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

Primary Purpose

Solid Carcinoma, 5-Fluorouracil Toxicity, Cardiotoxicity

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Cardiologic assessment

About this trial

This is an interventional prevention trial for Solid Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Departments of Oncology and Medicine, Vejle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardiological assessment

Standard treatment

Arm Description

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

Standard chemotherapeutic treatment

Outcomes

Primary Outcome Measures

Acute coronary syndrome

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

Chest pain

Incidence of chest pain

Full Information

NCT ID

NCT03486340

First Posted

March 26, 2018

Last Updated

September 1, 2023

Sponsor

Vejle Hospital

Collaborators

Region of Southern Denmark

1. Study Identification

Unique Protocol Identification Number

NCT03486340

Brief Title

Prevention of Chest Pain in Chemo-treated Cancer Patients

Acronym

CATCH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 11, 2018 (Actual)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vejle Hospital

Collaborators

Region of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cardiological assessment

Arm Type

Experimental

Arm Description

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

Arm Title

Standard treatment

Arm Type

No Intervention

Arm Description

Standard chemotherapeutic treatment

Intervention Type

Procedure

Intervention Name(s)

Cardiologic assessment

Intervention Description

Aggressive ischemic risk factor management

Primary Outcome Measure Information:

Title

Acute coronary syndrome

Description

Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Chest pain

Description

Incidence of chest pain

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mads D Lyhne, MD

Phone

+45 20450486

Mads.Dam.Lyhne@rsyd.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Vibeke B Hansen, MD, PhD

vibeke.brogaard.hansen@rsyd.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vibeke B Hansen, MD, PhD

Organizational Affiliation

Vejle Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lars H Jensen, MD, PhD

Organizational Affiliation

Department of Oncology, Vejle Hospital, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Departments of Oncology and Medicine, Vejle Hospital

City

Vejle

Country

Denmark

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prevention of Chest Pain in Chemo-treated Cancer Patients

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