Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- NT-proBNP
研究概览
简要总结
Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP).
Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Woman with non-metastatic breast cancer not previously treated.
- •Scheduled to receive neoadjuvant doxorubicin chemotherapy.
- •Receive the oncologist´s approval for the practice of exercise.
- •Acceptance of randomization.
- •To sign an informed consent form before starting any measurement or procedure related to the project.
排除标准
- •Patients who receive initial surgery and who are not going to receive neoadjuvant treatment.
- •Contraindications to perform stress tests following the recommendations of the American Thoracic Society.
- •Pre-existing cardiovascular disease.
- •Body mass index (BMI) > 35 kg/m
- •Diabetes mellitus.
- •Renal disease.
- •Severe anemia.
- •Pregnacy.
- •Current smoking status.
结局指标
主要结局
NT-proBNP
时间窗: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Biomarker of cardiac injury value in blood tests
次要结局
- Blood Pressure(24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment)
- Cardiac Troponin I(24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment)
- Left Ventricular Ejection Fraction (LVEF)(0-14 days prior to the first treatment ( according to the usual clinical practice) and in the follow-up period (6 months after completion of the anthracycline treatment).)
研究者
Alejandro San Juan Ferrer
PhD Physical Activity and Health
Technical University of Madrid