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Structured Cardio-Oncology Rehabilitation for Cardiovascular Outcomes in Cancer Survivors (CORE-CTRCD)

2. Juni 2026 aktualisiert von: Xiang Xie, Xinjiang Medical University

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

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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:

  1. Structured cardio-oncology rehabilitation plus usual care; or
  2. Usual care alone.

The intervention consists of a 12-week intensive rehabilitation phase followed by long-term maintenance guidance. Core components include:

  • Individualized aerobic and resistance exercise training;
  • Nutritional assessment and management;
  • Psychosocial and behavioral support;
  • Intensive cardiovascular risk-factor management;
  • Patient education and self-management support. The primary endpoint is time to first major adverse cardiovascular event (MACE) within 12 months, including cardiovascular death, myocardial infarction, ischemic stroke, hospitalization for worsening heart failure, or urgent ICD/CRT implantation due to malignant arrhythmia or heart failure.

Secondary endpoints include:

  • Changes in peak oxygen uptake (VO2peak);
  • Changes in left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS);
  • Biomarkers including hs-cTnI and NT-proBNP;
  • Quality-of-life assessments;
  • Physical function measures;
  • Psychological outcomes;
  • Safety outcomes and health economic outcomes. Outcome assessment personnel, laboratory staff, endpoint adjudicators, and statisticians will remain blinded to treatment allocation. The study includes centralized imaging review, standardized intervention protocols, electronic data capture, and oversight by an independent Data and Safety Monitoring Board (DSMB).

The findings of this trial are expected to provide high-quality evidence supporting the implementation of standardized cardio-oncology rehabilitation strategies in cancer survivors with cardiovascular toxicity or elevated cardiovascular risk.

Studientyp

Interventionell

Einschreibung (Geschätzt)

800

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Aktiver Komparator: 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.
Verhalten: Usual Care
Participants receive routine oncology and cardiovascular follow-up and general health advice without structured cardio-oncology rehabilitation or supervised exercise training.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to First Major Adverse Cardiovascular Event (MACE)
Zeitfenster: From randomization to 12 months
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Peak Oxygen Uptake
Zeitfenster: From baseline to 12 months
Change in peak oxygen uptake (VO2peak) measured by cardiopulmonary exercise testing.
From baseline to 12 months
Change in HADS Depression Score
Zeitfenster: From baseline to 12 months
The Hospital Anxiety and Depression Scale (HADS) Depression subscale ranges from 0 to 21, with higher scores indicating greater depressive symptoms.
From baseline to 12 months
Change in Left Ventricular Ejection Fraction
Zeitfenster: From baseline to 12 months
Change in left ventricular ejection fraction (LVEF) measured by three-dimensional echocardiography.
From baseline to 12 months
Change in Global Longitudinal Strain
Zeitfenster: From baseline to 12 months
Change in global longitudinal strain (GLS) measured by echocardiography.
From baseline to 12 months
Change in NT-proBNP
Zeitfenster: From baseline to 12 months
Change in N-terminal pro-B-type natriuretic peptide level.
From baseline to 12 months
Exercise-Related Adverse Events
Zeitfenster: From randomization to 12 months
Incidence of adverse events related to the rehabilitation intervention or exercise training.
From randomization to 12 months
Change in High-Sensitivity Cardiac Troponin I
Zeitfenster: From baseline to 12 months
Change in high-sensitivity cardiac troponin I level.
From baseline to 12 months
Change in 6-Minute Walk Distance
Zeitfenster: From baseline to 12 months
Change in 6-minute walk distance measured by the 6-minute walk test.
From baseline to 12 months
Change in SF-36 Score
Zeitfenster: From baseline to 12 months
Change in the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
From baseline to 12 months
Change in EORTC QLQ-C30 Global Health Status Score
Zeitfenster: From baseline to 12 months
Change in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status score. Scores range from 0 to 100, with higher scores indicating better quality of life.
From baseline to 12 months
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety subscale score.
Zeitfenster: From baseline to 12 months
The Hospital Anxiety and Depression Scale (HADS) Anxiety subscale ranges from 0 to 21, with higher scores indicating greater anxiety symptoms.
From baseline to 12 months
Anti-Cancer Treatment Interruption
Zeitfenster: From randomization to 12 months
Incidence of interruption of anti-cancer treatment during the study period.
From randomization to 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Xinjiang Medical University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

30. September 2029

Studienabschluss (Geschätzt)

30. September 2029

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CORE-CTRCD-RCT-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the results reported in publications arising from this study will be shared, including demographic data, baseline characteristics, outcome measures, adverse events, and follow-up data.

IPD-Sharing-Zeitrahmen

Beginning 12 months after publication of the primary study results and ending 5 years after publication.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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