Prevention of Chest Pain in Chemo-treated Cancer Patients

NCT03486340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2024-07-08

No results posted yet for this study

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

Interventions

PROCEDURE

Cardiologic assessment

Aggressive ischemic risk factor management

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER
  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Vibeke B Hansen, MD, PhD · Vejle Hospital

  • Lars H Jensen, MD, PhD · Department of Oncology, Vejle Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2024-06-07
Completion
2024-06-07

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03486340 on ClinicalTrials.gov