Prevention of Chest Pain in Chemo-treated Cancer Patients

NCT03486340 | Completed

• 1 other identifier: CATCH2018
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Carcinoma; 5-Fluorouracil Toxicity; Cardiotoxicity; Chemotherapeutic Toxicity; Acute Coronary Syndrome; Coronary Artery Calcification; Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• Chest pain

  6 months

Study Arms (2)

Cardiological assessment

EXPERIMENTAL

a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment

Procedure: Cardiologic assessment

Standard treatment

NO INTERVENTION

Standard chemotherapeutic treatment

Interventions

Cardiologic assessment PROCEDURE

Aggressive ischemic risk factor management

Cardiological assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically verified cancer
• First-time treatment with 5-FU/Capecitabine
• Expected remaining lifetime \> 6 months
• Informed consent

You may not qualify if:

• Known ischemic heart disease
• Ischemia-suspicious symptoms prior to 5-FU treatment
• Ischemia-suspicious ECG-changes prior to 5-FU treatment

Sponsors & Collaborators

• Vejle Hospital: lead
• Region of Southern Denmark: collaborator

Study Sites (1)

Departments of Oncology and Medicine, Vejle Hospital

Vejle, Denmark

Location

Related Publications (1)

• Lyhne JD, Hansen VB, Vestergaard LD, Hosbond SE, Busk M, Gnanaganesh M, Maae E, Havelund BM, Hansen TF, Timm S, Jensen LH, Lyhne MD. Primary prevention of cardiotoxicity in cancer patients treated with fluoropyrimidines: a randomized controlled trial. Cardiooncology. 2025 May 17;11(1):48. doi: 10.1186/s40959-025-00344-3.

  PMID: 40382663 DERIVED

MeSH Terms

Conditions

Cardiotoxicity; Acute Coronary Syndrome; Chest Pain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Myocardial Ischemia; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Vibeke B Hansen, MD, PhD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

• Lars H Jensen, MD, PhD

  Department of Oncology, Vejle Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 3, 2018
• Study Start: April 11, 2018
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)