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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Aug 19, 2021

Keywords

ClinConnect Summary

The HIMALAYAS Trial is a study designed to help young cancer survivors who are experiencing heart problems caused by their previous cancer treatments. This trial is looking at a specific program called Cardio-Oncology Rehabilitation (CORE), which includes structured exercise and support to improve heart health and overall well-being. Participants in the trial will either join the CORE program, which lasts for six months, or receive standard care that provides general advice on exercise. The goal is to see if the CORE program can better improve heart function, physical fitness, and emotional health compared to standard care.

To be eligible for this trial, participants need to be young adults aged 18-45 who were diagnosed with cancer before age 39 and are now cancer-free but have mild heart issues. They should not have serious health concerns that would make exercise unsafe. Those who join the study can expect to engage in a supervised exercise program tailored to their needs, along with support to manage their heart health. The study will track their progress over six months, and then again at 12 and 24 months, to assess the benefits of this program. This trial is currently recruiting participants across multiple centers in Canada.

Gender

ALL

Eligibility criteria

• 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.