Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538610
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-04
Brief Title:
The 5-FU Holter Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil 5-FU Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the feasibility of using ambulatory ECG monitoring Holter monitor for patients receiving 5-FU chemotherapy
Detailed Description:
5-fluorouracil 5-FU is the key chemotherapy component in systemic treatment of colorectal cancer However 5-FU treatment is also associated with cardiotoxicity which can have devastating consequences
Cardiotoxicity can be both symptomatic eg chest pain myocardial infarction heart attack andor sudden death as well as asymptomatic silent myocardial ischemia which is only detectable by ECG Data suggests that asymptomatic cardiotoxicity may be relatively common 30 of patients
About 69 of the cardiac events are seen during or within the first 72 hours of the first cycle of 5-FU
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 oncological outcome survival time for the patient
One proposed mechanism for 5-FU cardiotoxicity involves fluoro-beta-alanine FBAL which is a metabolite formed when 5-FU is catalysed by the enzyme dihydropyrimidine dehydrogenase DPD The rationale for this feasibility study is to provide preliminary information required to develop a prospective pharmacokinetic study exploring plasma clearance of FBAL and 5-FU cardiotoxicity
This study aims to determine i 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 is able to appropriately assess these types of silent heart attacks ST changes and ii the acceptability of this study to both patients and clinicians iii the excretion rate of FBAL over the 48 hour time period interpatient pharmacokinetic variability in FBAL excretion
Cardiotoxicity can be both symptomatic eg chest pain myocardial infarction heart attack andor sudden death as well as asymptomatic silent myocardial ischemia which is only detectable by ECG Data suggests that asymptomatic cardiotoxicity may be relatively common 30 of patients
About 69 of the cardiac events are seen during or within the first 72 hours of the first cycle of 5-FU
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 oncological outcome survival time for the patient
One proposed mechanism for 5-FU cardiotoxicity involves fluoro-beta-alanine FBAL which is a metabolite formed when 5-FU is catalysed by the enzyme dihydropyrimidine dehydrogenase DPD The rationale for this feasibility study is to provide preliminary information required to develop a prospective pharmacokinetic study exploring plasma clearance of FBAL and 5-FU cardiotoxicity
This study aims to determine i 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 is able to appropriately assess these types of silent heart attacks ST changes and ii the acceptability of this study to both patients and clinicians iii the excretion rate of FBAL over the 48 hour time period interpatient pharmacokinetic variability in FBAL excretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None