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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 800
- Locations
- 1
Study Overview
Brief 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.
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:
- Structured cardio-oncology rehabilitation plus usual care; or
- Usual care alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Participants, care providers, and treating investigators cannot be masked because of the nature of the rehabilitation intervention. Outcome assessors, laboratory staff, endpoint adjudicators, and statisticians will remain blinded to treatment allocation.
Eligibility Criteria
- Ages
- 18 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Xiang Xie
Principal Investigator
Xinjiang Medical University