ANTthracycline-induced Inflammation and OXidative Stress: 10-year Follow-up

NCT07680855 | Completed

• 1 other identifier: CEC-SSMO-97-2021
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn about the long-term effects of anthracycline chemotherapy on inflammation, oxidative stress, and heart function in adult women with breast cancer. The main questions it aims to answer are:

1. 1.Do inflammatory cytokine levels change after anthracycline chemotherapy and remain altered many years after treatment?
2. 2.Are long-term markers of oxidative stress and antioxidant capacity associated with changes in heart structure or function after anthracycline exposure?
3. 3.Provide blood samples for the measurement of inflammatory cytokines and oxidative stress-related biomarkers
4. 4.Undergo a clinical cardiovascular evaluation
5. 5.Receive a transthoracic echocardiogram to assess heart function, including measures of systolic and diastolic function and myocardial deformation
6. 6.Participate in a long-term follow-up assessment approximately 10 years after their initial cancer treatment

Conditions

Cardiotoxicity; Breast Cancer; Anthracycline Related Cardiotoxicity in Breast Cancer

Keywords

Cardio-oncology; Anthracycline chemotherapy; Echocardiography; Global longitudinal strain; Oxidative stress; Antioxidant capacity; Inflammatory cytokines; Subclinical cardiotoxicity; Long-term follow-up; Breast cancer survivors

Outcome Measures

Primary Outcomes (2)

• Change in left ventricular ejection fraction from baseline to 10-year follow-up

  Assessment of left ventricular systolic function by biplane Simpson method using transthoracic echocardiography. Left ventricular ejection fraction (LVEF) was measured at baseline (7 days before the first cycle of anthracycline chemotherapy) and at the 10-year follow-up.

  From baseline (7 days before the first anthracycline chemotherapy cycle) to 10 years after completion of chemotherapy

• Change in left ventricular filling pressure (E/e' ratio) from baseline to 10-year follow-up

  Assessment of left ventricular diastolic function using the average E/e' ratio obtained by transthoracic echocardiography. Measurements were performed at baseline (7 days before the first cycle of anthracycline chemotherapy) and at the 10-year follow-up.

  From baseline (7 days before the first anthracycline chemotherapy cycle) to 10 years after completion of chemotherapy

Secondary Outcomes (7)

• Left ventricular global longitudinal strain at 10-year follow-up

  10 years after completion of chemotherapy

• Left atrial volume index at 10-year follow-up

  10 years after completion of chemotherapy

• Right ventricular-pulmonary arterial coupling (TAPSE/PASP ratio) at 10-year follow-up

  10 years after completion of chemotherapy

• Plasma antioxidant capacity measured by ferric reducing ability of plasma assay

  Baseline (7 days before the first anthracycline chemotherapy cycle), day 3 after the first anthracycline chemotherapy cycle (cycle length: 21 days), and 10 years after completion of chemotherapy.

• Erythrocyte antioxidant enzyme activity

  Baseline (7 days before the first anthracycline chemotherapy cycle), day 3 after the first anthracycline chemotherapy cycle (cycle length: 21 days), and 10 years after completion of chemotherapy.

Study Arms (1)

Long-term anthracycline breast cancer cohort

Women with histologically confirmed breast cancer who received anthracycline-based chemotherapy (\>200 mg/m²) between 2010 and 2013 at Hospital Salvador, Santiago, Chile. This cohort was followed longitudinally from baseline pre-chemotherapy assessment and reassessed after 10 years. The study is observational and no therapeutic intervention was assigned as part of the protocol. Serial evaluations included echocardiographic parameters, inflammatory cytokines, oxidative stress biomarkers, and cardiac remodeling indicators.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with breast cancer treated at Hospital del Salvador, Santiago, Chile. Patients were consecutively recruited between 2010 and 2013 from a prospective cohort of individuals initiating anthracycline-based chemotherapy. A protocol amendment approved by the local ethics committee allowed long-term follow-up of the original cohort at 10 years for cardiovascular, inflammatory, and oxidative stress assessment.

You may qualify if:

• Female patients with histologically confirmed breast cancer
• Age between 18 and 75 years
• Indication for anthracycline-based chemotherapy (\>200 mg/m²)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Written informed consent signed prior to study participation
• Availability for baseline cardiovascular and biomarker assessment and long-term follow-up

You may not qualify if:

• History of heart failure or left ventricular dysfunction (LVEF \<53%)
• Known coronary artery disease or clinically significant ischemic heart disease
• History of clinically significant arrhythmias or requirement for antiarrhythmic therapy
• Dilated or hypertrophic cardiomyopathy
• Moderate to severe valvular heart disease (mitral or aortic stenosis or regurgitation)
• Congenital heart disease (including atrial or ventricular septal defects, patent ductus arteriosus, Ebstein anomaly, tetralogy of Fallot, coarctation of the aorta)
• Chronic kidney disease (creatinine \>2 mg/dL)
• Hepatic failure (bilirubin \>3 mg/dL, albumin \<3.5 g/dL, or prothrombin activity \<60% in absence of anticoagulation)

Sponsors & Collaborators

• University of Chile: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen Description: Peripheral blood samples were collected from participants at predefined time points. Plasma and red blood cell fractions were obtained and stored at -80 °C for subsequent biochemical analyses, including oxidative stress markers and inflammatory cytokines.

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of Medicine

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 2, 2026
• Study Start: February 1, 2011
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06