NCT05803889

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Institut de cancérologie Strasbourg Europe · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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).
OTHER	Cardiac evaluation	The same measurements as the EC + Tax group will be performed but only once, at the end of the treatment.

Timeline

• Start date: 2023-09-21
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2023-04-07
• Last updated: 2026-01-05

Locations

1 site across 1 country: France