NCT05023785Recruiting
The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial
The Harmonized Interventions to Maintain Health Via Appropriate Risk Factor Modification and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 336 (estimated)
- First submitted
- 29 Apr 2021
- Start date
- 1 Jan 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Heart failure
- NCT number
- NCT05023785
What you commit to
- Study type: Interventional
- Planned participants: 336
- From 1 Jan 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Have established CVD (excluding mildly reduced LVEF as described above);
Other
- 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;
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.