Rehabilitation for Cancer Survivors
(HIMALAYAS Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on exercise and rehabilitation, it might not require changes to your medication regimen. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Rehabilitation for Cancer Survivors is an effective treatment?
The available research shows that Rehabilitation for Cancer Survivors, also known as Cardio-Oncology Rehabilitation (CORE), is effective in improving the health of cancer survivors. It helps improve cardiorespiratory fitness, which is how well the heart and lungs work together, and enhances the overall quality of life. CORE also provides psychological support and helps with weight management. This treatment is especially important because cancer therapies can increase the risk of heart problems. By using exercise and other supportive measures, CORE helps reduce this risk and supports better health outcomes for cancer survivors.12345
What safety data exists for cardio-oncology rehabilitation in cancer survivors?
Cardio-oncology rehabilitation (CORE) is generally considered safe for cancer survivors. It aims to reduce cardiovascular disease risk and improve cardiopulmonary fitness through exercise prescriptions and cardiac rehabilitation. Studies have shown that exercise therapy, a key component of CORE, is safe and beneficial for improving cardiorespiratory fitness and mitigating cardiotoxic effects of cancer treatments. A feasibility study on home-based CORE using telerehabilitation also evaluated its safety, indicating its potential as a safe intervention for hematological cancer survivors.12346
Is Cardio-oncology Rehabilitation (CORE) a promising treatment for cancer survivors?
Yes, Cardio-oncology Rehabilitation (CORE) is a promising treatment for cancer survivors. It helps improve heart and lung fitness, quality of life, and overall well-being. CORE combines exercise, risk factor control, psychological support, and nutrition counseling to help cancer survivors manage cardiovascular risks and counteract the negative effects of cancer therapies.12467
Eligibility Criteria
This trial is for young cancer survivors under 39 diagnosed at the time of their cancer, now aged 18 or older. They must have had treatments with cardiovascular risks within the last 5 years and be free of cancer at enrollment. Participants should have mild heart dysfunction but cannot join if they don't meet specific heart health criteria.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 6-month supervised CORE intervention, including moderate to high-intensity aerobic exercise training, CVD risk factor modification, and enhanced online behavioral support
Follow-up
Participants are monitored for cardiorespiratory fitness, cardiac function, CVD risk factors, and patient-reported outcomes
Long-term Follow-up
Ongoing behavioral support and monitoring of physical activity and health outcomes
Treatment Details
Interventions
- Cardio-oncology Rehabilitation (CORE)
- Exercise Guidelines for Cancer Survivors (ExGL)
- PAI Group (PAI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Queen Elizabeth II Health Sciences Centre
Collaborator
Alberta Health services
Collaborator
Vancouver General Hospital
Collaborator
Université de Montréal
Collaborator
Dalhousie University
Collaborator
University of Alberta
Collaborator
University of British Columbia
Collaborator
University of Toronto
Collaborator