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The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial

RecruitingNAAges 18 Years - 45 YearsAllUniversity Health Network, Toronto
NCT05023785 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis; 2. Be 18-45 years of age at the time of enrolment; 3. Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors); 4. Be cancer-free at the time of enrollment; 5. 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: 1. Have an absolute or unresolved relative contraindication to exercise according to the American College of Sports Medicine guidelines; 2. Have an untreated physical or mental health concern that precludes safe and effective exercise participation; 3. Have established CVD (excluding mildly reduced LVEF as described above); 4. Be pregnant at time of recruitment; 5. Be currently engaging in frequent high-intensity exercise (\>1 high-intensity exercise session per week); 6. 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.
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What it tests

  • Cardio-oncology Rehabilitation (CORE)
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Where

1 site
University Health Network
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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