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CATCH: Prevention of Chest Pain in Chemo-treated Cancer Patients

Sponsor
Vejle Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03486340
Collaborator
Region of Southern Denmark (Other)
200
Enrollment
1
Location
2
Arms
74.6
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cardiologic assessment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil
Actual Study Start Date :
Apr 11, 2018
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cardiological assessment

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

Procedure: Cardiologic assessment
Aggressive ischemic risk factor management
No Intervention: Standard treatment

Standard chemotherapeutic treatment

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Chest pain [6 months]

    Incidence of chest pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departments of Oncology and Medicine, Vejle Hospital Vejle Denmark

Sponsors and Collaborators

  • Vejle Hospital
  • Region of Southern Denmark

Investigators

  • Principal Investigator: Vibeke B Hansen, MD, PhD, Vejle Hospital
  • Study Chair: Lars H Jensen, MD, PhD, Department of Oncology, Vejle Hospital, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT03486340
Other Study ID Numbers:
  • CATCH2018
First Posted:
Apr 3, 2018
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acute Coronary Syndrome
Cardiotoxicity
Chest Pain

Study Results

No Results Posted as of Aug 9, 2022