About this trial
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%.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.
metastatic disease at the time of BC diagnosis;
BC treatment after 80 years of age;
history of treatment for other types of cancer.
Trial population
BC survivors were matched with women of the same age (±1 year) who had the same GP, but who had no history of cancer or cancer treatment (chemotherapy or radiotherapy). A longitudinal matched cohort design consisting of two cohorts in primary care: one with survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and one with a matched reference population with no history of cancer.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Echocardiography
Diagnostic testDuring 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
Treatment groups
Trial outcomes
Primary outcomes
Left ventricular systolic dysfunction
Prevalance of systolic cardiac dysfunction defined as a LVEF \<54%
Secondary outcomes
Clinically used LVEF cut-off points <45% and <50%
Prevalance of systolic cardiac dysfunction defined as a LVEF \<45% and \<50%
Course of cardiac function
Rate of change of systolic and diastolic cardiac function by change in LVEF
Cardiovascular diseases
Prevalence of cardiovascular diseases obtained from electronic patient records
Symptoms of hearth failure
Clinical symptoms of heart failure measured using a self-constructed questionnaire
Other outcomes
Patient characteristics
age, BMI, menopausal state
Physical activity
Changes in Physical Acticity measured with Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)
Depression
Symptoms of depression measured with Hospital Anxiety and Depression Scale - Despression (HADS-D)
Anxiety
Symptoms of anxiety measured with Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
Sponsors and contacts
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University Medical Center Groningen
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator