Aerobic Interval Exercise Preconditioning to Prevent Cardiometabolic and Neuropsychological Complications of Anthracycline Based Breast Cancer Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in left ventricular ejection fraction
研究概览
简要总结
The purpose of this study is to determine whether a supervised exercise-training program, initiated prior to chemotherapy induction (pre-conditioning) and continued throughout chemotherapy treatment, can preserve short- and long-term cardiovascular performance, skeletal muscle function, cognitive ability and quality of life better than current standard or care recommendations for exercise during chemotherapy.
详细描述
The primary aim of this study is to determine the efficacy of a novel, high-intensity aerobic interval exercise preconditioning protocol to ameliorate anthracycline-mediated cardiac and skeletal muscle toxicity in women with breast cancer undergoing de novo chemotherapy.
Research Design:
Women with breast cancer scheduled to undergo de novo chemotherapy with anthracyclines will be enrolled. Qualified patients will be randomized to either 1) a high-intensity interval exercise group, or 2) an attention-control group.
Supervised exercise training will be carried out at the Mayo Clinic Cardiac rehabilitation center in Arizona on cycle ergometers using Electrocardiogram (EKG) telemetry. Patients in the high-intensity interval exercise group will perform four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR.
The attention-controls will receive counseling consistent with standard of care regarding physical activity during chemotherapy. Attention-control group will receive a weekly phone call to maintain physical activity during chemotherapy and compliance will be verified using physical activity diaries and pedometers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
- •Subjects will have been recently diagnosed with breast cancer (stage I, II or III)
- •Subjects must be scheduled by their oncologist to undergo anthracycline based chemotherapy (doxorubicin and cyclophosphamide) in the neoadjuvant/adjuvant setting
排除标准
- •Unstable angina
- •Myocardial infarction in the past 4 weeks
- •Uncompensated heart failure
- •New York Heart Association class IV symptoms
- •Complex ventricular arrhythmias
- •Medical orthopedic conditions precluding stationary cycling
- •Medical conditions precluding neuropsychological assessment
- •Symptomatic severe aortic stenosis
- •Acute pulmonary embolus
- •Acute myocarditis
- •Untreated high-risk proliferative retinopathy
- •Recent retinal hemorrhage
- •Uncontrolled hypertension
- •Sodium and/or Potassium ≥ Grade 2
- •Pregnant Women
结局指标
主要结局
Change in left ventricular ejection fraction
时间窗: baseline, approximately 2 months
Echocardiography will be used to assess biventricular systolic function.
Change in diastolic function
时间窗: baseline, approximately 2 months
Echocardiography will be used to assess biventricular diastolic function.
次要结局
未报告次要终点