Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer - PROTECT-COEUR
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EC + Tax group
For the EC + Taxol arm, patients will have five visits during (neo)adjuvant chemotherapy: before the start of chemotherapy (evaluation 1), before the second EC administration (evaluation 2), before the third EC administration (evaluation 3), at the end of EC sessions and before the start of Tax (evaluation 4), and at the end of Tax administration (end of chemotherapy) (evaluation 5).
干预措施: Cardiac evaluation (Other)
Trastuzumab group
Patients in the Trastuzumab arm will be assessed only once at the end of treatment (on the same evaluation as the CE + Tax arm) to allow comparison with the fifth evaluation in the CE + Tax arm.
干预措施: Cardiac evaluation (Other)
结局指标
主要结局
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.
时间窗: During the treatment period, approximately 16 to 21 weeks
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.
次要结局
- 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.(During the treatment period, approximately 16 to 21 weeks)
- To compare myocardial deformations (at rest and under submaximal stress) between patients treated with EC + Tax to patients treated with trastuzumab.(During the treatment period, approximately 16 to 21 weeks)