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Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors
Condition(s) studied
Cancer Therapy-Related Cardiac DysfunctionCardio-oncologyCancer SurvivorshipCardiovascular RiskHeart Failure
Investigational drug(s) / intervention(s)
Structured Cardio-Oncology RehabilitationUsual Care
Structured Cardio-Oncology Rehabilitation: 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 Care: Participants receive routine oncology and cardiovascular follow-up and general health advice without structured cardio-oncology rehabilitation or supervised exercise training.
Study 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 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.
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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Time to First Major Adverse Cardiovascular Event (MACE) — From randomization to 12 months
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Xinjiang Medical University |
Ürümqi |
Xinjiang |
|
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