Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03266809
Status:
COMPLETED
Last Update Posted:
2022-12-01
First Post:
2017-08-25
Brief Title:
CARdiac Function Evaluation in Breast Cancer Patients
Sponsor:
Swansea University
Organization:
Swansea University
Study Overview
Official Title:
Longitudinal Characterisation of Cardiac Function in Recently-diagnosed Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE-B
Brief Summary:
This study will investigate the influence of systemic adjuvantneoadjuvant therapy SAT chemotherapy - anti-HER2 antibodies trastuzumab - pertuzumab on heart functionrhythm 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 patients 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 eg 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
Detailed Description:
This study will focus on the following
1 Cardiac function assessment The conventional method for assessing heart function in terms of ejection fraction in patients being treated for cancer uses nuclear medicine MUGA scan MRI can also provide this information but it is not typically used for cardiac function assessment in these patients MUGA scans are typically performed before chemotherapy in selected patients at higher risk of cardiotoxicity and in all cases before starting anti-HER2 antibody treatment trastuzumab pertuzumab Patients receiving anti-HER2 antibody treatment receive repeat cardiac assessments at 3-4 month intervals until the completion of treatment - it is not practical or cost-effective to scan more frequently This study will determine whether an alternative and inexpensive method for monitoring heart function Impedance Cardiography ICG can adequately quantify changes in ejection fraction during treatment If it can then this technique could be used more frequently during and following treatment with the aim of determining the treatment stages during which the heart is most at risk of damage The ability of ICG to dynamically characterise a relatively rapid decline in cardiac function in breast cancer patients has not been established Neither has its performance been compared with MRI or MUGA in this population This study will investigate whether ICG is a sufficiently accurate and reliable alternative to MRIMUGA for determining cardiac dysfunction during and following cancer treatment
2 Cardiac rhythm and autonomic function assessment Heart rate variability HRV reflects the modulation of the heart by the autonomic nervous system and it can be quantified using several different methods based on analysis of the temporal changes between successive heartbeats The development of autonomic dysfunction in breast cancer patients has been shown in a few small clinical studies but the majority of these studies have considered HR rather than HRV which is a much less robust measure of autonomic function The few studies that have used HRV analysis have demonstrated significant reductions in HRV following the completion of anthracycline-based therapy Previous research on other ECG markers eg QT and QRS duration in breast cancer patients has mainly focused on anthracycline-based regimes the influence of trastuzumab treatment on ECG makers has been evaluated in only two studies to date It is still not clear whether these changes can predict subsequent LV dysfunction although QT variability is a possible marker of myocardial contractility and has been shown to increase as a result of anthracycline therapy in breast cancer patients This study aims to characterise the impact of different treatment regimes on the temporal properties of the ECG and will compare beat-to-beat QT variability and beat-to-beat T wave variability in breast cancer patients receiving a range of treatment regimes
3 Body composition and cardiorespiratory fitness assessment This study also aims to characterise the patterns of change in body composition physical activity and cardiorespiratory fitness in breast cancer patients The study will examine whether these modifiable factors might influence a patients susceptibility to cardiac changes during treatment and in turn how these factors are affected by treatment Of particular interest it has been suggested that cardiorespiratory fitness measured by the rate of oxygen uptake is impaired in breast cancer patients compared to healthy controls even seven years following the completion of treatment Oxygen-uptake analysis will be performed in this study to explore possible compensatory mechanisms for abnormal pathology- or treatment-induced cardiac function in breast cancer patients Fitness physical activity and body composition will be assessed quantitatively using a range of objective techniques including cardiopulmonary exercise testing on a cycle ergometer fitness with breath-by-breath gas analysis cardiorespiratory function accelerometery activity levels and DEXA radiography scans body composition
The main research questions in this study are
1 Is the CARE-B protocol practically feasible and tolerable to early-stage breast cancer patients
2 What is the level of agreement between cardiac ventricular function determined using cardiac MRI MUGA and Impedance Cardiography in breast cancer patients receiving SAT
3 Is cardiac rhythm heart rate and QT variability altered in breast cancer patients receiving SAT
4 Is oxygen transport and oxygen uptake into tissue altered in breast cancer patients receiving SAT
5 Does a patients baseline physical activity fitness and body composition affect their susceptibilities to treatment-induced cardio-respiratory problems
6 Does a patients physical activity physical fitness and body composition change appreciably during SAT in these patients
1 Cardiac function assessment The conventional method for assessing heart function in terms of ejection fraction in patients being treated for cancer uses nuclear medicine MUGA scan MRI can also provide this information but it is not typically used for cardiac function assessment in these patients MUGA scans are typically performed before chemotherapy in selected patients at higher risk of cardiotoxicity and in all cases before starting anti-HER2 antibody treatment trastuzumab pertuzumab Patients receiving anti-HER2 antibody treatment receive repeat cardiac assessments at 3-4 month intervals until the completion of treatment - it is not practical or cost-effective to scan more frequently This study will determine whether an alternative and inexpensive method for monitoring heart function Impedance Cardiography ICG can adequately quantify changes in ejection fraction during treatment If it can then this technique could be used more frequently during and following treatment with the aim of determining the treatment stages during which the heart is most at risk of damage The ability of ICG to dynamically characterise a relatively rapid decline in cardiac function in breast cancer patients has not been established Neither has its performance been compared with MRI or MUGA in this population This study will investigate whether ICG is a sufficiently accurate and reliable alternative to MRIMUGA for determining cardiac dysfunction during and following cancer treatment
2 Cardiac rhythm and autonomic function assessment Heart rate variability HRV reflects the modulation of the heart by the autonomic nervous system and it can be quantified using several different methods based on analysis of the temporal changes between successive heartbeats The development of autonomic dysfunction in breast cancer patients has been shown in a few small clinical studies but the majority of these studies have considered HR rather than HRV which is a much less robust measure of autonomic function The few studies that have used HRV analysis have demonstrated significant reductions in HRV following the completion of anthracycline-based therapy Previous research on other ECG markers eg QT and QRS duration in breast cancer patients has mainly focused on anthracycline-based regimes the influence of trastuzumab treatment on ECG makers has been evaluated in only two studies to date It is still not clear whether these changes can predict subsequent LV dysfunction although QT variability is a possible marker of myocardial contractility and has been shown to increase as a result of anthracycline therapy in breast cancer patients This study aims to characterise the impact of different treatment regimes on the temporal properties of the ECG and will compare beat-to-beat QT variability and beat-to-beat T wave variability in breast cancer patients receiving a range of treatment regimes
3 Body composition and cardiorespiratory fitness assessment This study also aims to characterise the patterns of change in body composition physical activity and cardiorespiratory fitness in breast cancer patients The study will examine whether these modifiable factors might influence a patients susceptibility to cardiac changes during treatment and in turn how these factors are affected by treatment Of particular interest it has been suggested that cardiorespiratory fitness measured by the rate of oxygen uptake is impaired in breast cancer patients compared to healthy controls even seven years following the completion of treatment Oxygen-uptake analysis will be performed in this study to explore possible compensatory mechanisms for abnormal pathology- or treatment-induced cardiac function in breast cancer patients Fitness physical activity and body composition will be assessed quantitatively using a range of objective techniques including cardiopulmonary exercise testing on a cycle ergometer fitness with breath-by-breath gas analysis cardiorespiratory function accelerometery activity levels and DEXA radiography scans body composition
The main research questions in this study are
1 Is the CARE-B protocol practically feasible and tolerable to early-stage breast cancer patients
2 What is the level of agreement between cardiac ventricular function determined using cardiac MRI MUGA and Impedance Cardiography in breast cancer patients receiving SAT
3 Is cardiac rhythm heart rate and QT variability altered in breast cancer patients receiving SAT
4 Is oxygen transport and oxygen uptake into tissue altered in breast cancer patients receiving SAT
5 Does a patients baseline physical activity fitness and body composition affect their susceptibilities to treatment-induced cardio-respiratory problems
6 Does a patients physical activity physical fitness and body composition change appreciably during SAT in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None