The Effects of Short-term Exercise or Caloric Restriction on Anthracycline Chemotherapy-related Treatment Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in left ventricular ejection fraction reserve (peak exercise - rest)
研究概览
简要总结
Doxorubicin and epirubicin are part of the class of chemotherapy agents called anthracyclines that are commonly used to treat breast cancer. Although these treatments work well against the tumor, they are known to cause damage to the heart muscle, resulting in diminished heart function that can be permanent, and may also damage the blood vessels and skeletal muscles. The purpose of this study is to determine whether short-term application of these interventions with specific timing relative to the receipt of each treatment can prevent the negative effects of anthracycline treatment on the heart, aorta (largest artery leaving the heart), and skeletal muscle, and reduce treatment symptoms. Fifty-six early stage breast cancer patients who will receive anthracycline treatment will be randomly assigned to 1 of 3 groups who will: 1) perform a single 30-minute aerobic exercise session 24 hours prior to each treatment; 2) eat a diet consisting of 50% less calories for 48 hours prior to each treatment; or 3) receive usual cancer care. Magnetic resonance imaging (MRI) will be used to precisely measure the function of the heart, aorta, and the lower leg skeletal muscle at rest, and again during exercise to allow detection of more subtle signs of damage. We will also measure exercise capacity (i.e. aerobic fitness), microscopic damage to the heart muscle cells, a marker released into the blood in response to anthracycline-related heart damage, tumor size in patients receiving chemotherapy before surgery, quality of life and fatigue. These measures will be performed before treatment, at the end of treatment and 1 year later.
详细描述
Research Question: Is there a practical, widely available, non-pharmacological intervention that can be used to reduce the detrimental effects of anthracycline treatment to improve breast cancer patient cardiovascular health, well-being?
Primary Hypothesis: short-term application of aerobic exercise or caloric restriction prior to anthracycline chemotherapy treatments for breast cancer will reduce the detrimental effects of anthracyclines on heart, vessels and skeletal muscle.
Exploratory Hypothesis: these interventions will enhance the anticancer effects of anthracyclines and/or reduce the detrimental effects of anthracyclines on health-related quality of life.
Primary Study Aims: to investigate the effect of a single aerobic exercise session performed 24 hours prior to anthracycline treatment and the effect of 50% caloric restriction for 48 hours prior to anthracycline treatment relative to usual care control. Specifically, we will measure the intervention effects on:
I) Cardiac structure and function: 1) circulating NT-proBNP (interventions will mitigate unwanted increase in this prognostic marker of development of later cardiotoxicity); 2) left ventricular ejection fraction reserve (interventions will mitigate unwanted reduction in ability to augment heart function with exercise challenge) and 3) cardiac T1 mapping (interventions will mitigate unwanted increase in this marker of formation of myocardial fibrosis)
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
- Double (Care Provider, Outcomes Assessor)
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
- •stage I-IIIC breast cancer
- •scheduled to receive an anthracycline-containing chemotherapy protocol
- •able to read and communicate in English
- •willing and able to adhere to either intervention
排除标准
- •contraindications to MRI (e.g. pacemakers, metal implants)
- •contraindications to maximal exercise testing
- •have orthopedic limitations to sustained exercise on all potential modes (treadmill, elliptical, bike)
- •have a body mass index <19 kg/m2
- •history of eating disorder (self- or oncologist-reported)
- •severe food allergies or restrictions
结局指标
主要结局
Change in left ventricular ejection fraction reserve (peak exercise - rest)
时间窗: 3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment
Cine steady-state free precession 2- and 4- chamber images will be taken at rest and at peak exercise using a resisted stepping device with a 3 T MRI scanner
次要结局
- Change in NT-proBNP(3-14 days before first anthracycline treatment, 24 hours after 1st and last anthracycline treatments, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in aortic distensibility(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in skeletal muscle oxygen extraction reserve (peak exercise - rest)(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in skeletal muscle oxygen consumption reserve (peak exercise - rest)(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in peak exercise LV strain(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in resting LV strain(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in cardiac T1(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in peak LVEF(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Patient-reported treatment symptoms(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in cardiac output(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in LV volumes(Cine steady-state free precession will be taken at rest and peak exercise to quantify volumes and will be multiplied by heart rate to determine cardiac output)
- Change in LV mass(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in resting LVEF(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in thigh skeletal muscle mass and quality(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)
- Change in peak oxygen consumption(3-14 days before first anthracycline treatment, 2-3 weeks after completion of anthracycline treatment, one year after initiation of anthracycline treatment)