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Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568161
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Universidade Federal Fluminense
Hospital Israelita Albert Einstein
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiotoxicity Cardiovascular Disease Neurovascular Disorder Endothelial Disfunction Breast Cancer 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chronic Effect of Doxorubicin and Cyclophosphamide on Neurovascular Control and Blood Pressure in Women in Adjuvant Treatment for Breast Neoplasia
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : September 3, 2021
Estimated Study Completion Date : September 3, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568161


Contacts
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Contact: Raphaela VR Groehs, PhD 551126615699 rapha_vilar@hotmail.com
Contact: Ursula Urias, PhD 551126615699 uurias@usp.br

Locations
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Brazil
Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-900
Contact: Raphaela VR Groehs, PhD    551126615699    rapha_vilar@hotmail.com   
Contact: Ursula Urias, PhD    551126615699    uurias@usp.br   
Principal Investigator: Carlos Eduardo Negrao, PHD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Universidade Federal Fluminense
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: Carlos E Negrao, PhD Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
Publications:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04568161    
Other Study ID Numbers: Breast Cancer Chemotherapy
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Chemotherapy
Endothelial Disfunction
Muscle Sympathetic Nerve Activity
Blood Pressure
Additional relevant MeSH terms:
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Cardiovascular Diseases
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists