Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

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.

Conditions

• Cardiotoxicity
• Cardiovascular Disease
• Neurovascular Disorder
• Endothelial Disfunction
• Breast 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.

Sponsors & Collaborators

• Universidade Federal Fluminense

  collaborator OTHER

• Hospital Israelita Albert Einstein

  collaborator OTHER

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Carlos E Negrao, PhD · Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

45 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-03

Primary Completion

2022-09-03

Completion

2025-03-03

Countries

• Brazil

Study Locations