An observational study in Neoplasm, Breast, Heart Failure and Cardiotoxicity, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University Medical Center Groningen · Observational
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%.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 455 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusion criteria for the BC survivors in the BLOC-I study were:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Survivors of BC, diagnosed ≥11 years ago, who received chemotherapy and/or radiotherapy
Diagnostic Test: Echocardiography
Age and GP matched reference population without a history of cancer
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
Left ventricular systolic dysfunction
Prevalance of systolic cardiac dysfunction defined as a LVEF \<54%
Time frame: through study completion (from Ocotober 2022 - December 2024)
Clinically used LVEF cut-off points <45% and <50%
Prevalance of systolic cardiac dysfunction defined as a LVEF \<45% and \<50%
Time frame: through study completion (from Ocotober 2022 - December 2024)
Course of cardiac function
Rate of change of systolic and diastolic cardiac function by change in LVEF
Time frame: through study completion (from Ocotober 2022 - December 2024)
Cardiovascular diseases
Prevalence of cardiovascular diseases obtained from electronic patient records
Time frame: through study completion (from Ocotober 2022 - December 2024)
Symptoms of hearth failure
Clinical symptoms of heart failure measured using a self-constructed questionnaire
Time frame: through study completion (from Ocotober 2022 - December 2024)
Patient characteristics
age, BMI, menopausal state
Time frame: through study completion (from Ocotober 2022 - December 2024)
Physical activity
Changes in Physical Acticity measured with Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)
Time frame: through study completion (from Ocotober 2022 - December 2024)
Depression
Symptoms of depression measured with Hospital Anxiety and Depression Scale - Despression (HADS-D)
Time frame: through study completion (from Ocotober 2022 - December 2024)
Anxiety
Symptoms of anxiety measured with Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
Time frame: through study completion (from Ocotober 2022 - December 2024)
Fatigue
Multidimensional assessment of fatigue mesaured with Multidimensional Fatigue Index - 20 (MFI-20).
Time frame: through study completion (from Ocotober 2022 - December 2024)
Use of cardiovascular medication
Use of cardiovascular medication based on electronic patient records
Time frame: through study completion (from Ocotober 2022 - December 2024)
Smoking behavior (self-reported pack years)
Smoking behavior
Time frame: through study completion (from Ocotober 2022 - December 2024)
Plan to share: Undecided
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