Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study
Condition: Neoplasms; Heart; Disease, Functional; Inflammation
MeSH terms: Cardiotoxicity; Inflammation
Study type: Interventional

Summary: 
      As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are
      becoming increasingly apparent. Most prominent are the toxic effects on the heart
      (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular
      disease (CVD). The investigators hypothesize that an individualized aerobic training program
      for cancer patients receiving active treatment will be both feasible and safe and will result
      in improvements in overall levels of physical activity and quality of life.

      Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates,
      along with program safety. Efficacy will be assessed by evaluating changes in health-related
      outcomes.
    

Detailed description: 
      As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are
      becoming increasingly apparent. Most prominent are the toxic effects on the heart
      (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular
      disease (CVD). Of note, data indicate that the magnitude of CVD risk for long-term survivors
      may exceed the risk of a secondary malignancy, which is a known complication of primary
      cancer therapy. While long-term follow-up data in adult cancer survivors is lacking, study of
      adult survivors of childhood cancers shows that these individuals are 15 times more likely to
      develop congestive heart failure (CHF), 10 times more likely to develop CVD, and 9 times more
      likely to suffer a stroke compared individuals who have not had cancer. Thus, it is clear
      that the long-term cardiotoxic effects of cancer therapy represent a significant concern for
      cancer survivors. The mechanisms responsible for the damaging effects of cancer therapy are
      not fully understood, however there is a need to maximize the benefits of treatment while
      minimizing long-term damage. Recent animal studies suggest that aerobic exercise training may
      offer a protective effect against chemotherapy-induced heart disease. However, to the
      investigator's knowledge, no study to date has examined the potential cardioprotective
      benefits of exercise training for patients receiving cancer treatment.

      Accordingly, the purpose of this pilot study is to evaluate the feasibility and efficacy of a
      12-week supervised exercise program based on the principles of cardiac rehabilitation for
      patients receiving anthracycline-based chemotherapy.

      Feasibility will be assessed by evaluating three outcomes, recruitment rate, adherence rate
      (i.e. exercise class attendance records), attrition rate, and safety (i.e. number of adverse
      events).

      Efficacy will be assessed by evaluating changes in health-related outcomes to assess if these
      changes are equal to or better than what was measured at baseline. The health-related
      outcomes include cardiac function and biological markers of cardiotoxicity.
    

Intervention name(s): Moderate Intensity Exercise
Intervention type(s): Other
Intervention description(s): Exercise sessions will be held twice-weekly and will begin with a group warm-up activity, followed by 45 minutes of aerobic activity and ending with a cool down. All aerobic exercise will be performed at a moderate intensity, defined as exercise that elicits a heart rate (HR) between 40-60% of heart rate reserve (HRR). Prior to the initial exercise session target heart rates will be calculated for each subject based on the maximum HR achieved during their baseline stress test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Quality of Life; Complementary Therapies; Neoadjuvant Therapy; Feasibility Studies