CARdiac Function Evaluation in Breast Cancer Patients

NCT03266809 | Completed DMC

• 1 other identifier: 188676
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the influence of systemic adjuvant/neoadjuvant therapy (SAT: chemotherapy +/- anti-HER2 antibodies (trastuzumab +/- pertuzumab) on heart function/rhythm and cardio-respiratory fitness in recently diagnosed breast cancer patients. In some patients, SAT damages the heart (so-called 'cardiotoxicity') and this can have a serious impact on the patient's quality of life and overall survival. It has also been suggested that anticancer therapies may lead to repolarization abnormalities, QT prolongation and autonomic dysfunction, clinically reflected by an increase in HR and a reduction in heart rate variability (HRV). There is a lack of information in the literature regarding the extent and time-course of changes in cardiac function, cardiac rhythm and cardio-respiratory performance ('fitness') in these patients. Moreover, the differential influences of specific treatment regimes (e.g. SAT or SAT plus radiotherapy) and different chemotherapy drugs on cardio-respiratory performance remain unclear. A better understanding of these issues is the primary aim of this study.

Conditions

Breast Cancer Female

Keywords

Cardiac function; Cardio-toxicity

Outcome Measures

Primary Outcomes (2)

• Cardiac Function (stroke volume or ejection fraction)

  Cardiac function during/following treatment in breast cancer patients.

  At completion of treatment, an average of 13 months

• Cardiac Rhythm (heart rate variability)

  Cardiac rhythm during/following treatment in breast cancer patients.

  At completion of treatment, an average of 13 months

Secondary Outcomes (3)

• Physical activity level (accelerometer-based activity level 'counts')

  At completion of treatment, an average of 13 months

• Cardiorespiratory function (rate of respiratory oxygen uptake)

  At completion of treatment, an average of 13 months

• Body mass composition (from DEXA scan)

  At completion of treatment, an average of 13 months

Study Arms (1)

Breast Cancer Patients

Eligible participants will be women aged 18 years or over who have the following main characteristics: * Early invasive breast cancer (stage I-III) * Due to start SAT (adjuvant or neoadjuvant chemotherapy +/- trastuzumab +/- pertuzumab) * WHO performance status 0-2.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years or older who have early invasive breast cancer and who are due to begin adjuvant or neoadjuvant therapy for this condition, but who are otherwise free of major cardiovascular or chronic respiratory disease and who are capable of undertaking physical exercise.

You may qualify if:

• Eligible participants will be women aged 18 years or over with the following characteristics:
• Early invasive breast cancer (stage I-III)
• Due to start adjuvant or neoadjuvant therapy including either anthracycline-based chemotherapy, or chemotherapy + trastuzumab +/- pertuzumab
• WHO performance status \<=2
• Absence of major cardiovascular or chronic respiratory problems, or other conditions that in the opinion of the clinician would contraindicate the use of physical exercise assessments
• Absence of contraindications for MRI scans, as listed in Paragraph 3.3. Patients unsuitable or unwilling to undergo MRI scans will be eligible for the study only if they are planned to receive trastuzumab, since this will include LVEF monitoring with MUGA scans or echocardiograms as part of routine care
• Provision of signed informed consent.

You may not qualify if:

• Presence of major cardiovascular or chronic respiratory problems, or other conditions that in the opinion of the clinician would contraindicate the use of treadmill exercise assessments
• Presence of contraindications for MRI scans:
• Internal electronic devices such as neurostimulators or defibrillators
• Replacement heart valve
• Cardiac pacemaker
• Intracranial vessel clips
• Internal ear implant
• Claustrophobia
• Pregnancy.

Sponsors & Collaborators

• Swansea University: lead
• Abertawe Bro Morgannwg University Health Board: collaborator

Study Sites (1)

Singleton Hospital

Swansea, Wales, SA2 8PP, United Kingdom

Location

Study Officials

• Professor Lewis

  Swansea University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: August 1, 2017
• Primary Completion: September 28, 2019
• Study Completion: April 1, 2020
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)