NCT07622394
Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors
Not Yet Recruiting · Not Applicable · Xinjiang Medical University · registry updated 2026-06-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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.
Exclusion
- 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.