All-extremity Exercise as a Novel Strategy for Optimizing Cardiovascular Function During Chemotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in brachial artery FMD
研究概览
简要总结
Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
- •18 to 85 years of age
- •Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
- •Absence of contraindications to exercise
- •Study clinician approval
- •Able to give consent
- •Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process
排除标准
- •Do not meet inclusion criteria
- •Receiving targeted therapies (CDK4/6 or PARP inhibitors)
- •Receiving radiation therapy concurrent with chemotherapy
- •Lymphedema stage ≥ 2 prior to study enrollment
- •Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
- •Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
结局指标
主要结局
Change in brachial artery FMD
时间窗: 12 weeks
Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia.
Change in global longitudinal strain
时间窗: 12 weeks
Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction.
Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy
时间窗: Monitored throughout the 12 weeks of intervention
To evaluate the feasibility, tolerability and safety of all-extremity exercise compared with treadmill exercise in breast cancer patients undergoing chemotherapy, we will collect comprehensive information throughout the exercise intervention: completed vs. planned exercise dose (intensity/session, min/session, sessions/week), reasons for missed/partially completed sessions or study withdrawal, adverse events, and disease- and treatment-related outcomes. To specifically evaluate safety, should an adverse event occur, plans are in place for determination and monitoring according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions.
次要结局
未报告次要终点