Auckland City Hospital
Auckland, 1023, New Zealand
Location status: Recruiting
Recruiting
NCT Number: NCT06538610
The 5-FU Holter Study
To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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 (e.g. chest pain, myocardial infarction (heart attack) and/or 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with diagnosis of gastrointestinal malignancy
- Planned to receive either FOLFOX chemotherapy with any treatment intent
- Aged ≥ 18 years at time of signing informed consent form
Exclusion criteria
- ECG with left bundle branch block or left ventricular hypertrophy with strain
Treatment and study plan
Holter monitor
DeviceHolter monitor fitted from start of 5-FU infusion (Day 1) to 5-FU infusion ending (Day 3).
Holter monitor to be worn for approximately 46-48 hours.
Primary outcomes
-
Recruitment rate
Time frame: Up to 1 year
The percentage of participants who were contacted and joined the study will be reported.
-
Acceptability rate
Time frame: Up to 1 year
The percentage of participants who joined the study and wore the Holter monitor for the required study duration.
-
Completion rate
Time frame: Up to 1 year
The percentage of participants who joined the study and completed all study assessments
-
Overall time required to recruit to the target sample size
Time frame: Up to 1 year
The overall time in weeks required to recruit participants for the feasibility study will be reported.
-
Clinician experience of recruitment
Time frame: After 1 year
Clinician Survey administered at end of study recruitment to measure clinicians' perceived ease of recruitment (5-point Likert scale 1=Difficult to 5=Very easy)
-
Clinician experience of barriers to recruitment
Time frame: After 1 year
Clinician Survey administered at end of study recruitment to measure clinicians' perceived barriers to recruitment (open ended questions)
-
Clinician experience of software module (Pathfinder SL) to measure ST segments using Holter monitoring while receiving infusional 5-FU chemotherapy
Time frame: After 1 year
Clinician Survey administered at the end of study recruitment to measure clinicians' perceived quality of Holter monitor recordings (5-point Likert scale 1=Poor to 5=Excellent)
-
FBAL (fluoro-beta-alanine) Excretion rate
Time frame: 3 hours
Cumulative urine sample collected over 3 hours
-
FBAL (fluoro-beta-alanine) Area under the Curve (AUC)
Time frame: 0, 20 minutes, 1 hour, 3 hours
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
-
FBAL (fluoro-beta-alanine) Clearance (CL)
Time frame: 0, 20 minutes, 1 hour, 3 hours
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
Study contacts
Contact information is provided by the study sponsor or research team.
Jade Scott
CONTACT
Sarah Benge
CONTACT
Sponsors and collaborators
Lead sponsor
University of Auckland, New Zealand
Other
Collaborators
- Auckland City Hospital
- Gut Cancer Foundation
- The Heart Group
Registry information
Official study title
Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Aug 6, 2024
- Registry last updated
- Dec 9, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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