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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06538610




Registration number
NCT06538610
Ethics application status
Date submitted
4/06/2024
Date registered
6/08/2024

Titles & IDs
Public title
The 5-FU Holter Study
Scientific title
Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
Secondary ID [1] 0 0
U1111-1308-6717
Secondary ID [2] 0 0
CTNZ-2022-08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Malignancy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Holter monitor

Experimental: Holter monitor - Holter monitor for 48 hours


Treatment: Devices: Holter monitor
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recruitment rate
Timepoint [1] 0 0
Up to 1 year
Primary outcome [2] 0 0
Acceptability rate
Timepoint [2] 0 0
Up to 1 year
Primary outcome [3] 0 0
Completion rate
Timepoint [3] 0 0
Up to 1 year
Primary outcome [4] 0 0
Overall time required to recruit to the target sample size
Timepoint [4] 0 0
Up to 1 year
Primary outcome [5] 0 0
Clinician experience of recruitment
Timepoint [5] 0 0
After 1 year
Primary outcome [6] 0 0
Clinician experience of barriers to recruitment
Timepoint [6] 0 0
After 1 year
Primary outcome [7] 0 0
Clinician experience of software module (Pathfinder SL) to measure ST segments using Holter monitoring while receiving infusional 5-FU chemotherapy
Timepoint [7] 0 0
After 1 year
Primary outcome [8] 0 0
FBAL (fluoro-beta-alanine) Excretion rate
Timepoint [8] 0 0
3 hours
Primary outcome [9] 0 0
FBAL (fluoro-beta-alanine) Area under the Curve (AUC)
Timepoint [9] 0 0
0, 20 minutes, 1 hour, 3 hours
Primary outcome [10] 0 0
FBAL (fluoro-beta-alanine) Clearance (CL)
Timepoint [10] 0 0
0, 20 minutes, 1 hour, 3 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• ECG with left bundle branch block or left ventricular hypertrophy with strain

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gut Cancer Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Auckland City Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Heart Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jade Scott
Address 0 0
Country 0 0
Phone 0 0
+64 (0)9 923 4222
Fax 0 0
Email 0 0
j.scott@auckland.ac.nz
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06538610