Cardiotoxicity, Cardiovascular Disease, Neurovascular Disorder, Endothelial Disfunction, Breast Cancer
Conditions
Keywords
Chemotherapy, Endothelial Disfunction, Muscle Sympathetic Nerve Activity, Blood Pressure
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPhysical Characteristics
Body weight, height and waist circumference
PROCEDUREMuscular Sympathetic Nervous Activity
Microneurography technique.
DIAGNOSTIC_TESTBlood Assessments
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.
DIAGNOSTIC_TESTCardiac Function
Echocardiography.
DIAGNOSTIC_TESTHeart rate
Electrocardiography
DIAGNOSTIC_TESTBlood pressure
Non-invasive photoplethysmography.
DIAGNOSTIC_TESTMuscle blood flow
Venous occlusion plethysmography
DIAGNOSTIC_TESTEndothelium-dependent vascular function
Brachial ultrasound
DIAGNOSTIC_TESTVascular intima-media thickness
Carotid ultrasound
DIAGNOSTIC_TESTPhysical Capacity
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.
Sponsors
Universidade Federal Fluminense
Hospital Israelita Albert Einstein
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of stage II-III breast cancer * starting adjuvant chemotherapy
Exclusion criteria
* metastatic disease, * hypercholesterolemia, diabetes, * hypertension, * severe lymphedema, * organic disorders (renal failure, heart failure and chronic liver disease), * obesity (BMI\> 30) and, * who are under pharmacological treatment with statins, angiotensin-converting enzyme inhibitors, losartan potassium, beta blockers or antioxidants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle sympathetic nerve activity | 15-20 days after the end of AC regimen | Change in muscular sympathetic nerve activity measured by microneurography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle blood flow | 15-20 days after the end of AC regimen | Change in muscle blood flow measured by venous oclusion plethysmography |
| Blood Pressure | 15-20 days after the and of AC regimen | Change in blood pressure measured by finometer |
| Physical capacity | 15-20 days after the end of AC regimen | Change in physical capacity measured by cardiopulmonary exercise test |
| Cardiac Function Impairment | 15-20 days after the end of AC regimen | Change in cardiac function measured by echocardiography |
Countries
Brazil
Outcome results
None listed