CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- V02 peak before and after chemotherapy
研究概览
简要总结
RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health.
PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.
详细描述
OBJECTIVES:
- To determine if patients with cancer can exercise safely and routinely, under supervision, while receiving anthracycline chemotherapy.
- To determine the magnitude of the change in the peak ventilatory oxygen uptake (VO2) before and after completion of anthracycline chemotherapy with concurrent exercise versus without exercise in patients with cancer.
OUTLINE: Patients are randomized to 1 of 2 intervention arms.
- Arm I (exercise): Patients undergo supervised aerobic exercise (walk or bicycle) 3 days a week concurrently with standard anthracycline-based chemotherapy for approximately 18-24 weeks.
- Arm II (non-exercise): Patients receive standard anthracycline-based chemotherapy for approximately 18-24 weeks.
Patients undergo peak ventilatory oxygen uptake (VO_2) by exercise bike test with gas exchange analysis at baseline and at 2 weeks after completion of anthracycline-based chemotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Patients with cancer scheduled to receive 4-6 courses of an anthracycline-based chemotherapy
- •PATIENT CHARACTERISTICS:
- •Able to pedal a stationary bicycle
- •No severe hypertension (systolic blood pressure > 220 mm Hg or diastolic blood pressure >120 mm Hg)
- •No atrial fibrillation with an uncontrolled ventricular response
- •No ventricular arrhythmias
- •No unstable angina
- •No acute myocardial infarction within the past 28 days of enrollment
- •No severe valvular heart disease
- •No severe (exercise-limiting) peripheral vascular disease
- •No severe pulmonary disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
standard of care
normal anthracycline therapy
exercise program
干预措施: exercise intervention (Behavioral)
结局指标
主要结局
V02 peak before and after chemotherapy
时间窗: 24 weeks
Percentage of patients enrolling in the study
时间窗: day 1
Percentage of patients completing the study
时间窗: 24 weeks
次要结局
未报告次要终点