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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Rosane M Nery, PhD
- Numero di telefono: +55 51 33597634
- Email: rnery@hcpa.edu.br
Luoghi di studio
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasile, 90410000
- Reclutamento
- Hospital de Clinicas de Porto Alegre
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Contatto:
- Rosane M Nery, PhD
- Numero di telefono: +55 51 33597634
- Email: rnery@hcpa.edu.br
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Left Ventricular Ejection Fraction (LVEF)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Troponin
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Rosane M Nery, PhD, Hospital de Clinicas de Porto Alegre
Pubblicazioni e link utili
Pubblicazioni generali
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- Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
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- Curigliano G, Cardinale D, Dent S, Criscitiello C, Aseyev O, Lenihan D, Cipolla CM. Cardiotoxicity of anticancer treatments: Epidemiology, detection, and management. CA Cancer J Clin. 2016 Jul;66(4):309-25. doi: 10.3322/caac.21341. Epub 2016 Feb 26.
- Spei ME, Samoli E, Bravi F, La Vecchia C, Bamia C, Benetou V. Physical activity in breast cancer survivors: A systematic review and meta-analysis on overall and breast cancer survival. Breast. 2019 Apr;44:144-152. doi: 10.1016/j.breast.2019.02.001. Epub 2019 Feb 12.
- Koevoets EW, Schagen SB, de Ruiter MB, Geerlings MI, Witlox L, van der Wall E, Stuiver MM, Sonke GS, Velthuis MJ, Jobsen JJ, Menke-Pluijmers MBE, Goker E, van der Pol CC, Bos MEMM, Tick LW, van Holsteijn NA, van der Palen J, May AM, Monninkhof EM; PAM study group. Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer: a randomized controlled trial (PAM study). Breast Cancer Res. 2022 May 26;24(1):36. doi: 10.1186/s13058-022-01530-2.
- Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
- Renaud P, Blondin JP. The stress of Stroop performance: physiological and emotional responses to color-word interference, task pacing, and pacing speed. Int J Psychophysiol. 1997 Sep;27(2):87-97. doi: 10.1016/s0167-8760(97)00049-4.
- Medeiros Torres D, Jorge Koifman R, da Silva Santos S. Impact on fatigue of different types of physical exercise during adjuvant chemotherapy and radiotherapy in breast cancer: systematic review and meta-analysis. Support Care Cancer. 2022 Jun;30(6):4651-4662. doi: 10.1007/s00520-022-06809-w. Epub 2022 Jan 22.
- Joaquim A, Leao I, Antunes P, Capela A, Viamonte S, Alves AJ, Helguero LA, Macedo A. Impact of physical exercise programs in breast cancer survivors on health-related quality of life, physical fitness, and body composition: Evidence from systematic reviews and meta-analyses. Front Oncol. 2022 Dec 9;12:955505. doi: 10.3389/fonc.2022.955505. eCollection 2022.
- Nagy L, Szabo F, Ivanyi J, Nemeth L, Kovacs GL, Palatka J, Tarjan J, Toth K, Roth E. A method for detection of doxorubicin-induced cardiotoxicity: Flow-mediated vasodilation of the brachial artery. Exp Clin Cardiol. 2001 Summer;6(2):87-92.
- Luu AZ, Chowdhury B, Al-Omran M, Teoh H, Hess DA, Verma S. Role of Endothelium in Doxorubicin-Induced Cardiomyopathy. JACC Basic Transl Sci. 2018 Dec 31;3(6):861-870. doi: 10.1016/j.jacbts.2018.06.005. eCollection 2018 Dec.
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- Monsuez JJ, Charniot JC, Vignat N, Artigou JY. Cardiac side-effects of cancer chemotherapy. Int J Cardiol. 2010 Sep 24;144(1):3-15. doi: 10.1016/j.ijcard.2010.03.003. Epub 2010 Apr 18.
- Borghesan DH, Agnolo CM, Gravena AA, Demitto Mde O, Lopes TC, Carvalho MD, Pelloso SM. Risk Factors for Breast Cancer in Postmenopausal Women in Brazil. Asian Pac J Cancer Prev. 2016;17(7):3587-93.
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- Dipe - 20250191
- 97992026.9.0000.5327 (Altro identificatore: Plataforma Brasil)
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