Skip to main content
OpenTrials
Completed

NCT Number: NCT04568161

Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiotoxicity Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Disease Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Endothelial Disfunction Heart Diseases Neoplasms Neoplasms by Site Neurovascular Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Characteristics

Procedure

Body weight, height and waist circumference

Muscular Sympathetic Nervous Activity

Procedure

Microneurography technique.

Cardiac Function

Diagnostic Test

Echocardiography.

Heart rate

Diagnostic Test

Electrocardiography

blood pressure

Diagnostic Test

Non-invasive photoplethysmography.

Blood Assessments

Diagnostic Test

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.

Muscle blood flow

Diagnostic Test

Venous occlusion plethysmography

Endothelium-dependent vascular function

Diagnostic Test

Brachial ultrasound

Vascular intima-media thickness

Diagnostic Test

Carotid ultrasound

Physical Capacity

Diagnostic Test

Cardiopulmonary exercise test

Anthracycline & Cyclophosphamide treatment scheme

Drug

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

Primary outcomes

  1. Muscle sympathetic nerve activity

    Time frame: 15-20 days after the end of AC regimen

    Change in muscular sympathetic nerve activity measured by microneurography

Secondary outcomes

  1. Muscle blood flow

    Time frame: 15-20 days after the end of AC regimen

    Change in muscle blood flow measured by venous oclusion plethysmography

  2. Blood Pressure

    Time frame: 15-20 days after the and of AC regimen

    Change in blood pressure measured by finometer

  3. Physical capacity

    Time frame: 15-20 days after the end of AC regimen

    Change in physical capacity measured by cardiopulmonary exercise test

  4. Cardiac Function Impairment

    Time frame: 15-20 days after the end of AC regimen

    Change in cardiac function measured by echocardiography

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Hospital Israelita Albert Einstein
  • Universidade Federal Fluminense

Registry information

Official study title

Chronic Effect of Doxorubicin and Cyclophosphamide on Neurovascular Control and Blood Pressure in Women in Adjuvant Treatment for Breast Neoplasia

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Sep 29, 2020
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.