Ambulatory Holter Monitoring Feasibility Study
Feasibility study of ambulatory Holter monitoring while receiving infusional 5-FU chemotherapy
TYPE: New Zealand Research Study
STATUS: Currently recruiting
GCF CONTRIBUTION: $149,000
GCF donors are funding this feasibility study which will recruit 10 patients in Auckland.
5-Fluorouracil (5-FU) is the main chemotherapy drug used for the treatment of several gut cancers. Side effects can lead to early stopping of treatment, even when it is working well to control the cancer. One of the most serious side effects of 5-FU is when it causes heart problems. Heart attacks causing death are fortunately rare, but rates of silent heart attacks are higher. Electrical monitoring of the heart (ECG) is one of the best ways to discover such heart problems.
The development of cardiotoxicity requires permanent discontinuation of 5-FU chemotherapy. There are no PHARMAC funded alternatives for patients who discontinue 5-FU due to cardiotoxicity. Discontinuation of 5-FU is likely to lead to a worse outcomes for these patients.
A recent study of 108 patients using ambulatory Holter monitoring detected results that represent a significant risk for cancer patients receiving 5-FU chemotherapy in Aotearoa New Zealand and worldwide. Understanding which patients may be at increased risk of cardiotoxicity may allow us to identify these individuals early and develop mitigation strategies.
This study aims to determine:
whether the use of continuous ECG monitoring (ambulatory Holter monitoring) in real-life conditions (over two days, while at home receiving infusional 5-FU chemotherapy), can appropriately assess these types of silent heart attacks (ST changes) and
determine the acceptability of this study to both patients and clinicians.
This will provide information for the development of a future larger study that aims to assess if silent heart attacks while receiving 5-FU chemotherapy relate to chemotherapy breakdown products (fluoro-beta-alanine, FBAL) and kidney function, and may allow early identification and management to occur to minimise risk.
FEBRUARY 2025 Update
The first participant has now been registered for the 5FU Holter Study.