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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Cardio-oncology Rehabilitation (CORE) for young cancer survivors?

Research shows that exercise programs similar to Cardio-oncology Rehabilitation can improve physical activity, fitness, and quality of life in cancer survivors. Exercise is known to reduce fatigue, anxiety, and depression, and can help counteract the negative effects of cancer treatments. ^{1 2 3 4 5}

Is the Exercise Program for Young Cancer Survivors safe?

The Cardio-Oncology Rehabilitation (CORE) program, which includes exercise, has been studied for its safety and feasibility in cancer survivors, showing it can be safely implemented, even at home, to improve cardiovascular health and fitness. ^{1 6 7 8 9}

How is the CORE treatment different from other treatments for young cancer survivors?

The CORE treatment is unique because it combines exercise programs with cardiac rehabilitation to specifically address the cardiovascular risks associated with cancer treatments. It also includes psychological support and nutrition counseling, making it a comprehensive approach to improve overall well-being and counteract the negative effects of cancer therapies. ^{6 7 8 9 10}

What is the purpose of this trial?

Cardiovascular disease (CVD) is a major contributor to morbidity and mortality in pediatric, adolescent and young adult (AYA) cancer survivors (hereafter referred to as PAYA-CS). Exercise is a cornerstone of CVD prevention and treatment; yet, exercise has not been adopted as a standard of care in PAYA-CS at high CVD risk. The HIMALAYAS trial is designed to evaluate the feasibility and preliminary impact of an exercise-based CR on cardiovascular (CV) and psychosocial health, as well as CVD risk, in PAYA-CS with mild heart dysfunction (stage B heart failure (SBHF)). The primary objective of the HIMALAYAS pilot study is to assess the feasibility of a two-phase randomized controlled trial designed to evaluate impact of a 'CR-like' cardio-oncology rehabilitation (CORE) intervention on CV, psychosocial, and behavioural outcomes at 6 and 24 months, compared to behavioural support only (Support) in PAYA-CS. Screened PAYA-CS without SBHF and those with SBHF who do not participate in the RCT will be enrolled in a passive behavioural support (Support) group. The primary outcome is study feasibility, defined according to three primary criteria (i.e., participant recruitment, safety, and adherence). Secondary outcomes include additional feasibility metrics (e.g., intervention safety and tolerability) and exploratory efficacy outcomes including peak cardiorespiratory fitness (VO2peak), cardiac function (e.g., global longitudinal strain (GLS)), CVD risk factor control (e.g. insulin resistance), and patient-reported outcomes (e.g. anxiety). Our central hypothesis is that the conduct of a larger RCT comparing the impact of CORE versus non-intervention control will be feasible indicated by the achievement of our primary feasibility criteria. Our exploratory hypothesis is that we will generate preliminary evidence that CORE can improve VO2peak, cardiac function, CVD risk factor, and patient-reported outcomes over 6- and 24-month timepoints, relative to control.

Eligibility Criteria

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)

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of multimodal exercise-based rehabilitation on physical activity, cardiorespiratory fitness, and patient-reported outcomes in cancer survivors: a randomized, controlled trial. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Feasibility of an exercise intervention for fatigued breast cancer patients at a community-based cardiac rehabilitation program. [2020]

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

Research and commentary: Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. [2006]

4. Sweden 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. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Oncology and Cardiac Rehabilitation: An Underrated Relationship. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Exercise for the Prevention of Anthracycline-Induced Functional Disability and Cardiac Dysfunction: The BREXIT Study. [2023]

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

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