ANTthracycline-induced Inflammation and OXidative Stress: 10-year Follow-up
17 participantsStarted 2011-02-01
Plain-language 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. 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
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Change in left ventricular filling pressure (E/e' ratio) 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