An interventional study of Physical Characteristics and Muscular Sympathetic Nervous Activity in Cardiotoxicity, Cardiovascular Disease and Neurovascular Disorder, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Diagnostic
The present study aims to investigate the chronic effect of treatment with doxorubicin and cyclophosphamide on neurovascular control and blood pressure in women undergoing adjuvant treatment for breast cancer.
The development of new drugs and different adjuvant therapeutic regimens, based on the combination of anthracycline (A) and cyclophosphamide (C), have contributed greatly to improve survival rate in breast cancer patients. Despite the clinical benefits of this therapy, AC treatment can cause cardiovascular acute and chronic changes. In a recent investigation, we observed that an acute AC chemotherapy session increases sympathetic nervous activity and blood pressure in patients with breast cancer.
The present study aims to investigate the chronic effects of AC regimen on sympathetic nervous activity, peripheral vasoconstriction, endothelial microparticles and blood pressure, in women with breast cancer.
4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 15 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The patients will be assessed before and after chemotherapy treatment.
Procedure: Physical Characteristics · Procedure: Muscular Sympathetic Nervous Activity · Diagnostic Test: Cardiac Function · Diagnostic Test: Heart rate · Diagnostic Test: Blood pressure · Diagnostic Test: Blood Assessments · Diagnostic Test: Muscle blood flow · Diagnostic Test: Endothelium-dependent vascular function · Diagnostic Test: Vascular intima-media thickness · Diagnostic Test: Physical Capacity · Drug: Anthracycline & Cyclophosphamide treatment scheme
Body weight, height and waist circumference
Microneurography technique.
Echocardiography.
Electrocardiography
Non-invasive photoplethysmography.
Serum and Plasma will be extracted by centrifugation. Endothelial microparticles by flow cytometry Interleukin-6 and tumor necrosis factor α by ELISA, High-sensitive reactive serum C-reactive protein by immunoturbidimetric assay, NT- ProBNP According to Central Laboratory, Hospital das Clinicas, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo. Endothelin-1 by immunoenzymatic method Nitric oxide by gas chemiluminescence Lipoperoxidation by fluorimetry Carbonyl by spectrophotometer, and Superoxide Dismutase (SOD) by colorimetry.
Venous occlusion plethysmography
Brachial ultrasound
Carotid ultrasound
Cardiopulmonary exercise test
Four session of intravenous (in bolus) infusion of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 with an interval of 21 days between sessions.
Muscle sympathetic nerve activity
Change in muscular sympathetic nerve activity measured by microneurography
Time frame: 15-20 days after the end of AC regimen
Muscle blood flow
Change in muscle blood flow measured by venous oclusion plethysmography
Time frame: 15-20 days after the end of AC regimen
Blood Pressure
Change in blood pressure measured by finometer
Time frame: 15-20 days after the and of AC regimen
Physical capacity
Change in physical capacity measured by cardiopulmonary exercise test
Time frame: 15-20 days after the end of AC regimen
Cardiac Function Impairment
Change in cardiac function measured by echocardiography
Time frame: 15-20 days after the end of AC regimen
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital