Gastrointestinal MalignancyNCT06538610
The 5-FU Holter Study
A study testing Holter monitor in people with Gastrointestinal Malignancy, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Malignancy
- What is being tested?
- Holter monitor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Nov 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ECG with left bundle branch block or left ventricular hypertrophy with strain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
Study Coordinator, 643074949, researchassistant@adhb.govt.nz
Jane So
About this study
Official title: Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy
Read the 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 (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.
- Conditions
- Gastrointestinal Malignancy
- Being tested
- Holter monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Holter monitor | Experimental | Holter monitor for 48 hours Receives: Device: Holter monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The percentage of participants who were contacted and joined the study will be reported.
Measured: Up to 1 year
Acceptability rate
The percentage of participants who joined the study and wore the Holter monitor for the required study duration.
Measured: Up to 1 year
Completion rate
The percentage of participants who joined the study and completed all study assessments
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: After 1 year
FBAL (fluoro-beta-alanine) Excretion rate
Cumulative urine sample collected over 3 hours
Measured: 3 hours
FBAL (fluoro-beta-alanine) Area under the Curve (AUC)
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
Measured: 0, 20 minutes, 1 hour, 3 hours
FBAL (fluoro-beta-alanine) Clearance (CL)
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
Measured: 0, 20 minutes, 1 hour, 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Nov 2024
- Primary completionJul 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Gut Cancer Foundation, Auckland City Hospital, The Heart Group
- Responsible party
- Principal investigator, Jane So, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538610
- Sponsor's protocol ID
- CTNZ-2022-08
- Other IDs
- U1111-1308-6717
- Status last verified
- Dec 2024
- First submitted
- 4 Jun 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
- ClinicalTrials.gov ID
- NCT06538610
- Acronym / sponsor ID
- CTNZ-2022-08
- Conditions
- Gastrointestinal Malignancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Gut Cancer Foundation, Auckland City Hospital, The Heart Group
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Holter monitor | Experimental | Device: Holter monitorHolter monitor for 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- ECG with left bundle branch block or left ventricular hypertrophy with strain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter monitorHolter 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. | Device | Holter monitor |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter monitor in people with Gastrointestinal Malignancy, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jade Scott (+64 (0)9 923 4222, j.scott@auckland.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Up to 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.