Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors

NCT07622394 | Not Yet Recruiting DMC

• 1 other identifier: CORE-CTRCD-RCT-2026
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Structured Cardio-Oncology Rehabilitation; Cardiac Rehabilitation; Cancer Survivors; Major Adverse Cardiovascular Events; Exercise Training; Cardiorespiratory Fitness; CTRCD

Outcome Measures

Primary Outcomes (1)

• Time to First Major Adverse Cardiovascular Event (MACE)

  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.

  From randomization to 12 months

Secondary Outcomes (12)

• Change in Peak Oxygen Uptake

  From baseline to 12 months

• Change in HADS Depression Score

  From baseline to 12 months

• Change in Left Ventricular Ejection Fraction

  From baseline to 12 months

• Change in Global Longitudinal Strain

  From baseline to 12 months

• Change in NT-proBNP

  From baseline to 12 months

Study Arms (2)

Structured Cardio-Oncology Rehabilitation

EXPERIMENTAL

Participants will receive a structured cardio-oncology rehabilitation program combined with usual care. The intervention includes individualized aerobic and resistance exercise training, nutritional management, psychosocial support, cardiovascular risk-factor optimization, and patient education for 12 weeks, followed by maintenance rehabilitation guidance through 12 months.

Behavioral: Structured Cardio-Oncology Rehabilitation

Usual Care

ACTIVE COMPARATOR

Participants will receive usual cardio-oncology care, including routine oncology and cardiovascular follow-up and general health advice, without structured cardio-oncology rehabilitation.

Behavioral: Usual Care

Interventions

Structured Cardio-Oncology Rehabilitation BEHAVIORAL

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.

Structured Cardio-Oncology Rehabilitation

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinjiang Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xiang Xie, PhD

CONTACT

+86 15099169036; xiangxie999@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio to receive either structured cardio-oncology rehabilitation plus usual care or usual care alone.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication of the primary study results and ending 5 years after publication.
• Access Criteria: Qualified researchers who provide a methodologically sound proposal may gain access to de-identified individual participant data and supporting documents. Requests will be reviewed by the study investigators and sponsoring institution. Data will be shared after approval of a data access agreement and will be provided through a secure data-sharing platform or institutional repository.

Locations

CN (1)