Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy
Condition: Doxorubicin Induced Cardiomyopathy; Breast Cancer; Gastric Cancer; Leukemia
MeSH terms: Cardiomyopathies; Cardiotoxicity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Following baseline testing patients will be randomized into exercise training versus standard
      care. The exercise training will include 12 weeks of cardiac rehabilitation which can be
      offered in Detroit, Livonia, or West Bloomfield. Exercise will consist of 3 days per week of
      an interval training aerobic exercise on a treadmill and/or bike for 30-60 minutes and 1-2
      days per week of an individualized resistance training program.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Intervention will include 10 weeks of a standard cardiac rehabilitation program consisting of thrice a week aerobic exercise and 1-2 days per week resistance exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise; Cancer; Cardiotoxicity; Cardiomyopathy; Cardiac Rehabilitation