Clinical trial · Observational
ANTthracycline-induced Inflammation and OXidative Stress: 10-year Follow-up
Long-Term Effects of Anthracycline Chemotherapy on Inflammatory Cytokines, Redox Status, and Ventricular Function in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. Do inflammatory cytokine levels change after anthracycline chemotherapy and remain altered many years after treatment? 2. Are long-term markers of oxidative stress and antioxidant capacity associated with changes in heart structure or function after anthracycline exposure? This study does not include a comparison group. All participants were previously treated with anthracycline-based chemotherapy as part of their standard cancer care. Participants will: 1. Provide blood samples for the measurement of inflammatory cytokines and oxidative stress-related biomarkers 2. Undergo a clinical cardiovascular evaluation 3. Receive a transthoracic echocardiogram to assess heart function, including measures of systolic and diastolic function and myocardial deformation 4. Participate in a long-term follow-up assessment approximately 10 years after their initial cancer treatment
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anthracycline Related Cardiotoxicity in Breast Cancer | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Long-term anthracycline breast cancer cohort
- description
- 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.
Primary outcomes (2)
- measure
- Change in left ventricular ejection fraction from baseline to 10-year follow-up
- timeFrame
- From baseline (7 days before the first anthracycline chemotherapy cycle) to 10 years after completion of chemotherapy
- description
- 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.
- measure
- Change in left ventricular filling pressure (E/e' ratio) from baseline to 10-year follow-up
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available