RecruitingNot ApplicableNCT05023785

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

Sponsor

University Health Network, Toronto

Enrollment

336 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cancer Cardiotoxicity

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria15

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 Criteria6

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.

Interventions

BEHAVIORALCardio-oncology Rehabilitation (CORE)

Exercise therapy, CVD risk factor management for the first 6 months (as per current standards in CR models) and behavioural support for the entire 2-year intervention period