Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 3, 2020

Primary Completion Date

September 3, 2022

Study Completion Date

March 3, 2025

Conditions
CardiotoxicityCardiovascular DiseaseNeurovascular DisorderEndothelial DisfunctionBreast Cancer
Interventions
PROCEDURE

Physical Characteristics

Body weight, height and waist circumference

PROCEDURE

Muscular Sympathetic Nervous Activity

Microneurography technique.

DIAGNOSTIC_TEST

Cardiac Function

Echocardiography.

DIAGNOSTIC_TEST

Heart rate

Electrocardiography

DIAGNOSTIC_TEST

Blood pressure

Non-invasive photoplethysmography.

DIAGNOSTIC_TEST

Blood 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_TEST

Muscle blood flow

Venous occlusion plethysmography

DIAGNOSTIC_TEST

Endothelium-dependent vascular function

Brachial ultrasound

DIAGNOSTIC_TEST

Vascular intima-media thickness

Carotid ultrasound

DIAGNOSTIC_TEST

Physical Capacity

Cardiopulmonary exercise test

DRUG

Anthracycline & Cyclophosphamide treatment scheme

Four session of intravenous (in bolus) infusion of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 with an interval of 21 days between sessions.

Trial Locations (1)

05403-900

Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo

All Listed Sponsors
collaborator

Universidade Federal Fluminense

OTHER

collaborator

Hospital Israelita Albert Einstein

OTHER

lead

University of Sao Paulo General Hospital

OTHER

NCT04568161 - Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses | Biotech Hunter | Biotech Hunter