Role of Aerobic Exercise to Modulate Cardiotoxicity in Long Term Cancer Survivors Exposed to Anthracycline Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Small increase in the left and right ventricular volume
研究概览
简要总结
Over 50% of the more than 270,000 childhood cancer survivors in the U.S. have been treated with anthracyclines and thus are at risk of developing cardiotoxicity. The impact of exercise training on LV structure has been extensively studied. Left ventricular hypertrophy and cardiac chamber enlargement with the accompanying ability to generate a large stroke volume are direct results of exercise training. Aerobic exercise therapy offers a non-pharmacological mechanism to modulate multiple gene expression pathways that may promote cardiac remodeling. No prior studies have investigated the efficacy of aerobic exercise in the prevention or treatment of anthracycline-induced cardiotoxicity. We hypothesize that exercise intervention leads to a reverse in adverse cardiac remodeling with improvement of global and regional myocardial function in patients exposed to anthracycline.
详细描述
The goal of this research is to assess the effect of exercise intervention on imaging parameters by CMR, cardiopulmonary indices and MicroRNA expression in survivors of childhood cancer exposed to anthracycline therapy. Thus, results from this study could provide a foundation for a paradigm shift in our approach to the prevention and management of anthracycline induced cardiotoxicity in this population. Patients who have been exposed to anthracycline treatment and who are greater than 9 years of age will be enrolled.
Patients will come into the clinic for 7 study visits. Patients will have an exercise intervention provided to them by a trainer at the designated YMCA. Patients will start their exercise for 15 minutes per day for 3-5 days a week for week one progressing to 45 minutes per day, 3 - 5 days a week as tolerated by the end of week four. The goal during each session is for the patient to exercise at 50-80% of their age adjusted maximum heart rate, which will be determined by the personal trainer (PT) at their initial visit. The exercise program will continue for 12 weeks (ending at 16 weeks after entry to the study).
In the clinic patients will have the following tests completed:
Week 0 and Week 16: Cardiac MRI, stress test along with blood samples and Karnofsky/Lansky Scale.
Week 0 patients receive a Fitbit and home diary/Wellness Log for completion. Week 4 began exercise intervention Weeks 0, 4, 8, 16 and 20 patients will receive phone calls for symptom tracker Weeks 0, 16, and 6 month f/u patients complete a questionnaire
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long-term childhood cancer survivors greater than 9 years of age*
- •Exposed to anthracycline chemotherapy * Age > 9 years of age was chosen to avoid the need for general anesthesia or sedation
排除标准
- •Contraindications to CMRI*
- •Individuals needing sedation to complete the cMRI
- •Subject not able to perform stress test.
- •Pregnancy**
- •Non-English speaking individuals
- •Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye
结局指标
主要结局
Small increase in the left and right ventricular volume
时间窗: Baseline to Week 12
Small increase in the left and right ventricular volume
Small increase in left and right ventricular mass
时间窗: Baseline to Week 12
Small increase in left and right ventricular mass
次要结局
未报告次要终点
研究者
Tiffany Ruiz
Cardio-oncology nurse program manager
Connecticut Children's Medical Center