NCT04568161

Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-09-03
• Completion: 2025-03-03
• First posted: 2020-09-29
• Last updated: 2025-04-03

Locations

1 site across 1 country: Brazil