoing chemotherapy with EC and Tax, and a group of breath cancer patients undergoing Trastuzumab treatment.

Brief summary: The combination of epirubicin-cyclophosphamide (EC) and paclitaxel (Tax) is one of the main chemotherapy treatments used in breast cancer patients. These treatments, which can be combined with anti-HER2 therapy using trastuzumab, are frequently associated with side effects including cardiac toxicity. However, this cardiac toxicity has only been demonstrated several months after treatment and using global indices such as ejection fraction.

The assessment of myocardial dysfunction using regional deformations and the kinetic of this dysfunction during chemotherapy treatment has never been performed. In order to counteract these myocardial dysfunctions, it is essential to better describe the kinetic of the cardiac toxicity by initiating measurements since the beginning of the treatment, in order to be able to propose adapted countermeasures (e.g. exercise training) in parallel with the chemotherapy.


Eligibility 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

Primary outcomes:
measure: Studying the impact of chemotherapy combining EC and Tax on myocardial deformations (at rest and at submaximal effort) in order to identify the kinetic of systolic and diastolic dysfunctions.
timeFrame: During the treatment period, approximately 16 to 21 weeks
Secondary outcomes:
measure: Studying the kinetic of the development of vascular dysfunction in order to understand a potential vascular dysfunction that could occur during treatment with chemotherapy combining EC and Tax.
timeFrame: During the treatment period, approximately 16 to 21 weeks
measure: To compare myocardial deformations (at rest and under submaximal stress) between patients treated with EC + Tax to patients treated with trastuzumab.
timeFrame: During the treatment period, approximately 16 to 21 weeks
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References: