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OpenTrials
Completed

NCT Number: NCT03486340

Prevention of Chest Pain in Chemo-treated Cancer Patients

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.

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Key information

Conditions

Solid Carcinoma 5-Fluorouracil Toxicity Acute Coronary Syndrome Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Chemotherapeutic Toxicity Chest Pain Coronary Artery Calcification Drug-Related Side Effects and Adverse Reactions Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Signs and Symptoms Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departments of Oncology and Medicine, Vejle Hospital

Vejle, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiologic assessment

Procedure

Aggressive ischemic risk factor management

Primary outcomes

  1. 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

  1. Chest pain

    Time frame: 6 months

    Incidence of chest pain

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Region of Southern Denmark

Registry information

Official study title

Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil

Acronym: CATCH

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2018
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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