Assessing heart function in recently-diagnosed breast cancer patients
Research type
Research Study
Full title
Longitudinal Characterisation of Cardiac Function in recently-diagnosed breast cancer patients
IRAS ID
188676
Contact name
Erifyli Piastopoulou
Contact email
Clinicaltrials.gov Identifier
TBC, TBC
Duration of Study in the UK
1 years, 6 months, days
Research summary
We will investigate the influence of systemic adjuvant therapy (SAT: chemotherapy +/- trastuzumab) on heart function/rhythm and cardio-respiratory fitness (CRF) in recently diagnosed breast cancer patients. In some patients, SAT damages the heart (so-called ‘cardiotoxicity’) and this can have a serious impact on quality of life and survival. The conventional methods for assessing heart function (specifically the ‘ejection fraction’) are nuclear medicine (MUGA) and echocardiography. These are performed before and after chemotherapy in patients at higher risk of cardiotoxicity (those who need anthracyclines and have risk factors for cardiotoxicity) and in all patients receiving trastuzumab (who receive further assessments at 3-4 month intervals until completion of treatment). It is not practical or cost-effective to scan more frequently using MUGA (the method used in ABMU) but we will investigate whether an alternative method (Impedance Cardiography, ICG) could be used instead. This technique would allow more frequent monitoring throughout treatment because it is inexpensive, does not involve ionising radiation and is easy to perform.
Anticancer therapies can also lead to heart rhythm abnormalities and cardiac autonomic dysfunction, but these are not routinely monitored in breast cancer patients. We will quantify the impact of SAT on these temporal ECG variables. We will also characterise (for the first time) changes in body composition, CRF and physical activity that occur during and following SAT, and we will investigate cause-effect relationships between these using cardiopulmonary exercise testing (fitness), accelerometry (activity levels) and DEXA radiography (body composition). The monitoring techniques used in routine care cannot detect the variety of cardiorespiratory changes that might occur, and our study will lead to better diagnosis of cardiorespiratory status in the future. Eligible participants: women aged >18 years with early invasive breast cancer (stage I-III), treated surgically, due to start SAT (chemotherapy +/- trastuzumab) and WHO performance status 0-2.
REC name
Wales REC 6
REC reference
16/WA/0128
Date of REC Opinion
21 Apr 2016
REC opinion
Unfavourable Opinion