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Cancer Therapy-Related Cardiac DysfunctionCORE-CTRCDNCT07622394

Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors

A study testing Structured Cardio-Oncology Rehabilitation in people with Cancer Therapy-Related Cardiac Dysfunction and Cardio-oncology, run by Xinjiang Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Cancer therapy-related cardiac dysfunction (CTRCD) has become a major cause of morbidity and mortality among cancer survivors. Although cardiac rehabilitation is recommended for cardiovascular disease prevention and management, high-quality randomized controlled evidence regarding its efficacy in cardio-oncology… Read more about this study

Who is it for?
Ages 18 months and older
What is being tested?
Structured Cardio-Oncology Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
1 siteChina
Study dates
1 Sep 2026to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 18 years or older, regardless of sex.
  • Histologically or cytologically confirmed solid tumor or hematologic malignancy.
  • Completed curative anti-cancer therapy, or receiving stable adjuvant, maintenance, or palliative anti-cancer therapy.
  • Meets at least one criterion for cancer therapy-related cardiac dysfunction (CTRCD) or high cardiovascular risk, including reduced LVEF after anti-cancer therapy, high-dose anthracycline exposure, chest radiotherapy with cardiovascular risk factors, heart failure after anti-cancer therapy, or elevated cardiac injury/heart failure biomarkers.
  • Estimated life expectancy of at least 24 months as assessed by the treating oncologist.
  • Able to complete baseline cardiopulmonary exercise testing and has no absolute contraindication to exercise training.
  • Able and willing to provide written informed consent and comply with study intervention and follow-up.

Who cannot join

  • Active progressive malignancy requiring urgent anti-cancer therapy, or estimated life expectancy less than 24 months.
  • Severe structural heart disease, including severe valvular disease, congenital heart disease, end-stage heart failure, or waiting for heart transplantation or left ventricular assist device implantation.
  • Absolute contraindications to exercise training, including uncontrolled malignant arrhythmia, acute myocarditis or pericarditis, acute coronary syndrome within 2 weeks, severe anemia, severe thrombocytopenia or neutropenia, uncontrolled hypertension, active infection, or severe musculoskeletal disease preventing exercise training.
  • Participation in a structured cardiac rehabilitation program within the previous 12 months, or regular moderate-to-vigorous aerobic or resistance training for at least 3 months before enrollment.
  • Implanted ICD or CRT, except pacemakers with exercise mode.
  • Severe psychiatric disease or cognitive impairment preventing participation.
  • Concurrent participation in another interventional clinical trial, or planned participation in another interventional clinical trial during the study period.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Xiang Xie, Ph.D., +86 15099169036, xiangxie999@sina.com

Other trials in China

About this study

Official title: A Multicenter, Prospective, Parallel-Group, Superiority Randomized Controlled Trial of Structured Cardio-Oncology Rehabilitation for Improving Cardiovascular Outcomes in Patients With Cancer Therapy-Related Cardiac Dysfunction or High Cardiovascular Risk

Cancer therapy-related cardiac dysfunction (CTRCD) has become a major cause of morbidity and mortality among cancer survivors. Although cardiac rehabilitation is recommended for cardiovascular disease prevention and management, high-quality randomized controlled evidence regarding its efficacy in cardio-oncology populations remains limited.

This multicenter, prospective, parallel-group, superiority randomized controlled trial aims to evaluate whether a structured cardio-oncology rehabilitation (CORE) program combined with usual care can improve cardiovascular outcomes in patients with CTRCD or cancer survivors at high cardiovascular risk, compared with usual care alone.

Read more

A total of 800 participants will be randomized in a 1:1 ratio to receive either structured cardio-oncology rehabilitation plus usual care or usual care alone. The intervention includes individualized exercise training, nutritional management, psychosocial support, cardiovascular risk-factor optimization, and patient education. Participants will be followed for 12 months.

The primary endpoint is time to first major adverse cardiovascular event (MACE) within 12 months. Secondary endpoints include changes in cardiorespiratory fitness, cardiac function, biomarkers, quality of life, physical function, psychological status, safety outcomes, and health economic outcomes.

Read the detailed description

With advances in anti-cancer therapies, the number of cancer survivors has increased substantially worldwide. However, cancer therapy-related cardiac dysfunction (CTRCD) has emerged as a major long-term complication associated with increased cardiovascular morbidity, mortality, reduced quality of life, and impaired survival. Current management strategies primarily focus on pharmacologic prevention and treatment, while evidence-based non-pharmacologic interventions capable of improving hard cardiovascular outcomes remain insufficient.

Cardiac rehabilitation is a Class I recommended intervention for patients with cardiovascular diseases and has demonstrated benefits in improving cardiorespiratory fitness, reducing cardiovascular events, and enhancing quality of life. Emerging studies suggest that cardio-oncology rehabilitation may improve exercise capacity and cardiac function in cancer survivors; however, most existing studies are limited by small sample size, single-center design, and lack of hard clinical endpoints.

This study is a multicenter, prospective, parallel-group, superiority randomized controlled trial designed to evaluate the efficacy and safety of a structured cardio-oncology rehabilitation (CORE) program in patients with CTRCD or cancer survivors at high cardiovascular risk.

A total of 800 participants will be enrolled and randomized in a 1:1 ratio to either:

  1. Structured cardio-oncology rehabilitation plus usual care; or
  2. Usual care alone.

The intervention consists of a 12-week intensive rehabilitation phase followed by long-term maintenance guidance. Core components include:

  • Individualized aerobic and resistance exercise training;
  • Nutritional assessment and management;
  • Psychosocial and behavioral support;
  • Intensive cardiovascular risk-factor management;
  • Patient education and self-management support. The primary endpoint is time to first major adverse cardiovascular event (MACE) within 12 months, including cardiovascular death, myocardial infarction, ischemic stroke, hospitalization for worsening heart failure, or urgent ICD/CRT implantation due to malignant arrhythmia or heart failure.

Secondary endpoints include:

  • Changes in peak oxygen uptake (VO2peak);
  • Changes in left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS);
  • Biomarkers including hs-cTnI and NT-proBNP;
  • Quality-of-life assessments;
  • Physical function measures;
  • Psychological outcomes;
  • Safety outcomes and health economic outcomes. Outcome assessment personnel, laboratory staff, endpoint adjudicators, and statisticians will remain blinded to treatment allocation. The study includes centralized imaging review, standardized intervention protocols, electronic data capture, and oversight by an independent Data and Safety Monitoring Board (DSMB).

The findings of this trial are expected to provide high-quality evidence supporting the implementation of standardized cardio-oncology rehabilitation strategies in cancer survivors with cardiovascular toxicity or elevated cardiovascular risk.

Being tested
Structured Cardio-Oncology Rehabilitation, Usual Care
Keywords
Structured Cardio-Oncology Rehabilitation, Cardiac Rehabilitation, Cancer Survivors, Major Adverse Cardiovascular Events, Exercise Training, Cardiorespiratory Fitness, CTRCD
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Cardio-Oncology RehabilitationBehavioural

    A structured cardio-oncology rehabilitation program including individualized aerobic and resistance exercise training, nutritional management, psychosocial support, cardiovascular risk-factor optimization, and patient education. The intervention consists of a 12-week intensive rehabilitation phase followed by maintenance rehabilitation guidance through 12 months.

  • Usual CareBehavioural

    Participants receive routine oncology and cardiovascular follow-up and general health advice without structured cardio-oncology rehabilitation or supervised exercise training.

Study groups in NCT07622394
Study groupRoleWhat they receive
Structured Cardio-Oncology RehabilitationExperimentalParticipants will receive a structured cardio-oncology rehabilitation program combined with usual care. The intervention includes individualized aerobic and resistance exercise training, nutritional management, psychosocial support, cardiovascular risk-factor optimization, and patient education for 12 weeks, followed by maintenance rehabilitation guidance through 12 months.
Receives: Behavioral: Structured Cardio-Oncology Rehabilitation
Usual CareActive comparatorParticipants will receive usual cardio-oncology care, including routine oncology and cardiovascular follow-up and general health advice, without structured cardio-oncology rehabilitation.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Major Adverse Cardiovascular Event (MACE)

    Time from randomization to the first occurrence of a major adverse cardiovascular event (MACE), including cardiovascular death, myocardial infarction, ischemic stroke, hospitalization for worsening heart failure, or urgent ICD/CRT implantation due to malignant arrhythmia or heart failure.

    Measured: From randomization to 12 months

Secondary outcomes (12)
  1. Change in Peak Oxygen Uptake

    Change in peak oxygen uptake (VO2peak) measured by cardiopulmonary exercise testing.

    Measured: From baseline to 12 months

  2. Change in HADS Depression Score

    The Hospital Anxiety and Depression Scale (HADS) Depression subscale ranges from 0 to 21, with higher scores indicating greater depressive symptoms.

    Measured: From baseline to 12 months

  3. Change in Left Ventricular Ejection Fraction

    Change in left ventricular ejection fraction (LVEF) measured by three-dimensional echocardiography.

    Measured: From baseline to 12 months

  4. Change in Global Longitudinal Strain

    Change in global longitudinal strain (GLS) measured by echocardiography.

    Measured: From baseline to 12 months

  5. Change in NT-proBNP

    Change in N-terminal pro-B-type natriuretic peptide level.

    Measured: From baseline to 12 months

  6. Exercise-Related Adverse Events

    Incidence of adverse events related to the rehabilitation intervention or exercise training.

    Measured: From randomization to 12 months

  7. Change in High-Sensitivity Cardiac Troponin I

    Change in high-sensitivity cardiac troponin I level.

    Measured: From baseline to 12 months

  8. Change in 6-Minute Walk Distance

    Change in 6-minute walk distance measured by the 6-minute walk test.

    Measured: From baseline to 12 months

  9. Change in SF-36 Score

    Change in the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.

    Measured: From baseline to 12 months

  10. Change in EORTC QLQ-C30 Global Health Status Score

    Change in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status score. Scores range from 0 to 100, with higher scores indicating better quality of life.

    Measured: From baseline to 12 months

  11. Change in Hospital Anxiety and Depression Scale (HADS) Anxiety subscale score.

    The Hospital Anxiety and Depression Scale (HADS) Anxiety subscale ranges from 0 to 21, with higher scores indicating greater anxiety symptoms.

    Measured: From baseline to 12 months

  12. Anti-Cancer Treatment Interruption

    Incidence of interruption of anti-cancer treatment during the study period.

    Measured: From randomization to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:1 ratio to receive either structured cardio-oncology rehabilitation plus usual care or usual care alone.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07622394
Sponsor's protocol ID
CORE-CTRCD-RCT-2026
Acronym
CORE-CTRCD
Status last verified
Jun 2026
First submitted
15 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in publications arising from this study will be shared, including demographic data, baseline characteristics, outcome measures, adverse events, and follow-up data.

Questions about this trial

What is this clinical trial studying?

A study testing Structured Cardio-Oncology Rehabilitation in people with Cancer Therapy-Related Cardiac Dysfunction and Cardio-oncology, run by Xinjiang Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiang Xie, PhD (+86 15099169036, xiangxie999@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Major Adverse Cardiovascular Event (MACE) (time frame: From randomization to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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