Monitoring heart health in patients receiving 5-FU chemotherapy
Official title: Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
Run by University of Auckland, New Zealand · NCT06538610 · Data updated 2026-11-12
This study is testing if using a heart monitor at home can help keep track of heart health in patients getting 5-FU chemotherapy for cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University of Auckland, New Zealand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Auckland) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | July 2025 |
| Study ends | January 2026 |
| Registry record updated | December 9, 2024 |
| Trial ID | NCT06538610 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a diagnosis of gastrointestinal malignancy who are planned to receive FOLFOX chemotherapy.
✕Probably not a fit
Patients with pre-existing ECG abnormalities such as left bundle branch block or left ventricular hypertrophy with strain may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the feasibility of using ambulatory ECG monitoring, specifically a Holter monitor, for patients undergoing treatment with 5-fluorouracil (5-FU) chemotherapy for gastrointestinal malignancies. Given the risk of cardiotoxicity associated with 5-FU, which can lead to serious cardiac events, the study aims to monitor patients in real-life conditions while they receive infusional chemotherapy at home. The goal is to gather preliminary data that could inform future studies on the relationship between 5-FU metabolism and cardiac health. By identifying asymptomatic cardiotoxicity early, the study hopes to improve patient safety and treatment outcomes.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring of heart health in patients receiving 5-FU, potentially preventing serious cardiac events and improving treatment outcomes.
How similar studies have gone: While the approach of using Holter monitoring in this context is novel, similar studies have indicated the importance of monitoring cardiac health in patients undergoing chemotherapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Auckland City Hospital
Auckland, New Zealand Recruiting
Study contacts
- Study coordinator: Jade Scott
- Email: j.scott@auckland.ac.nz
- Phone: +64 (0)9 923 4222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.