Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study
- Conditions
- InflammationNeoplasmsHeart; Disease, Functional
- Interventions
- Other: Moderate Intensity Exercise
- Registration Number
- NCT02471053
- Lead Sponsor
- Nova Scotia Health Authority
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
- Any patients who meet the inclusion criteria, but have any significant cognitive limitations will be excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Moderate Intensity Exercise Moderate Intensity Exercise All consenting patients will participate in an aerobic training program, twice-weekly over a 12-week period. Assessments will be performed at baseline (pre-training) and post-program (12-weeks). All participants will continue to receive standard care for their cancer diagnosis.
- Primary Outcome Measures
Name Time Method Feasibility as measured by rate of recruitment 12 Weeks The rate of recruitment will be measured by comparing the number of patients screened to the number of patients enrolled (patients per month).
Number of adverse events 12 Weeks The number of adverse events associated with exercise program will be used to examine safety.
- Secondary Outcome Measures
Name Time Method Cytokines (IL-1α) 12 Weeks Baseline and 12 week levels (picogram per milileter) will be compared.
Fasting Glucose 12 Weeks Baseline and 12 week levels will be compared.
Fatigue 12 Weeks The Functional Assessment of Cancer Therapy - Fatigue questionnaire will be used to compare baseline and 12 week self-reported levels of fatigue.
Lipid Profile 12 Weeks Baseline and 12 week levels will be compared.
Cardiac Disease Risk 12 Weeks Cardiac disease risk will be measured using the Framingham Risk Score.
Physical Activity Behaviours 12 Weeks Baseline and 12 week levels of physical activity will be measured using the International Physical Activity Questionnaire.
Feasibility as measured by attrition rate 12 Weeks The attrition rate will be measured by the number of patients who drop out of the study.
Aerobic Fitness 12 Weeks Aerobic fitness will be measured by comparing baseline and 12 week cardiac stress tests and the associated peak oxygen uptake values.
Cytokines (IL-17) 12 Weeks Baseline and 12 week levels (picogram per milileter) will be compared.
Feasibility as measured by program adherence 12 Weeks The program adherence will be calculated by dividing the total number of exercise sessions by the number of actual session attended.
C-reactive protein (CRP) 12 Weeks Baseline and 12 week levels will be compared.
Cytokines (IL-4) 12 Weeks Baseline and 12 week levels (picogram per milileter) will be compared.
Cytokines (IL-10) 12 Weeks Baseline and 12 week levels (picogram per milileter) will be compared.
Cardiac Function 12 Weeks Cardiac function will be measured by examining heart chamber size, ventricular function and blood flow between the cardiac chambers using a Multigated acquisition (MUGA) scan.
Life Quality 12 Weeks The Functional Assessment of Cancer Therapy - General questionnaire along with the appropriate tumor specific appendix, will be used to compare baseline and 12 week quality of life measures.
High-sensitivity Troponin (hs-TNT) 12 Weeks Baseline and 12 week levels will be compared.
N-terminal of the prohormone brain natriuretic peptide (NTproBNP) 12 Weeks Baseline and 12 week levels will be compared.
Cytokines (IL-1β) 12 Weeks Baseline and 12 week levels (picogram per milileter) will be compared.
Cytokines (IL-6) 12 Weeks Baseline and 12 week levels (picogram per milileter) will be compared.
Cytokines (TNFα) 12 Weeks Baseline and 12 week levels (picogram per milileter) will be compared.
Trial Locations
- Locations (1)
QEII Health Science Center, Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada