The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial
Recruiting · NCT05023785 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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;
- Stage B Heart Failure (SBHF)
- In patients with availability of pre-treatment imaging:
- ≥10% decrease in LVEF at post-treatment compared to pre-treatment
- ≥15% decrease in GLS at post-treatment compared to pre-treatment
- No pre-treatment imaging:
- LVEF ≤53% in women/51% in men
- GLS \>-18%
- Left ventricular hypertrophy (LV mass/body surface area: \>95 g/m2 for women or \>115 g/m2 for men)
- Concentric remodelling (\>0.42 relative wall thickness)
- Diastolic dysfunction (≥ grade 1)
- BNP ≥35pg/ml or NT-proBNP ≥125pg/ml
Exclusion criteria
- 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;
- Be currently engaging in frequent high-intensity exercise (\>1 high-intensity exercise session per week);
- Have substantial barriers to participating, including (1) living too far from study centre or (2) being unable or willing to comply with the study protocol.
Where it is running
1 location listed.
- University Health Network - Toronto, Ontario, Canada