Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

University of Sao Paulo General Hospital

Status: Completed

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

Treatments: Procedure: Muscular Sympathetic Nervous Activity; Diagnostic Test: Physical Capacity; Drug: Anthracycline & Cyclophosphamide treatment scheme; Diagnostic Test: Blood pressure; Diagnostic Test: Endothelium-dependent vascular function; Diagnostic Test: Vascular intima-media thickness; Diagnostic Test: Heart rate; Diagnostic Test: Cardiac Function; Diagnostic Test: Muscle blood flow; Diagnostic Test: Blood Assessments; Procedure: Physical Characteristics

Study type: Interventional

Funder types: Other

Identifiers

NCT04568161

Breast Cancer Chemotherapy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

pre and post chemotherapy assessments

Experimental group

Description:

The patients will be assessed before and after chemotherapy treatment.

Treatment:

Procedure: Physical Characteristics

Diagnostic Test: Blood Assessments

Diagnostic Test: Muscle blood flow

Diagnostic Test: Cardiac Function

Diagnostic Test: Vascular intima-media thickness

Diagnostic Test: Endothelium-dependent vascular function

Diagnostic Test: Heart rate

Diagnostic Test: Blood pressure

Drug: Anthracycline & Cyclophosphamide treatment scheme

Diagnostic Test: Physical Capacity

Procedure: Muscular Sympathetic Nervous Activity