Prevention of Chest Pain in Chemo-treated Cancer Patients

Vejle Hospital218 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

218

Conditions

Solid Carcinoma 5-Fluorouracil Toxicity Cardiotoxicity Chemotherapeutic Toxicity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome

Time frame: 6 months

Secondary Outcomes

Chest pain

Incidence of chest pain