Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

November 29, 2023 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ursula Urias, PhD
  • Phone Number: 551126615699
  • Email: uurias@usp.br

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Recruiting
        • Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
        • Principal Investigator:
          • Carlos Eduardo Negrao, PHD
        • Contact:
        • Contact:
          • Ursula Urias, PhD
          • Phone Number: 551126615699
          • Email: uurias@usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle sympathetic nerve activity
Time Frame: 15-20 days after the end of AC regimen
Change in muscular sympathetic nerve activity measured by microneurography
15-20 days after the end of AC regimen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle blood flow
Time Frame: 15-20 days after the end of AC regimen
Change in muscle blood flow measured by venous oclusion plethysmography
15-20 days after the end of AC regimen
Blood Pressure
Time Frame: 15-20 days after the and of AC regimen
Change in blood pressure measured by finometer
15-20 days after the and of AC regimen
Physical capacity
Time Frame: 15-20 days after the end of AC regimen
Change in physical capacity measured by cardiopulmonary exercise test
15-20 days after the end of AC regimen
Cardiac Function Impairment
Time Frame: 15-20 days after the end of AC regimen
Change in cardiac function measured by echocardiography
15-20 days after the end of AC regimen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Hospital Israelita Albert Einstein
Universidade Federal Fluminense

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

September 3, 2022

Study Completion (Estimated)

March 3, 2024

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast Cancer Chemotherapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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