Prevention of Chest Pain in Chemo-treated Cancer Patients

Not Applicable

Completed

• Conditions: Cardiotoxicity; Coronary Artery Calcification; Solid Carcinoma; 5-Fluorouracil Toxicity; Chemotherapeutic Toxicity; Acute Coronary Syndrome; Chest Pain
• Interventions: Procedure: Cardiologic assessment

• Registration Number: NCT03486340
• Lead Sponsor: Vejle Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-03
• Study Start: 2018-04-11
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiological assessment	Cardiologic assessment	a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Chest pain	6 months	Incidence of chest pain

Trial Locations

Locations (1)

Departments of Oncology and Medicine, Vejle Hospital; 🇩🇰 Vejle, Denmark