The 5-FU Holter Study
Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
2 other identifiers
interventional
10
1 country
1
Brief Summary
To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedDecember 9, 2024
December 1, 2024
8 months
June 4, 2024
December 4, 2024
Conditions
Outcome Measures
Primary Outcomes (10)
Recruitment rate
The percentage of participants who were contacted and joined the study will be reported.
Up to 1 year
Acceptability rate
The percentage of participants who joined the study and wore the Holter monitor for the required study duration.
Up to 1 year
Completion rate
The percentage of participants who joined the study and completed all study assessments
Up to 1 year
Overall time required to recruit to the target sample size
The overall time in weeks required to recruit participants for the feasibility study will be reported.
Up to 1 year
Clinician experience of recruitment
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)
After 1 year
Clinician experience of barriers to recruitment
Clinician Survey administered at end of study recruitment to measure clinicians' perceived barriers to recruitment (open ended questions)
After 1 year
Clinician experience of software module (Pathfinder SL) to measure ST segments using Holter monitoring while receiving infusional 5-FU chemotherapy
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)
After 1 year
FBAL (fluoro-beta-alanine) Excretion rate
Cumulative urine sample collected over 3 hours
3 hours
FBAL (fluoro-beta-alanine) Area under the Curve (AUC)
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
0, 20 minutes, 1 hour, 3 hours
FBAL (fluoro-beta-alanine) Clearance (CL)
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
0, 20 minutes, 1 hour, 3 hours
Study Arms (1)
Holter monitor
EXPERIMENTALHolter monitor for 48 hours
Interventions
Holter 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- ECG with left bundle branch block or left ventricular hypertrophy with strain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Auckland, New Zealandlead
- Gut Cancer Foundationcollaborator
- Auckland City Hospitalcollaborator
- The Heart Groupcollaborator
Study Sites (1)
Auckland City Hospital
Auckland, 1023, New Zealand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2024
First Posted
August 6, 2024
Study Start
November 1, 2024
Primary Completion
July 1, 2025
Study Completion
January 1, 2026
Last Updated
December 9, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share