Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorUniversity Medical Center Groningen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Echocardiography

    Diagnostic test

    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

Treatment groups

455 Participants
are divided into 2 treatment groups
Group A: Breast cancer survivors1 intervention
Group B: Reference population1 intervention

Trial outcomes

Primary outcomes

1

Left ventricular systolic dysfunction

Prevalance of systolic cardiac dysfunction defined as a LVEF \<54%

Time frame
through study completion (from Ocotober 2022 - December 2024)

Secondary outcomes

1

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)
2

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)
3

Cardiovascular diseases

Prevalence of cardiovascular diseases obtained from electronic patient records

Time frame
through study completion (from Ocotober 2022 - December 2024)
4

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)

Other outcomes

1

Patient characteristics

age, BMI, menopausal state

Time frame
through study completion (from Ocotober 2022 - December 2024)
2

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)
3

Depression

Symptoms of depression measured with Hospital Anxiety and Depression Scale - Despression (HADS-D)

Time frame
through study completion (from Ocotober 2022 - December 2024)
4

Anxiety

Symptoms of anxiety measured with Hospital Anxiety and Depression Scale - Anxiety (HADS-A)

Time frame
through study completion (from Ocotober 2022 - December 2024)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator