Pediatric, adolescent and young adult cancer survivors (PAYA-CS) are at higher risk of cardiovascular (CV) morbidity and mortality. This is a consequence of prior cancer-related therapies that have the potential of producing cardiac dysfunction, reducing cardiorespiratory fitness (reduced VO2peak) and psychosocial morbidities (i.e., anxiety and depression). A reduction of physical activity levels can evoke functional limitations resulting in a vicious cycle of reduced exercise tolerance and physical deterioration. To date, there is limited evidence on the use of non-pharmacological strategies such as Cardio-Oncology Rehabilitation (CORE) including structured exercise, behavioural support and risk factor management to improve the outcomes of this underserved population. The HIMALAYAS study is a randomized controlled trial designed to evaluate the impact of a CORE intervention (consisting of six-months home and onsite-based structured moderate to high-intensity aerobic exercise training and CVD risk factor management) on CV and psychosocial health, and the cardiovascular disease risk in PAYA-CS with mild heart dysfunction (stage B heart failure) compared to standard of care (i.e. providing guidance on the current exercise recommendations for cancer survivors). The primary objective of the HIMALAYAS study is to determine whether a six-month supervised CORE intervention, consisting of individualized moderate to high-intensity aerobic exercise training, CVD risk factor modification and enhanced online behavioral support, improves cardiorespiratory fitness (VO2peak; primary outcome), cardiac function, CVD risk factors and biomarkers, and patient-reported outcomes (PROs) at six- months follow-up compared to standard of care (CON) in PAYA-CS with stage B heart failure. The secondary objective is to assess the same outcomes at 12- and 24-months follow-up. We will recruit 336 patients across 5 sites in Canada and upto 134 patients at UHN in 3 years and conclude in 6 years.
Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;
Be 18-45 years of age at the time of enrolment;
Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors);
Be cancer-free at the time of enrollment;
Have an absolute or unresolved relative contraindication to exercise according to the American College of Sports Medicine guidelines;
Have an untreated physical or mental health concern that precludes safe and effective exercise participation;
Have established CVD (excluding mildly reduced LVEF as described above);
Be pregnant at time of recruitment;
University Health Network, Toronto
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Queen Elizabeth II Health Sciences Centre
Collaborator
Alberta Health services
Collaborator
Vancouver General Hospital
Collaborator
Université de Montréal
Collaborator
Dalhousie University
Collaborator
University of Alberta
Collaborator
University of British Columbia
Collaborator
University of Toronto
Collaborator