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临床试验/NCT02796365
NCT02796365已完成不适用

Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Left ventricular strain

研究概览

简要总结

The purpose of this study is to identify patients at risk for future heart failure using novel markers of early cardiac damage and determine if exercise training can improve these emerging markers as well as overall fitness and quality of life.

详细描述

With more than 14 million cancer survivors in the United States, more patients than ever are living well beyond their initial cancer diagnosis. However despite the tremendous progress, cancer treatments often come with adverse side-effects, perhaps none are more serious or devastating than chemotherapy induced heart failure.

In many patients, the clinical manifestation of heart failure may not appear until a year, or several years, after completion of chemotherapy. While an echocardiogram is part of standardized surveillance for patients on these drugs, current echocardiogram parameters may not be sensitive enough to quickly detect early heart damage which, in some cases, is irreversible.

Unfortunately, even if detected early, there is no uniformity in terms of how to best treat patients with subclinical cardiac dysfunction who are at risk for heart failure. The use of certain blood pressure drugs show promise, especially in patients with hypertension. However, in addition to drug side-effects (e.g. dizziness/lightheadedness), they do not target the underlying mechanism of chemotherapy induced cardiotoxicity.

Exercise, in various forms, has shown promise in animal studies as a potential cardio-protective therapy to counteract drug toxicity. In general, exercise has many pleiotropic effects for patients receiving chemotherapy (e.g. reduces fatigue, improves endurance, reduces frailty, and enhances quality of life). Relative to DOX toxicity, research involving animals has also shown that exercise protects against deleterious heart dysfunction while showing an enhancement of potential mechanisms involved in chemotherapy induced heart failure (i.e. anti-oxidant and anti-apoptosis pathways).

Patients with cancer who receive either doxorubicin (DOX) or trastuzumab will be screened by one of two methods: 1) a strain echo or 2) a high sensitivity troponin. If either test is positive, patients will meet with a board-certified cardiologist who will determine if the patient may participate in the exercise trial. Under the supervision of a trained clinical exercise physiologist patients will undergo baseline testing, which includes: a quality of life assessment via questionaires, a body composition test, cardiopulmonary stress test and a muscle strength test. These assessment will be performed at baseline and at 12 weeks. Also performed at 12 weeks will be a repeat strain echo and high sensitivity troponin.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cancer who are undergoing or have completed the chemotherapy drugs doxorubicin and/or trastuzumab.
  • Have had a recent echocardiogram with a relative reduction in LV strain of >10%.
  • If no recent echocardiogram, have a troponin value >0.04 ng/mL, or an increase of 0.04 ng/mL if baseline troponin is elevated.
  • Age >/= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) scale 0-
  • Males and females.

排除标准

  • Patients with an Ejection Fraction <50%
  • Patients not deemed appropriate by a cardiologist or oncologist
  • Patients with an ECOG scale >2
  • Inability to perform exercise
  • Patients who already report exercising >2days per week for >29 minutes

结局指标

主要结局

Left ventricular strain

时间窗: 12 weeks

Spectral Doppler measure with General Electric software analysis of global longitudinal strain.

次要结局

  • Percent body fat(12 weeks)
  • Quality of life(12 weeks)
  • Isokinetic strength(12 weeks)
  • Cardiac Troponin(12 weeks)
  • Peak VO2(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis J. Kerrigan

Bioscientific Staff

Henry Ford Health System

研究点 (2)

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