The 5-FU Holter Study
ConditionGastrointestinal Malignancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Auckland, New Zealand
About this trial
To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Holter monitor
DeviceHolter 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Holter monitorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
The percentage of participants who were contacted and joined the study will be reported.
Time frame
Up to 1 year2
Acceptability rate
The percentage of participants who joined the study and wore the Holter monitor for the required study duration.
Time frame
Up to 1 year3
Completion rate
The percentage of participants who joined the study and completed all study assessments
Time frame
Up to 1 year4
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.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Auckland, New Zealand
Lead sponsor
Auckland City Hospital
Sponsor institution
Gut Cancer Foundation
Collaborator
Auckland City Hospital
Collaborator
The Heart Group
Collaborator
Source ClinicalTrials.gov