Cardiac rehabilitation for young cancer survivors
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
This study tests a special exercise program for young cancer survivors to see if it can help improve their heart health and overall fitness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05023785 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a Cardio-Oncology Rehabilitation (CORE) program for pediatric, adolescent, and young adult cancer survivors who are at increased risk of cardiovascular issues due to their cancer treatments. Participants will engage in a six-month structured exercise program that includes both home and onsite training, aimed at improving their cardiovascular health and overall fitness. The study will assess changes in physical fitness, cardiac function, and psychosocial well-being among participants. By focusing on non-pharmacological interventions, this trial seeks to address the unique health challenges faced by this underserved population.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors aged 18-45 who were diagnosed with cancer before age 40 and have experienced treatment-related cardiovascular risks.
Not a fit: Patients who are currently undergoing cancer treatment or those with advanced heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cardiovascular health and quality of life for young cancer survivors.
How similar studies have performed: Previous studies have shown promise in using exercise and rehabilitation programs for improving cardiovascular outcomes in cancer survivors, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Paaladinesh Thavendiranathan, MD
- Email: dinesh.thavendiranathan@uhn.ca
- Phone: 416-340-5326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.