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

Heart Failure Clinical Trial

— BLOC-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851053
• Other study ID #: 202100903
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: Daan Brandenbarg, PhD
• Phone: 0031628475305
• Email: d.brandenbarg[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 455
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cardiotoxicity
• Heart Failure
• Neoplasm, Breast
• Ventricular Dysfunction

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics	age, BMI, menopausal state	through study completion (from Ocotober 2022 - December 2024)
Other	Physical activity	Changes in Physical Acticity measured with Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)	through study completion (from Ocotober 2022 - December 2024)
Other	Depression	Symptoms of depression measured with Hospital Anxiety and Depression Scale - Despression (HADS-D)	through study completion (from Ocotober 2022 - December 2024)
Other	Anxiety	Symptoms of anxiety measured with Hospital Anxiety and Depression Scale - Anxiety (HADS-A)	through study completion (from Ocotober 2022 - December 2024)
Other	Fatigue	Multidimensional assessment of fatigue mesaured with Multidimensional Fatigue Index - 20 (MFI-20).	through study completion (from Ocotober 2022 - December 2024)
Other	Use of cardiovascular medication	Use of cardiovascular medication based on electronic patient records	through study completion (from Ocotober 2022 - December 2024)
Other	Smoking behavior (self-reported pack years)	Smoking behavior	through study completion (from Ocotober 2022 - December 2024)
Primary	Left ventricular systolic dysfunction	Prevalance of systolic cardiac dysfunction defined as a LVEF <54%	through study completion (from Ocotober 2022 - December 2024)
Secondary	Clinically used LVEF cut-off points <45% and <50%	Prevalance of systolic cardiac dysfunction defined as a LVEF <45% and <50%	through study completion (from Ocotober 2022 - December 2024)
Secondary	Course of cardiac function	Rate of change of systolic and diastolic cardiac function by change in LVEF	through study completion (from Ocotober 2022 - December 2024)
Secondary	Cardiovascular diseases	Prevalence of cardiovascular diseases obtained from electronic patient records	through study completion (from Ocotober 2022 - December 2024)
Secondary	Symptoms of hearth failure	Clinical symptoms of heart failure measured using a self-constructed questionnaire	through study completion (from Ocotober 2022 - December 2024)