Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Solid Carcinoma
- Sponsor
- Vejle Hospital
- Enrollment
- 218
- Locations
- 1
- Primary Endpoint
- Acute coronary syndrome
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Acute coronary syndrome
Time Frame: 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 Outcomes
- Chest pain(6 months)