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Prevention of Chest Pain in Chemo-treated Cancer Patients (CATCH)

V

Vejle Hospital

Status

Completed

Conditions

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

Treatments

Procedure: Cardiologic assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT03486340
CATCH2018

Details and patient eligibility

About

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.

Enrollment

218 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

218 participants in 2 patient groups

Cardiological assessment
Experimental group
Description:
a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment
Treatment:
Procedure: Cardiologic assessment
Standard treatment
No Intervention group
Description:
Standard chemotherapeutic treatment

Trial contacts and locations

1

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Central trial contact

Vibeke B Hansen, MD, PhD; Mads D Lyhne, MD, PhD

Data sourced from clinicaltrials.gov

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