Solid CarcinomaCATCHNCT03486340
Prevention of Chest Pain in Chemo-treated Cancer Patients
A study testing Cardiologic assessment in people with Solid Carcinoma and 5-Fluorouracil Toxicity, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Carcinoma, 5-Fluorouracil Toxicity, Cardiotoxicity
- What is being tested?
- Cardiologic assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Apr 2018to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified cancer
- First-time treatment with 5-FU/Capecitabine
- Expected remaining lifetime > 6 months
- Informed consent
Who cannot join
- Known ischemic heart disease
- Ischemia-suspicious symptoms prior to 5-FU treatment
- Ischemia-suspicious ECG-changes prior to 5-FU treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil
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
- Being tested
- Cardiologic assessment
- Medical subject headings
- Cardiotoxicity, Acute Coronary Syndrome, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiologic assessmentProcedure or surgery
Aggressive ischemic risk factor management
| Study group | Role | What they receive |
|---|---|---|
| Cardiological assessment | Experimental | a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment Receives: Procedure: Cardiologic assessment |
| Standard treatment | No intervention | Standard chemotherapeutic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Chest pain
Incidence of chest pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start11 Apr 2018
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Vibeke B Hansen, MD, PhD, Principal investigator, Vejle HospitalLars H Jensen, MD, PhD, Study chair, Department of Oncology, Vejle Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486340
- Sponsor's protocol ID
- CATCH2018
- Acronym
- CATCH
- Status last verified
- Jul 2024
- First submitted
- 26 Mar 2018
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyhne JD, Hansen VB, Vestergaard LD, Hosbond SE, Busk M, Gnanaganesh M, Maae E, Havelund BM, Hansen TF, Timm S, Jensen LH, Lyhne MD. Primary prevention of cardiotoxicity in cancer patients treated with fluoropyrimidines: a randomized controlled trial. Cardiooncology. 2025 May 17;11(1):48. doi: 10.1186/s40959-025-00344-3.
PubMed 40382663
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil
- ClinicalTrials.gov ID
- NCT03486340
- Acronym / sponsor ID
- CATCH / CATCH2018
- Conditions
- Solid Carcinoma, 5-Fluorouracil Toxicity, Cardiotoxicity, Chemotherapeutic Toxicity, Acute Coronary Syndrome, Coronary Artery Calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiological assessment | Experimental | Procedure: Cardiologic assessmenta sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment |
| Standard treatment | No intervention | –Standard chemotherapeutic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically verified cancer
- First-time treatment with 5-FU/Capecitabine
- Expected remaining lifetime > 6 months
- Informed consent
Key exclusion criteria (3 listed)
- Known ischemic heart disease
- Ischemia-suspicious symptoms prior to 5-FU treatment
- Ischemia-suspicious ECG-changes prior to 5-FU treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiologic assessmentAggressive ischemic risk factor management | Procedure or surgery | Cardiological assessment |
Primary outcome
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
1 secondary outcome
Chest pain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 40382663Lyhne JD, Hansen VB, Vestergaard LD, Hosbond SE, Busk M, Gnanaganesh M, Maae E, Havelund BM, Hansen TF, Timm S, Jensen LH, Lyhne MD. Primary prevention of cardiotoxicity in cancer patients treated with fluoropyrimidines: a randomized controlled trial. Cardiooncology. 2025 May 17;11(1):48. doi: 10.1186/s40959-025-00344-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke B Hansen, MD, PhD principal investigator
Vejle Hospital
Lars H Jensen, MD, PhD study chair
Department of Oncology, Vejle Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiologic assessment in people with Solid Carcinoma and 5-Fluorouracil Toxicity, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute coronary syndrome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03486340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.