Cardio-Oncology Rehabilitation in Breast Cancer Patients Undergoing Chemotherapy
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
入学 (推定)
段階
- 適用できない
連絡先と場所
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
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90410000
- 募集
- Hospital de Clinicas de Porto Alegre
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コンタクト:
- Rosane M Nery, PhD
- 電話番号:+55 51 33597634
- メール:rnery@hcpa.edu.br
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-
参加基準
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
説明
Inclusion Criteria:
- Diagnosis of breast cancer
- Indicated for chemotherapy treatment
- Cardiovascularly stable
- Cleared for physical exercise
- Willing to participate in the study
- Physically able to perform the assessments and training sessions
Exclusion Criteria:
- Any decompensated disease that would compromise the ability to perform the training sessions
- Prior diagnosis of ischemic heart disease
- Prior diagnosis of valvular heart disease
- Prior diagnosis of cardiac arrhythmias
- Myocarditis within the past 6 months
- History of heart failure
- LVEF <55% prior to initiation of chemotherapy
- Musculoskeletal disorders that limit the ability to perform the exercises
- Diagnosis of peripheral arterial occlusive disease within the past 6 months
- Ankle-brachial index <0.4
- Cognitive impairment that would compromise understanding of study procedures or participation
研究計画
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 |
|---|---|
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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.
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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.
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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.
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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 |
|---|---|---|
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Change in Left Ventricular Ejection Fraction (LVEF)
時間枠:Baseline and 6 months
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Left ventricular systolic function assessed by transthoracic echocardiography with strain analysis
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Baseline and 6 months
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Incidence of Cardiotoxicity
時間枠:Baseline and 6 months
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Development of cancer therapy-related cardiac dysfunction, including asymptomatic/subclinical cases, defined by relative decline in global longitudinal strain (GLS) on echocardiography.
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Baseline and 6 months
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Change in Electrocardiographic Abnormalities and Arrhythmias
時間枠:Baseline and 6 months
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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.
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Baseline and 6 months
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Change in Resting Blood Pressure
時間枠:Baseline and 6 months
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Measured before cardiopulmonary exercise testing (CPET)
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Baseline and 6 months
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Change in Blood Pressure During Exercise
時間枠:Baseline and 6 months
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Measured during cardiopulmonary exercise testing (CPET)
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Baseline and 6 months
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Change in Resting Heart Rate
時間枠:Baseline and 6 months
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Measured before cardiopulmonary exercise testing (CPET)
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Baseline and 6 months
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Change in Heart Rate During Exercise
時間枠:Baseline and 6 months
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Measured during cardiopulmonary exercise testing (CPET)
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Baseline and 6 months
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Change in Peak Oxygen Consumption (VO2 Peak)
時間枠:Baseline and 6 months
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Measured during cardiopulmonary exercise testing (CPET)
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Baseline and 6 months
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Fatigue Pictogram (Mota, Pimenta, Fitch, 2009)
時間枠:Baseline, 3 months, and 6 months
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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).
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Baseline, 3 months, and 6 months
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Modified Borg CR-10 Scale (Category-Ratio 10)
時間枠:Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Troponin
時間枠:Baseline and 6 months
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Blood biomarker (troponin)
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Baseline and 6 months
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Change in BNP/NT-proBNP
時間枠:Baseline and 6 months
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Blood biomarker (BNP/NT-proBNP)
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Baseline and 6 months
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Change in High-Sensitivity C-Reactive Protein (hs-CRP)
時間枠:Baseline and 6 months
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Blood biomarker (hs-CRP)
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Baseline and 6 months
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Change in TNF-alpha
時間枠:Baseline and 6 months
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TNF-alpha
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Baseline and 6 months
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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
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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)."
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Baseline and 6 months
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Change in Lean Body Mass
時間枠:Baseline and 6 months
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Bioelectrical impedance analysis
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Baseline and 6 months
|
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Change in Body Fat
時間枠:Baseline and 6 months
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Bioelectrical impedance analysis
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Baseline and 6 months
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Change in Muscle Mass Index
時間枠:Baseline and 6 months
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Bioelectrical impedance analysis
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Baseline and 6 months
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Change in Hand Grip Strength
時間枠:Baseline and 6 months
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Bilateral hand grip strength assessed by dynamometry
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Baseline and 6 months
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Rehabilitation Program Adherence
時間枠:Throughout the 6-month study period
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Percentage of prescribed exercise sessions attended
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Throughout the 6-month study period
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Reduction in Cardiovascular Adverse Events During Treatment
時間枠:Throughout the 6-month study period
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Number of adverse events during treatment
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Throughout the 6-month study period
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Change in Ankle-Brachial Index (ABI)
時間枠:Baseline, 3 months, and 6 months
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Doppler ultrasound ankle-brachial index
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Baseline, 3 months, and 6 months
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協力者と研究者
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
一般刊行物
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研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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