Exercise Program for Young Cancer Survivors

(HIMALAYAS-P Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Contraindication to exercise, untreated health concerns, established CVD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an exercise program can help young cancer survivors with mild heart issues improve their heart and mental health. Participants will either join a detailed exercise and support program called Cardio-oncology Rehabilitation (CORE) or receive only behavioral support to compare results. The trial focuses on individuals who underwent cancer treatments known to affect the heart and are currently cancer-free. Young cancer survivors with mild heart dysfunction may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance heart and mental health care for young cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise and cardiovascular health for young cancer survivors.

What prior data suggests that this exercise program is safe for young cancer survivors?

Research has shown that exercise-based Cardio-oncology Rehabilitation (CORE) programs can be safe and beneficial for cancer survivors with potential heart issues. One study found that participants in a CORE program improved their heart and lung fitness, indicating better function during exercise. This suggests the program is generally well-tolerated.

Another study examined CORE programs and found them effective in managing heart-related risks, such as high blood pressure and cholesterol. Although these studies did not report major negative effects, individual experiences may vary. It is crucial to consult healthcare professionals to understand the potential risks and benefits for personal health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cardio-oncology Rehabilitation (CORE) program for young cancer survivors because it uniquely combines exercise therapy, cardiovascular risk management, and behavioral support into a comprehensive rehabilitation approach. Unlike standard care, which often focuses solely on general physical activity recommendations, CORE offers tailored high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) based on individual fitness assessments. This personalized exercise regimen, coupled with peer support and ongoing education, aims to not only improve physical fitness but also manage cardiovascular risks effectively, providing a holistic recovery path for cancer survivors.

What evidence suggests that this trial's treatments could be effective for young cancer survivors with mild heart dysfunction?

Research has shown that cardio-oncology rehabilitation (CORE), one of the treatment arms in this trial, can greatly improve heart health in cancer survivors. Studies have found that CORE programs lead to better heart health compared to regular exercise routines. For example, cancer survivors who participated in CORE experienced improved heart and lung fitness. These programs also help manage heart disease risk factors, such as maintaining healthy blood sugar levels. The American Heart Association supports this type of rehab because it effectively enhances heart health in cancer survivors. Meanwhile, another arm of this trial, the Support group, will receive behavioral support to help meet physical activity guidelines for cancer survivors. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young cancer survivors under 39 years old at diagnosis, now aged 18+, who've had treatments with heart risks in the past year and are currently cancer-free. They must have mild heart dysfunction but can't join if they don't meet these specific health criteria.

Inclusion Criteria

I have received cancer treatments that could affect my heart.

I am currently free of cancer.

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

Exclusion Criteria

Be currently engaging in high-intensity exercise (>1 high-intensity exercise session per week)

An absolute or relative contraindication to exercise according to the American College of Sports Medicine (ACSM) guidelines

I do not have untreated health issues that stop me from safely exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive exercise therapy, CVD risk factor management, and behavioural support

6 months

Weekly sessions (combination of supervised and home-based)

Follow-up

Participants are monitored for changes in VO2peak, cardiac function, and other health outcomes

24 months

Regular follow-ups at 6, 12, and 24 months

Passive Behavioural Support

Participants receive wrist-worn heart rate monitors and are challenged to meet physical activity guidelines

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Cardio-oncology Rehabilitation (CORE)
• Passive Behavioural Support
• Support

Trial Overview

The HIMALAYAS study tests an exercise-based cardio-oncology rehab (CORE) to see its effects on heart and psychosocial health versus just getting behavioral support. It's a pilot study to check if a larger trial would be workable, focusing on safety and how well participants stick with it.

How Is the Trial Designed?

Group I: Support Experimental Treatment 1 Intervention

The Support group will receive the behavioural support only. The timing and nature of all education, information provided to Support participants will be identical to what is provided to CORE participants. All Support participants will receive the same wrist-worn HR monitor and PA tracker as the CORE participants and will be given the challenge of meeting and maintaining the updated PA guidelines for cancer survivors (i.e., 90 to 150 minutes of moderate to vigorous intensity PA per week).

Group II: Cario-Oncology Rehabilitation (CORE) Experimental Treatment 1 Intervention

CORE consists of exercise therapy, CVD risk factor management, and behavioural support for 3 months. Exercise therapy: Staff will prescribe and deliver a standardized, yet individually tailored (based on CPET results), aerobic exercise programs consisting of two days of supervised, facility- and home-based high-intensity interval training (HIIT) and one day of supervised home-based moderate-intensity continuous training (MICT) per week. Exercise HRs and durations will be monitored using an accurate commercially available wrist-worn HR monitor and PA tracker. CVD risk factor management: CVD risk factors will be assessed and treated according to Canadian guidelines. Behavioural support: All participants will receive a planned sequence of educational and instructional material via email and ongoing PAYA-CS tailored education and peer support during the follow-up period using a peer support online system.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

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]

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]

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]

Women with breast cancer and treatment-related heart failure showed significant improvements in peak aerobic power (VO2peak) after cardiac rehabilitation, similar to age-matched women with coronary artery disease, indicating the efficacy of rehabilitation for both groups.

Completion rates for the cardiac rehabilitation program were comparable between women with breast cancer and those with coronary artery disease, suggesting that cardiac rehabilitation is equally accessible and beneficial for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation for women with breast cancer and treatment-related heart failure compared with coronary artery disease: A retrospective study. Bonsignore, A., Marzolini, S., Oh, P.[2018]

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]

Citations

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Cardio-oncology and Cancer Rehabilitation

The American Heart Association endorses a multimodal cardiac rehabilitation (CR)-based approach to improve cardiovascular outcomes in cancer survivors.

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The aim of this study was to evaluate the quality of reporting and evidence from CR-based intervention studies in oncology and to explore associations