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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiological assessment | Experimental | a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment |
|
| Standard treatment | No Intervention | Standard chemotherapeutic treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiologic assessment | Procedure | Aggressive ischemic risk factor management |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chest pain | Incidence of chest pain | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vibeke B Hansen, MD, PhD | Vejle Hospital | Principal Investigator |
| Lars H Jensen, MD, PhD | Department of Oncology, Vejle Hospital, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of Oncology and Medicine, Vejle Hospital | Vejle | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40382663 | Derived | 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. |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |