5-Fluorouracil Toxicity, Acute Coronary Syndrome, Cardiotoxicity, Chemotherapeutic Toxicity, Chest Pain, Coronary Artery Calcification, Solid Carcinoma
Conditions
Brief summary
This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.
Interventions
PROCEDURECardiologic assessment
Aggressive ischemic risk factor management
Sponsors
Region of Southern Denmark
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically verified cancer * First-time treatment with 5-FU/Capecitabine * Expected remaining lifetime \> 6 months * Informed consent
Exclusion criteria
* Known ischemic heart disease * Ischemia-suspicious symptoms prior to 5-FU treatment * Ischemia-suspicious ECG-changes prior to 5-FU treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute coronary syndrome | 6 months | Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest pain | 6 months | Incidence of chest pain |
Countries
Denmark
Outcome results
None listed