Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

NCT04568161 | Completed

• 1 other identifier: Breast Cancer Chemotherapy
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Cardiovascular Disease; Neurovascular Disorder; Endothelial Disfunction; Breast Cancer

Keywords

Chemotherapy; Endothelial Disfunction; Muscle Sympathetic Nerve Activity; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Muscle sympathetic nerve activity

  Change in muscular sympathetic nerve activity measured by microneurography

  15-20 days after the end of AC regimen

Secondary Outcomes (4)

• Muscle blood flow

  15-20 days after the end of AC regimen

• Blood Pressure

  15-20 days after the and of AC regimen

• Physical capacity

  15-20 days after the end of AC regimen

• Cardiac Function Impairment

  15-20 days after the end of AC regimen

Study Arms (1)

pre and post chemotherapy assessments

EXPERIMENTAL

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

Interventions

Physical Characteristics PROCEDURE

Body weight, height and waist circumference

pre and post chemotherapy assessments

Muscular Sympathetic Nervous Activity PROCEDURE

Microneurography technique.

pre and post chemotherapy assessments

Cardiac Function DIAGNOSTIC_TEST

Echocardiography.

pre and post chemotherapy assessments

Heart rate DIAGNOSTIC_TEST

Electrocardiography

pre and post chemotherapy assessments

Blood pressure DIAGNOSTIC_TEST

Non-invasive photoplethysmography.

pre and post chemotherapy assessments

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.

pre and post chemotherapy assessments

Muscle blood flow DIAGNOSTIC_TEST

Venous occlusion plethysmography

pre and post chemotherapy assessments

Endothelium-dependent vascular function DIAGNOSTIC_TEST

Brachial ultrasound

pre and post chemotherapy assessments

Vascular intima-media thickness DIAGNOSTIC_TEST

Carotid ultrasound

pre and post chemotherapy assessments

Physical Capacity DIAGNOSTIC_TEST

Cardiopulmonary exercise test

pre and post chemotherapy assessments

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.

pre and post chemotherapy assessments

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of stage II-III breast cancer
• starting adjuvant chemotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Universidade Federal Fluminense: collaborator
• Hospital Israelita Albert Einstein: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (14)

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MeSH Terms

Conditions

Cardiotoxicity; Cardiovascular Diseases; Breast Neoplasms

Interventions

Heart Function Tests; Heart Rate; Blood Pressure; Anthracyclines

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Vital Signs; Physical Examination; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Carlos E Negrao, PhD

  Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 29, 2020
• Study Start: August 3, 2020
• Primary Completion: September 3, 2022
• Study Completion: March 3, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)