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

NCT ID: NCT05851053

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 455 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-12-31

Brief Summary

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%.

Conditions

Neoplasm, Breast; Heart Failure; Cardiotoxicity; Ventricular Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Breast cancer survivors

Survivors of BC, diagnosed ≥11 years ago, who received chemotherapy and/or radiotherapy

Echocardiography

Intervention Type: 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

Reference population

Age and GP matched reference population without a history of cancer

Echocardiography

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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.

• metastatic disease at the time of BC diagnosis;
• BC treatment after 80 years of age;
• history of treatment for other types of cancer.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Daan Brandenbarg, PhD

Role: CONTACT

d.brandenbarg@umcg.nl

0031628475305

Laurine T van der Wal, MSc

Role: CONTACT

l.t.van.der.wal@umcg.nl

0031503616154

Facility Contacts

Laurine T van der Wal, MSc

Role: primary

l.t.van.der.wal@umcg.nl

0031503616154

References

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.

Reference Type: BACKGROUND

PMID: 28601706 (View on PubMed)

Other Identifiers

202100903

Identifier Type: -

Identifier Source: org_study_id