Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors

Sponsor
Xinjiang Medical University
Study ID
NCT07622394
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Months - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jun 3, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Structured Cardio-Oncology Rehabilitation
    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.
  • Active Comparator: Usual Care
    Participants will receive usual cardio-oncology care, including routine oncology and cardiovascular follow-up and general health advice, without structured cardio-oncology rehabilitation.

Primary Outcome Measure

Time to First Major Adverse Cardiovascular Event (MACE) [ Time Frame: From randomization to 12 months ]

Central Contacts

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