Rehabilitation for Cancer Survivors

(HIMALAYAS Trial)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: Established CVD, Pregnancy, High-intensity exercise, others

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 6 7}

Research Team

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

I've had cancer treatments that could affect my heart in the last 5 years.

I was diagnosed with cancer at or before the age of 39.

I have been diagnosed with a specific heart condition affecting its function and structure.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

6 months

Weekly in-person and virtual/home-based sessions

Follow-up

Participants are monitored for cardiorespiratory fitness, cardiac function, CVD risk factors, and patient-reported outcomes

18 months

Regular follow-up assessments

Long-term Follow-up

Ongoing behavioral support and monitoring of physical activity and health outcomes

24 months

Treatment Details

Interventions

• Cardio-oncology Rehabilitation (CORE) (Behavioural Intervention)
• Exercise Guidelines for Cancer Survivors (ExGL) (Behavioural Intervention)
• PAI Group (PAI) (Behavioural Intervention)

Trial Overview The HIMALAYAS study tests a Cardio-Oncology Rehabilitation (CORE) program against standard care in young adult cancer survivors with mild heart issues. CORE includes exercise, behavioral support, and managing heart disease risk factors over six months to improve fitness and psychosocial health.

Participant Groups

Group I: Cardio-Oncology Rehabilitation (CORE) Experimental Treatment 1 Intervention

Participants in the CORE group will have 1. A personalized, supervised exercise program ((in-person at intuition and virtual/ homebased exercises) 2. CV risk factor management, 3. behavioural support for the first 6 months. The behavioural support will continue for CORE participants from months 7-24. Behavioural support includes professionally guided and peer-enhanced exercise behavioural support based on behaviour change stage theories. CORE participants will be provided a wrist-worn heart and physical activity monitor to use throughout the 24-month observation period.

Group II: Standard of Care (CON) Active Control 1 Intervention

Participants in the CON group will receive standard medical care and physical activity will be monitored by a wrist-worn activity tracker for 2 years.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Dr. Réjean Lapointe

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Medical Officer since 2023

MD from Université de Montréal

Dr. Fabrice Brunet

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Executive Officer since 2015

MD from Université de Montréal

Queen Elizabeth II Health Sciences Centre

Collaborator

Trials

26

Recruited

14,200+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Dr. Verna Yiu

Alberta Health services

Chief Medical Officer

MD

Andre Tremblay

Alberta Health services

Chief Executive Officer

Bachelor's degree in a relevant field

Vancouver General Hospital

Collaborator

Trials

42

Recruited

19,700+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Houda Bahig

Université de Montréal

Chief Medical Officer since 2021

MD from Université de Montréal

Daniel Jutras

Université de Montréal

Chief Executive Officer since 2020

LLB from Université de Montréal, LLM from Harvard University

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Dr. David Berd

Dalhousie University

Chief Medical Officer since 2020

MD

Dr. Kim Brooks

Dalhousie University

Chief Executive Officer since 2023

PhD in Tax Law

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Dr. Christopher Haqq

University of British Columbia

Chief Medical Officer since 2019

MD, University of British Columbia

Bekki Bracken Brown

University of British Columbia

Chief Executive Officer since 2023

Bachelor's degree from Duke University

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Allison Brown

University of Toronto

Chief Medical Officer

PhD in Chemical Engineering from the University of Toronto

Michael Sefton

University of Toronto

Chief Executive Officer since 2017

PhD in Chemical Engineering from the University of Toronto and MIT

Findings from Research

The rise in cancer survival rates has led to an increase in patients facing both cancer and cardiovascular diseases, highlighting the need for integrated care in cardio-oncology to manage shared risk factors and mitigate the cardiotoxic effects of cancer treatments.

The Cardio-Oncology REhabilitation (CORE) program is an exercise-based intervention designed to improve cardiovascular health in cancer patients, offering benefits such as enhanced cardiorespiratory fitness, better quality of life, and psychological support, while also addressing barriers to its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The core components of cardio-oncology rehabilitation. Venturini, E., Gilchrist, S., Corsi, E., et al.[2022]

As the number of cancer survivors increases, so does the risk of cardiovascular disease (CVD) among them, highlighting the need for integrated care in cancer treatment.

Cardio-oncology rehabilitation (CORE) is a new approach designed to reduce CVD risk and enhance fitness in cancer survivors through tailored exercise and cardiac rehabilitation, addressing the emerging issue of cancer treatment-related cardiovascular disease (CTRCD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. Sase, K., Kida, K., Furukawa, Y.[2021]

A 12-week home-based cardio-oncology rehabilitation (CORE) program using telerehabilitation was found to be safe and feasible for 11 hematological cancer survivors, with 80% adherence to the exercise sessions.

Participants showed a significant improvement in cardiorespiratory fitness, with an increase of 2.6 ml/kg/min and peak workload, indicating that this intervention can effectively enhance fitness levels in cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. Filakova, K., Janikova, A., Felsoci, M., et al.[2023]

Cardiac rehabilitation (CR) for cancer survivors shows low-to-moderate quality in reporting and moderate-to-high risk of bias, which affects the reliability of the findings and their application in clinical practice.

Despite the quality concerns, survivors who completed CR demonstrated improved cardiorespiratory fitness and reduced fatigue compared to those who did not participate in CR, suggesting potential benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. Fakhraei, R., Peck BKin, SS., Abdel-Qadir, H., et al.[2022]

Cancer patients, especially those with early-stage disease, face a higher risk of cardiovascular disease due to both cancer treatments and lifestyle factors, highlighting the need for effective risk mitigation strategies.

The American Heart Association advocates for a multimodal approach, specifically cardiac rehabilitation, to support cancer patients by providing structured exercise and addressing unique cardiac risks associated with cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. Gilchrist, SC., Barac, A., Ades, PA., et al.[2020]

Exercise therapy significantly improves cardiorespiratory fitness in cancer patients and helps reduce the cardiotoxic effects of cancer treatments, making it a crucial part of cardiac rehabilitation programs.

Starting exercise early after a cancer diagnosis and continuing throughout survivorship is generally safe and beneficial for heart health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. Tong, CKW., Lau, B., Davis, MK.[2021]

Cancer survivors often face impairments from their disease and treatment that can be improved through rehabilitation, highlighting the need for specialized programs.

Existing community-based cardiac rehabilitation (CR) programs can be adapted to create effective oncology rehabilitation services, requiring only minor adjustments, and preliminary evidence shows that these programs can enhance both psychological and physiological well-being in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based oncology rehabilitation: leveraging the cardiac rehabilitation model. Dittus, KL., Lakoski, SG., Savage, PD., et al.[2018]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The core components of cardio-oncology rehabilitation. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise-based oncology rehabilitation: leveraging the cardiac rehabilitation model. [2018]