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

2026年6月2日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

800

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Xinjiang
      • Ürümqi、Xinjiang、中国、830054
        • The First Affiliated Hospital of Xinjiang Medical University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
アクティブコンパレータ：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.
行動：Usual Care
Participants receive routine oncology and cardiovascular follow-up and general health advice without structured cardio-oncology rehabilitation or supervised exercise training.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to First Major Adverse Cardiovascular Event (MACE)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Peak Oxygen Uptake
時間枠：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
時間枠：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
時間枠：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
時間枠：From baseline to 12 months
Change in global longitudinal strain (GLS) measured by echocardiography.
From baseline to 12 months
Change in NT-proBNP
時間枠：From baseline to 12 months
Change in N-terminal pro-B-type natriuretic peptide level.
From baseline to 12 months
Exercise-Related Adverse Events
時間枠：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
時間枠：From baseline to 12 months
Change in high-sensitivity cardiac troponin I level.
From baseline to 12 months
Change in 6-Minute Walk Distance
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：From randomization to 12 months
Incidence of interruption of anti-cancer treatment during the study period.
From randomization to 12 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Xinjiang Medical University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2029年9月30日

研究の完了 (推定)

2029年9月30日

試験登録日

最初に提出

2026年5月15日

QC基準を満たした最初の提出物

2026年6月2日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CORE-CTRCD-RCT-2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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いいえ

米国FDA規制機器製品の研究

いいえ

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