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NCT07622394

Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors

Sponsor: Xinjiang Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Months - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-09-01

Completion Date

2029-09-30

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Cancer Therapy-Related Cardiac Dysfunction Cardio-oncology Cancer Survivorship Cardiovascular Risk Heart Failure

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Usual Care

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

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.

Locations (1)

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China