[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656245":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":81,"studyPopulation":74,"armGroups":82,"interventions":93,"overallOfficials":99,"centralContacts":103,"locations":108,"responsibleParty":124,"collaborators":74,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":74,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":74,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":110,"whyStopped":74,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":38,"otherOutcomes":74},[9,13,16,19,22,25,27,29,31,35],{"measure":10,"description":11,"timeFrame":12},"Change in Left Ventricular Ejection Fraction (LVEF)","Left ventricular systolic function assessed by transthoracic echocardiography with strain analysis","Baseline and 6 months",{"measure":14,"description":15,"timeFrame":12},"Incidence of Cardiotoxicity","Development of cancer therapy-related cardiac dysfunction, including asymptomatic\u002Fsubclinical cases, defined by relative decline in global longitudinal strain (GLS) on echocardiography.",{"measure":17,"description":18,"timeFrame":12},"Change in Electrocardiographic Abnormalities and Arrhythmias","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\u002FQTc interval, and ST-segment\u002FT-wave changes.",{"measure":20,"description":21,"timeFrame":12},"Change in Resting Blood Pressure","Measured before cardiopulmonary exercise testing (CPET)",{"measure":23,"description":24,"timeFrame":12},"Change in Blood Pressure During Exercise","Measured during cardiopulmonary exercise testing (CPET)",{"measure":26,"description":21,"timeFrame":12},"Change in Resting Heart Rate",{"measure":28,"description":24,"timeFrame":12},"Change in Heart Rate During Exercise",{"measure":30,"description":24,"timeFrame":12},"Change in Peak Oxygen Consumption (VO2 Peak)",{"measure":32,"description":33,"timeFrame":34},"Fatigue Pictogram (Mota, Pimenta, Fitch, 2009)","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",{"measure":36,"description":37,"timeFrame":34},"Modified Borg CR-10 Scale (Category-Ratio 10)","This scale ranges from 0 (no exertion\u002Fdyspnea at all) to 10 (maximal\u002Fvery, very severe exertion or dyspnea), where higher scores indicate worse perceived exertion or breathlessness.",[39,42,45,48,51,54,57,59,61,64,68,71],{"measure":40,"description":41,"timeFrame":12},"Change in Troponin","Blood biomarker (troponin)",{"measure":43,"description":44,"timeFrame":12},"Change in BNP\u002FNT-proBNP","Blood biomarker (BNP\u002FNT-proBNP)",{"measure":46,"description":47,"timeFrame":12},"Change in High-Sensitivity C-Reactive Protein (hs-CRP)","Blood biomarker (hs-CRP)",{"measure":49,"description":50,"timeFrame":12},"Change in TNF-alpha","TNF-alpha",{"measure":52,"description":53,"timeFrame":12},"European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23)","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\u002Fitems (Systemic Therapy Side Effects, Breast Symptoms, Arm Symptoms, Upset by Hair Loss), higher scores indicate greater symptom burden (worse outcome).\"",{"measure":55,"description":56,"timeFrame":12},"Change in Lean Body Mass","Bioelectrical impedance analysis",{"measure":58,"description":56,"timeFrame":12},"Change in Body Fat",{"measure":60,"description":56,"timeFrame":12},"Change in Muscle Mass Index",{"measure":62,"description":63,"timeFrame":12},"Change in Hand Grip Strength","Bilateral hand grip strength assessed by dynamometry",{"measure":65,"description":66,"timeFrame":67},"Rehabilitation Program Adherence","Percentage of prescribed exercise sessions attended","Throughout the 6-month study period",{"measure":69,"description":70,"timeFrame":67},"Reduction in Cardiovascular Adverse Events During Treatment","Number of adverse events during treatment",{"measure":72,"description":73,"timeFrame":34},"Change in Ankle-Brachial Index (ABI)","Doppler ultrasound ankle-brachial index",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":74,"primaryPurpose":78,"observationalModel":74,"timePerspective":74,"maskingInfo":79},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":80,"maskingDescription":74,"whoMasked":74},"NONE","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.\n\nSeveral 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.\n\nAlthough 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.\n\nCardiotoxicity, 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.\n\nAdjuvant 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.\n\nClinical 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.\n\nCardiotoxicity 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.\n\nChemotherapeutic 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.\n\nIn 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.\n\nNagy 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\\\u003C0.02). 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.\n\nBreast 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.\n\nRegular 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.\n\nAfter 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.\n\nGiven 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.\n\nHypotheses 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.\n\nAlternative 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.",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"Exercise Training Group","EXPERIMENTAL","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.",[88],"Behavioral: Cardio-Oncology Exercise Rehabilitation Program",{"label":90,"type":91,"description":92,"interventionNames":74},"Control Group","NO_INTERVENTION","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.",[94],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":74},"BEHAVIORAL","Cardio-Oncology Exercise Rehabilitation Program","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.",[84],[100],{"name":101,"affiliation":5,"role":102},"Rosane M Nery, PhD","PRINCIPAL_INVESTIGATOR",[104],{"name":101,"role":105,"phone":106,"phoneExt":74,"email":107},"CONTACT","+55 51 33597634","rnery@hcpa.edu.br",[109],{"facility":5,"status":110,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"RECRUITING","Porto Alegre","Rio Grande do Sul","90410000","Brazil","BR",{"type":117,"coordinates":118},"Point",[119,120],-51.23019,-30.03283,{"lat":120,"lon":119},[123],{"name":101,"role":105,"phone":106,"phoneExt":74,"email":107},{"type":125,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR","100656245","cardio-oncology-rehabilitation-in-breast-cancer-patients-undergoing-chemotherapy-100656245",false,"NCT07823660","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","Inclusion Criteria:\n\n1. Diagnosis of breast cancer\n2. Indicated for chemotherapy treatment\n3. Cardiovascularly stable\n4. Cleared for physical exercise\n5. Willing to participate in the study\n6. Physically able to perform the assessments and training sessions\n\nExclusion Criteria:\n\n1. Any decompensated disease that would compromise the ability to perform the training sessions\n2. Prior diagnosis of ischemic heart disease\n3. Prior diagnosis of valvular heart disease\n4. Prior diagnosis of cardiac arrhythmias\n5. Myocarditis within the past 6 months\n6. History of heart failure\n7. LVEF \\\u003C55% prior to initiation of chemotherapy\n8. Musculoskeletal disorders that limit the ability to perform the exercises\n9. Diagnosis of peripheral arterial occlusive disease within the past 6 months\n10. Ankle-brachial index \\\u003C0.4\n11. Cognitive impairment that would compromise understanding of study procedures or participation","FEMALE","18 Years","65 Years",{"count":137,"type":138},30,"ESTIMATED","INTERVENTIONAL",[141],"NA","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.\n\nThis 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.\n\nThe 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.",[144],"Breast Cancer",[146,147,148],"Breast cancer","Chemotherapy","Cardio-oncology rehabilitation","2026-09-14",{"date":151,"type":152},"2026-09-16","ACTUAL",{"date":154,"type":152},"2025-12-01",{"date":156,"type":138},"2027-08",{"name":5,"class":6},1]