Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer

Breast Cancer Clinical Trial

— PROTECT-COEUR  

Official title:

Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer - PROTECT-COEUR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803889
• Other study ID #: 2022-017
• Status: Recruiting
• Start date: September 21, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Manon VOEGELIN
• Phone: 368767360
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Cardiac evaluation
In order to obtain information on the body composition of the patients, a body composition measurement will be performed. A resting cardiac echocardiography will be performed to record myocardial deformations in a non-vulnerable way. A non-invasive evaluation of arterial function will be performed by ultrasound on the femoral artery during a standardized passive movement of the leg. An assessment of myocardial deformations will also be performed under submaximal exercise conditions (at a target heart rate of 120 beats per minute, low to moderate exercise intensity). All of these measurements will be performed during evaluation 1 and reproduced in the same way during the 4 other sessions planned during (evaluation 2, 3 and 4) and after the treatment (evaluation 5).
• Cardiac evaluation
The same measurements as the EC + Tax group will be performed but only once, at the end of the treatment.

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	UR 3072

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Characterizing the alteration of global longitudinal strain (GLS) by resting echocardiography at rest before, during, and after chemotherapy in a group of breast cancer patients receiving EC and Tax.	During the treatment period, approximately 16 to 21 weeks
Secondary	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.	Analyze changes in myocardial deformations during submaximal exercise, vascular function assessed non-invasively by femoral artery ultrasound, and changes in the presence of markers of myocardial injury in the blood compartment.	During the treatment period, approximately 16 to 21 weeks
Secondary	To compare myocardial deformations (at rest and under submaximal stress) between patients treated with EC + Tax to patients treated with trastuzumab.	Comparison of myocardial deformations changes induced by two types of treatment: EC + Tax and Trastuzumab. For this endpoint, we will compare the end of chemotherapy treatment to the end of trastuzumab treatment.	During the treatment period, approximately 16 to 21 weeks