Understanding Exercise Intolerance After Treatment for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- A-VO2 differences
研究概览
简要总结
This pilot research trial studies magnetic resonance imaging (MRI) and cardio (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients with stage I-III breast cancer after treatment with chemotherapy drugs called anthracyclines. Anthracyclines are related with heart problems, cardiac abnormalities, bone and muscle dysfunction. Patients with breast cancer who are exposed to anthracycline drugs may also experience progressive fatigue and exercise intolerance which may limit daily activities and is an important barrier for patients returning to work. Using MRI and cardio-pulmonary exercise testing (CPET) may help doctors understand the causes of fatigue and exercise intolerance in patients receiving anthracycline chemotherapy and this may also allow doctors to plan better treatments to protect patients' heart, cardiovascular system, bone and muscle function.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of performing upright treadmill cardio-pulmonary exercise stress testing utilizing magnetic resonance imaging.
II. To determine the reproducibility of measures of peak oxygen uptake (V02) and cardiac output as well as arterio-venous oxygen difference (A-V02) difference in survivors of breast cancer treatment and control participants.
OUTLINE:
Patients undergo CPET using a one-way breathing mask in 2 separate days 1-2 weeks apart. Patients also undergo MRI before and within 60 seconds after exercising.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with stage I-III breast cancer who began their cancer treatment 1-2 years prior to this study and have received anthracycline based chemotherapy
- •Women matched to age with our 16 post-cancer treatment participants
排除标准
- •Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
- •Those with contraindications for exercise tolerance test (ETT) testing, including unstable angina or inability to exercise on a treadmill or stationary cycle
- •Those who are pregnant, claustrophobic, or unable to provide informed consent
结局指标
主要结局
A-VO2 differences
时间窗: Baseline to up to 2 weeks
Descriptive statistics will be estimated for each measure at each of the two times they are measured. Correlation between the two assessments of each measure will be estimated and then establish a 95% confidence interval for this correlation. Difference between each assessment will be calculated and a 95% confidence interval for this difference will be estimated. A paired t-test will be performed to determine if the groups have a mean difference close to zero. The ratio of the variances for each measure at each time point will be examined. The ratio will be examined whether it is close to 1.0
次要结局
未报告次要终点