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Cardio-Oncology Rehabilitation in Breast Cancer Patients Undergoing Chemotherapy

2026年9月14日 更新者:Hospital de Clinicas de Porto Alegre

Effect of Chemotherapy Treatment on the Cardiovascular System: Clinical Profile of Patients Diagnosed With Breast Cancer and an Integrated Cardio-Oncology Rehabilitation Approach. A Randomized Clinical Trial

Breast cancer is the most prevalent malignancy among women in Brazil, and Porto Alegre (Rio Grande do Sul) has one of the highest incidence rates in women under 50, with 165.5 cases per 100,000 women aged 40-49. Advances in cancer biology, treatment, and supportive care have improved outcomes, leading to increased survivorship. Regular physical exercise has been shown to be an effective strategy in both the prevention and management of breast cancer, and during chemotherapy, physical activity may reduce fatigue, improve quality of life, and increase cardiorespiratory fitness.

This randomized clinical trial will enroll women diagnosed with breast cancer indicated for neoadjuvant or adjuvant chemotherapy. The study aims to characterize the clinical profile of these patients with respect to cardiovascular and functional effects of chemotherapy, and to evaluate an integrated cardio-oncology rehabilitation approach.

The investigators expect to identify the clinical profile of breast cancer patients undergoing chemotherapy and establish associations with the study variables, as well as to assess the effect of a standardized exercise program on the cardiovascular and musculoskeletal systems and quality of life. Based on these results, the study aims to propose a complementary rehabilitation program, to be offered within the public health system, alongside pharmacological treatment during and after completion of the chemotherapy cycle.

調査の概要

詳細な説明

Breast cancer (BC) is highly prevalent worldwide, and in Brazil, particularly in the state of Rio Grande do Sul (RS), it is the leading cause of morbidity and mortality from malignant neoplasms among women. Five-year survival rates exceed 80% in developed countries, whereas in Brazil there is considerable variation across regions and cities. Studies indicate that Porto Alegre, the capital of RS, has one of the highest incidence rates of breast cancer among women under 50 years of age, with 165.5 cases per 100,000 women aged 40 to 49 years.

Several risk factors are associated with the development of breast cancer, including family history of the disease, use of oral contraceptives, obesity, and alcohol consumption. Notably, obesity and alcohol consumption differentially increase the risk of specific molecular subtypes of breast cancer. In addition, physical inactivity and elevated body mass index (BMI) are significant risk factors for breast cancer in postmenopausal women.

Although chemotherapy is essential in oncologic treatment, it is associated with adverse effects on the cardiovascular system. Advances in pharmacologic therapy, together with a greater understanding of disease mechanisms, have led to increased survival and improved health-related well-being among cancer patients. However, this increased survival is accompanied by greater exposure to cardiovascular risk factors and clinically unfavorable outcomes, such as cardiotoxicity caused by chemotherapeutic agents.

Cardiotoxicity, classified as acute, subacute, or chronic, is generally assessed based on changes in left ventricular ejection fraction (LVEF). Nevertheless, there is no universally accepted conceptual definition of chemotherapy-induced cardiotoxicity; definitions vary according to study design, etiology, epidemiology, and prevention strategies.

Adjuvant chemotherapy is used in up to 27% of breast cancer cases. The mechanisms underlying cardiotoxicity and the progression of cardiac dysfunction over time may be explained by: (1) increased myocardial oxidative stress; (2) disruption of mitochondrial calcium homeostasis; (3) impairment of mitochondrial energy metabolism; (4) degradation of ultrastructural proteins; (5) direct DNA damage via inhibition of topoisomerase 2β; and (6) direct cytotoxic effects on cardiac progenitor cells, reducing the heart's reparative capacity following myocardial injury.

Clinical diagnosis of cardiotoxicity cannot be limited to a simple measurement of LVEF. Evidence highlights the importance of evaluating additional outcomes beyond structural changes and reduced LVEF, including cardiac arrhythmias, coronary artery disease, blood biomarkers, and vascular function.

Cardiotoxicity and Vascular Function Endothelial cells are characterized by heterogeneous structure and function, with phenotypic variation according to their location in different organs, tissues, or blood vessel types. Positioned at the interface between blood and tissue, the endothelium plays a key role in the cardiovascular system, including regulation of vascular tone, synthesis and secretion of signaling molecules, and control of hemostasis, coagulation, inflammatory response, and atherogenesis.

Chemotherapeutic agents are generally administered via the systemic circulation. As a result, endothelial cells are among the first to be affected by these drugs, even before cardiac tissue itself. Vascular endothelial health is progressively compromised, with endothelial cells becoming increasingly vulnerable to inflammatory stressors, generation of reactive oxygen species, and reduced nitric oxide bioavailability - factors that directly contribute to the development and progression of atherosclerotic disease.

In addition to inflammatory markers and adhesion molecules, endothelial function can be assessed using brachial artery flow-mediated dilation (FMD), a technique first developed in 1992. This non-invasive method measures brachial artery diameter before and after forearm ischemia induced by inflating a cuff on the distal portion of the arm; FMD is expressed as the percentage increase in brachial artery diameter following release of the ischemic stimulus (reactive hyperemia). This vasodilation is mediated by endothelial release of nitric oxide in response to arterial wall shear stress.

Nagy et al. evaluated 22 patients with a clinical diagnosis of lymphoma treated with doxorubicin (DOX), measuring FMD before and after (at 6, 12, 24, and 48 hours) chemotherapy administration. The study's main finding was a significant reduction in FMD values (9.9±4.4% vs. 6.1±4.6%, P<0.02). In the same line of research, other findings established significant associations between baseline FMD values and changes in LVEF at 3 months (r = 0.433; p = 0.044) and at 6 months (r = 0.581; p = 0.023) among patients who developed cardiotoxicity following anthracycline treatment. Based on these results, the authors suggest that FMD assessment may play an important role as a risk-stratification tool and an early marker of chemotherapy-induced cardiotoxicity.

Breast Cancer and Physical Exercise As noted above, several risk factors are associated with the development of breast cancer, including family history, use of oral contraceptives, obesity, and alcohol consumption, with obesity and alcohol consumption differentially increasing the risk of specific molecular BC subtypes. Physical inactivity and elevated BMI are also significant risk factors for breast cancer in postmenopausal women.

Regular physical exercise has been shown to be an effective strategy in both the prevention and management of breast cancer. During chemotherapy treatment, physical activity may reduce fatigue, improve quality of life, and increase cardiorespiratory fitness. Studies indicate that supervised exercise programs combining aerobic and resistance training are particularly effective in reducing fatigue among women undergoing adjuvant chemotherapy.

After completion of chemotherapy, continued engagement in physical exercise remains equally beneficial. Evidence suggests that regular physical activity is associated with lower all-cause and breast-cancer-specific mortality among survivors. In addition, exercise interventions have been shown to improve self-reported cognitive function, physical fitness, fatigue, and quality of life, and to reduce depressive symptoms in breast cancer patients exposed to chemotherapy.

Given this context, this project proposes to study the clinical profile of women diagnosed with breast cancer with respect to the effects of chemotherapy treatment and the implementation of a physical exercise program on the cardiovascular system and functional capacity, through an integrated cardio-oncology rehabilitation approach, in patients treated within the Brazilian Unified Health System (SUS), cared for at a university hospital or referred from the RS public health network.

Hypotheses Null Hypothesis (H0): In women diagnosed with breast cancer, chemotherapy treatment does not produce statistically significant changes in the following clinical and laboratory outcomes: vascular function (assessed by flow-mediated dilation or ankle-brachial index); cardiac function (assessed by echocardiography or other complementary tests); functional capacity (assessed by the six-minute walk test or VO2 consumption); and inflammatory, endothelial, and cardiovascular biomarkers.

Alternative Hypothesis (H1): In women diagnosed with breast cancer, chemotherapy treatment produces statistically significant changes in the following clinical and laboratory outcomes: reduced vascular function; impaired cardiac function; decreased functional capacity; and altered levels of inflammatory, endothelial, and cardiovascular biomarkers.

研究の種類

介入

入学 (推定)

30

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

  • 名前:Rosane M Nery, PhD
  • 電話番号:+55 51 33597634
  • メール:rnery@hcpa.edu.br

研究場所

    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、ブラジル、90410000
        • 募集
        • Hospital de Clinicas de Porto Alegre
        • 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

  • 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:

  1. Diagnosis of breast cancer
  2. Indicated for chemotherapy treatment
  3. Cardiovascularly stable
  4. Cleared for physical exercise
  5. Willing to participate in the study
  6. Physically able to perform the assessments and training sessions

Exclusion Criteria:

  1. Any decompensated disease that would compromise the ability to perform the training sessions
  2. Prior diagnosis of ischemic heart disease
  3. Prior diagnosis of valvular heart disease
  4. Prior diagnosis of cardiac arrhythmias
  5. Myocarditis within the past 6 months
  6. History of heart failure
  7. LVEF <55% prior to initiation of chemotherapy
  8. Musculoskeletal disorders that limit the ability to perform the exercises
  9. Diagnosis of peripheral arterial occlusive disease within the past 6 months
  10. Ankle-brachial index <0.4
  11. Cognitive impairment that would compromise understanding of study procedures or participation

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:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Exercise Training Group
Participants will undergo a cardio-oncology rehabilitation program with supervised exercise training sessions twice weekly at HCPA's Physical Rehabilitation Service (SFR). Assessments will be performed at baseline and at 3 and 6 months.
Structured, individualized exercise training sessions held twice weekly at HCPA's Physical Rehabilitation Service (SFR), aimed at mitigating chemotherapy-related cardiovascular and functional impairment in breast cancer patients.
介入なし:Control Group
Participants will receive general health and nutritional guidance at the baseline assessment and will maintain usual care, without a structured exercise program. Assessments will be performed at baseline and at 3 and 6 months, following the same schedule as the intervention group.

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
Change in Left Ventricular Ejection Fraction (LVEF)
時間枠:Baseline and 6 months
Left ventricular systolic function assessed by transthoracic echocardiography with strain analysis
Baseline and 6 months
Incidence of Cardiotoxicity
時間枠:Baseline and 6 months
Development of cancer therapy-related cardiac dysfunction, including asymptomatic/subclinical cases, defined by relative decline in global longitudinal strain (GLS) on echocardiography.
Baseline and 6 months
Change in Electrocardiographic Abnormalities and Arrhythmias
時間枠:Baseline and 6 months
ECG findings assessed as part of the echocardiographic evaluation. The ECG will be assessed for the following parameters: heart rate, cardiac rhythm (to identify arrhythmias), PR interval, QRS complex duration and morphology, QT/QTc interval, and ST-segment/T-wave changes.
Baseline and 6 months
Change in Resting Blood Pressure
時間枠:Baseline and 6 months
Measured before cardiopulmonary exercise testing (CPET)
Baseline and 6 months
Change in Blood Pressure During Exercise
時間枠:Baseline and 6 months
Measured during cardiopulmonary exercise testing (CPET)
Baseline and 6 months
Change in Resting Heart Rate
時間枠:Baseline and 6 months
Measured before cardiopulmonary exercise testing (CPET)
Baseline and 6 months
Change in Heart Rate During Exercise
時間枠:Baseline and 6 months
Measured during cardiopulmonary exercise testing (CPET)
Baseline and 6 months
Change in Peak Oxygen Consumption (VO2 Peak)
時間枠:Baseline and 6 months
Measured during cardiopulmonary exercise testing (CPET)
Baseline and 6 months
Fatigue Pictogram (Mota, Pimenta, Fitch, 2009)
時間枠:Baseline, 3 months, and 6 months
This pictorial instrument assesses fatigue intensity and fatigue interference with usual activities, each rated on a scale from 1 to 5, where higher scores indicate worse outcomes (greater fatigue intensity and greater interference with activities, respectively).
Baseline, 3 months, and 6 months
Modified Borg CR-10 Scale (Category-Ratio 10)
時間枠:Baseline, 3 months, and 6 months
This scale ranges from 0 (no exertion/dyspnea at all) to 10 (maximal/very, very severe exertion or dyspnea), where higher scores indicate worse perceived exertion or breathlessness.
Baseline, 3 months, and 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Troponin
時間枠:Baseline and 6 months
Blood biomarker (troponin)
Baseline and 6 months
Change in BNP/NT-proBNP
時間枠:Baseline and 6 months
Blood biomarker (BNP/NT-proBNP)
Baseline and 6 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
時間枠:Baseline and 6 months
Blood biomarker (hs-CRP)
Baseline and 6 months
Change in TNF-alpha
時間枠:Baseline and 6 months
TNF-alpha
Baseline and 6 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23)
時間枠:Baseline and 6 months
This is a supplementary, disease-specific module used alongside the EORTC QLQ-C30. All scales and single-item measures are scored from 0 to 100 after linear transformation, following the EORTC QLQ-C30 Scoring Manual scoring algorithm. For the functional scales (Body Image, Sexual Functioning, Sexual Enjoyment, Future Perspective), higher scores indicate better functioning (better outcome). For the symptom scales/items (Systemic Therapy Side Effects, Breast Symptoms, Arm Symptoms, Upset by Hair Loss), higher scores indicate greater symptom burden (worse outcome)."
Baseline and 6 months
Change in Lean Body Mass
時間枠:Baseline and 6 months
Bioelectrical impedance analysis
Baseline and 6 months
Change in Body Fat
時間枠:Baseline and 6 months
Bioelectrical impedance analysis
Baseline and 6 months
Change in Muscle Mass Index
時間枠:Baseline and 6 months
Bioelectrical impedance analysis
Baseline and 6 months
Change in Hand Grip Strength
時間枠:Baseline and 6 months
Bilateral hand grip strength assessed by dynamometry
Baseline and 6 months
Rehabilitation Program Adherence
時間枠:Throughout the 6-month study period
Percentage of prescribed exercise sessions attended
Throughout the 6-month study period
Reduction in Cardiovascular Adverse Events During Treatment
時間枠:Throughout the 6-month study period
Number of adverse events during treatment
Throughout the 6-month study period
Change in Ankle-Brachial Index (ABI)
時間枠:Baseline, 3 months, and 6 months
Doppler ultrasound ankle-brachial index
Baseline, 3 months, and 6 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。

捜査官

  • 主任研究者:Rosane M Nery, PhD、Hospital de Clinicas de Porto Alegre

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (実際)

2025年12月1日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年7月29日

QC基準を満たした最初の提出物

2026年9月14日

最初の投稿 (実際)

2026年9月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月16日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Dipe - 20250191
  • 97992026.9.0000.5327 (その他の識別子:Plataforma Brasil)

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?

いいえ

IPD プランの説明

The study protocol establishes that participant data confidentiality and privacy will be maintained in accordance with Brazilian data protection regulations (LGPD, Law No. 13,709/2018) and national research ethics resolutions (CNS 466/2012, CNS 510/2016), with no provision in the approved protocol or informed consent form for sharing individual participant data with external researchers.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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