Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

Not Applicable

Completed

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

• Registration Number: NCT04568161
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Primary Completion: 2022-09-03
• Status Verified: 2025-03
• Study Completion: 2025-03-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pre and post chemotherapy assessments	Physical Characteristics	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Muscular Sympathetic Nervous Activity	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Cardiac Function	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Heart rate	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Blood pressure	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Blood Assessments	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Muscle blood flow	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Endothelium-dependent vascular function	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Vascular intima-media thickness	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Physical Capacity	The patients will be assessed before and after chemotherapy treatment.
pre and post chemotherapy assessments	Anthracycline & Cyclophosphamide treatment scheme	The patients will be assessed before and after chemotherapy treatment.

Primary Outcome Measures

Name	Time	Method
Muscle sympathetic nerve activity	15-20 days after the end of AC regimen	Change in muscular sympathetic nerve activity measured by microneurography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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