An interventional study of Moderate Intensity Exercise in Neoplasms, Heart; Disease, Functional and Inflammation, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-06.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment
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.
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.
264 studies on the registry are indexed under Cardiotoxicity; 71 are open to participants now.
This study's enrollment of 12 is below the median of 93 across 137 interventional studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
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Inclusion Criteria - Only those patients who meet the following inclusion will be asked to participate in the study:
Exclusion Criteria:
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.
Other: Moderate Intensity Exercise
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.
Feasibility as measured by rate of recruitment
The rate of recruitment will be measured by comparing the number of patients screened to the number of patients enrolled (patients per month).
Time frame: 12 Weeks
Number of adverse events
The number of adverse events associated with exercise program will be used to examine safety.
Time frame: 12 Weeks
Feasibility as measured by program adherence
The program adherence will be calculated by dividing the total number of exercise sessions by the number of actual session attended.
Time frame: 12 Weeks
Feasibility as measured by attrition rate
The attrition rate will be measured by the number of patients who drop out of the study.
Time frame: 12 Weeks
Cardiac Function
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.
Time frame: 12 Weeks
Cardiac Disease Risk
Cardiac disease risk will be measured using the Framingham Risk Score.
Time frame: 12 Weeks
Aerobic Fitness
Aerobic fitness will be measured by comparing baseline and 12 week cardiac stress tests and the associated peak oxygen uptake values.
Time frame: 12 Weeks
Fatigue
The Functional Assessment of Cancer Therapy - Fatigue questionnaire will be used to compare baseline and 12 week self-reported levels of fatigue.
Time frame: 12 Weeks
Physical Activity Behaviours
Baseline and 12 week levels of physical activity will be measured using the International Physical Activity Questionnaire.
Time frame: 12 Weeks
Life Quality
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.
Time frame: 12 Weeks
Lipid Profile
Baseline and 12 week levels will be compared.
Time frame: 12 Weeks
Fasting Glucose
Baseline and 12 week levels will be compared.
Time frame: 12 Weeks
High-sensitivity Troponin (hs-TNT)
Baseline and 12 week levels will be compared.
Time frame: 12 Weeks
N-terminal of the prohormone brain natriuretic peptide (NTproBNP)
Baseline and 12 week levels will be compared.
Time frame: 12 Weeks
C-reactive protein (CRP)
Baseline and 12 week levels will be compared.
Time frame: 12 Weeks
Cytokines (IL-1α)
Baseline and 12 week levels (picogram per milileter) will be compared.
Time frame: 12 Weeks
Cytokines (IL-1β)
Baseline and 12 week levels (picogram per milileter) will be compared.
Time frame: 12 Weeks
Cytokines (IL-4)
Baseline and 12 week levels (picogram per milileter) will be compared.
Time frame: 12 Weeks
Cytokines (IL-6)
Baseline and 12 week levels (picogram per milileter) will be compared.
Time frame: 12 Weeks
Cytokines (IL-10)
Baseline and 12 week levels (picogram per milileter) will be compared.
Time frame: 12 Weeks
Cytokines (IL-17)
Baseline and 12 week levels (picogram per milileter) will be compared.
Time frame: 12 Weeks
Cytokines (TNFα)
Baseline and 12 week levels (picogram per milileter) will be compared.
Time frame: 12 Weeks
Plan to share: No
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Nova Scotia Health Authority