Not Yet RecruitingNot Applicable

Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors

China800 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 neutropeni…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to First Major Adverse Cardiovascular Event (MACE)

Timeframe: From randomization to 12 months

Trial details

NCT IDNCT07622394

SponsorXinjiang Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-30

Contact for this trial

Xiang Xie, PhD

+86 15099169036 xiangxie999@sina.com

View on ClinicalTrials.gov More Cancer Therapy-Related Cardiac Dysfunction trials