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Cardio-Oncology Rehabilitation (CORE) for Cardiotoxicity (HIMALAYAS Trial)

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received cancer treatment(s) with known cardiovascular risks (e.g. anthracyclines, radiotherapy, trastuzumab, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors) in the previous 5 years;

Be an AYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study initiation to end of 66-month study period (primary and secondary rcts)

Awards & highlights

HIMALAYAS Trial Summary

This trial aims to study the effectiveness of a Cardio-Oncology Rehabilitation (CORE) program on the cardiovascular and psychosocial health of pediatric, adolescent, and young adult cancer survivors (PAYA-CS

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include muscle soreness, fatigue from exercise programs in CORE intervention; however, these are generally well-tolerated and beneficial for long-term cardiovascular health.

HIMALAYAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I am 18 years old or older.

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I am currently cancer-free.

HIMALAYAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study initiation to end of 66-month study period (primary and secondary rcts)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study initiation to end of 66-month study period (primary and secondary rcts)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study initiation to end of 66-month study period (primary and secondary rcts) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Anaerobic threshold

Anxiety

Apolipoprotein B

+28 more

Other outcome measures

Behavioural Compliance

Energy expenditure during HIIT

Exercise Adherence

+13 more

HIMALAYAS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cardio-Oncology Rehabilitation (CORE)Experimental Treatment1 Intervention

Participants in the CORE group will have A personalized, supervised exercise program ((in-person at intuition and virtual/ homebased exercises) CV risk factor management, 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 Control1 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

484,844 Total Patients Enrolled

5 Trials studying Cardiotoxicity

659 Patients Enrolled for Cardiotoxicity

Centre hospitalier de l'Université de Montréal (CHUM)OTHER

366 Previous Clinical Trials

129,301 Total Patients Enrolled

Queen Elizabeth II Health Sciences CentreOTHER

23 Previous Clinical Trials

13,774 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"As per the information available on clinicaltrials.gov, this particular study is not currently seeking participants. It was initially listed on January 1st, 2024 and last updated on January 5th, 2024. However, there are currently an impressive number of 1255 other trials actively accepting participants at present."

Answered by AI

Are individuals aged 80 and above eligible to participate in this study's patient recruitment process?

"To be eligible for participation in this research, potential candidates must fall within the age bracket of 18 to 45 years old. It is worth noting that there are a total of 83 studies targeting individuals below 18 years old and an additional 1184 studies focused on participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial

2024. "The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05023785.

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