Monitoring heart health in patients receiving 5-FU chemotherapy
Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Auckland, New Zealand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Auckland) |
| Trial ID | NCT06538610 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of gastrointestinal malignancy who are planned to receive FOLFOX chemotherapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Auckland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.