Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Echocardiography.
- Who it may be relevant to
- Registry conditions: Neoplasm, Breast, Heart Failure, Cardiotoxicity, Ventricular Dysfunction. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)\< 54%). By contrast, there was no significant difference in an LVEF \< 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear. Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk. Study design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care. Study population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study. Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF \<54/50/45%.
Interventions
- Diagnostic test Echocardiography
During echocardiography, the following parameters will be assessed: * Dimensions * Left ventricle function * Right ventricle function * Valves: Aorta valve and pulmonic valve * Other findings such as: frequency, rhythm, quality
Primary outcome measures
- Left ventricular systolic dysfunction [Time frame: through study completion (from Ocotober 2022 - December 2024)]
Secondary outcome measures (4)
- Clinically used LVEF cut-off points <45% and <50% [Time frame: through study completion (from Ocotober 2022 - December 2024)]
- Course of cardiac function [Time frame: through study completion (from Ocotober 2022 - December 2024)]
- Cardiovascular diseases [Time frame: through study completion (from Ocotober 2022 - December 2024)]
- Symptoms of hearth failure [Time frame: through study completion (from Ocotober 2022 - December 2024)]
Eligibility criteria
Inclusion criteria
- Patients who previously took part in de BLOC-I study will be included. These criteria were:
- females diagnosed with stage I-III BC at least five years ago or local or locoregional recurrence of BC at least five years ago
- treatment with chemotherapy and/or radiotherapy.
Exclusion criteria
- Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.
Exclusion criteria for the BC survivors in the BLOC-I study were:
- metastatic disease at the time of BC diagnosis;
- BC treatment after 80 years of age;
- history of treatment for other types of cancer.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Publications
- Boerman LM, Maass SWMC, van der Meer P, Gietema JA, Maduro JH, Hummel YM, Berger MY, de Bock GH, Berendsen AJ. Long-term outcome of cardiac function in a population-based cohort of breast cancer survivors: A cross-sectional study. Eur J Cancer. 2017 Aug;81:56-65. doi: 10.1016/j.ejca.2017.05.013. Epub 2017 Jun 8. PMID 28601706
Identifiers
NCT: NCT05851053 · 202100903