Feasibility Study of Ambulatory Holter Monitoring While Receiving Infusional Fluorouracil (5-FU) Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •ECG with left bundle branch block or left ventricular hypertrophy with strain
结局指标
主要结局
Recruitment rate
时间窗: Up to 1 year
The percentage of participants who were contacted and joined the study will be reported.
Clinician experience of recruitment
时间窗: 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 software module (Pathfinder SL) to measure ST segments using Holter monitoring while receiving infusional 5-FU chemotherapy
时间窗: 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)
Completion rate
时间窗: Up to 1 year
The percentage of participants who joined the study and completed all study assessments
Acceptability rate
时间窗: Up to 1 year
The percentage of participants who joined the study and wore the Holter monitor for the required study duration.
Clinician experience of barriers to recruitment
时间窗: After 1 year
Clinician Survey administered at end of study recruitment to measure clinicians' perceived barriers to recruitment (open ended questions)
Overall time required to recruit to the target sample size
时间窗: Up to 1 year
The overall time in weeks required to recruit participants for the feasibility study will be reported.
FBAL (fluoro-beta-alanine) Excretion rate
时间窗: 3 hours
Cumulative urine sample collected over 3 hours
FBAL (fluoro-beta-alanine) Area under the Curve (AUC)
时间窗: 0, 20 minutes, 1 hour, 3 hours
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
FBAL (fluoro-beta-alanine) Clearance (CL)
时间窗: 0, 20 minutes, 1 hour, 3 hours
Blood samples collected prechemo and 20 mins, 1 hour, 3 hours
次要结局
未报告次要终点
研究者
Jane So
Principal Investigator
Auckland City Hospital