Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486340
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Region of Southern Denmark
Information provided by (Responsible Party):
Vejle Hospital

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
Solid Carcinoma 5-Fluorouracil Toxicity Cardiotoxicity Chemotherapeutic Toxicity Acute Coronary Syndrome Coronary Artery Calcification Chest Pain Procedure: Cardiologic assessment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 11, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Chest pain [ Time Frame: 6 months ]
    Incidence of chest pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486340


Contacts
Layout table for location contacts
Contact: Mads D Lyhne, MD +45 20450486 Mads.Dam.Lyhne@rsyd.dk
Contact: Vibeke B Hansen, MD, PhD vibeke.brogaard.hansen@rsyd.dk

Locations
Layout table for location information
Denmark
Departments of Oncology and Medicine, Vejle Hospital Recruiting
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
Region of Southern Denmark
Investigators
Layout table for investigator information
Principal Investigator: Vibeke B Hansen, MD, PhD Vejle Hospital
Study Chair: Lars H Jensen, MD, PhD Department of Oncology, Vejle Hospital, Denmark

Layout table for additonal information
Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT03486340     History of Changes
Other Study ID Numbers: CATCH2018
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chest Pain
Pain
Acute Coronary Syndrome
Cardiotoxicity
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries