Clinical trial · Interventional
Prevention of Chest Pain in Chemo-treated Cancer Patients
Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 5-Fluorouracil Toxicity | — | UNRESOLVED | — |
| Acute Coronary Syndrome | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Chest Pain | — | UNRESOLVED | — |
| Coronary Artery Calcification | — | UNRESOLVED | — |
| Solid Carcinoma | Solid Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiologic assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cardiological assessment
- description
- a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment
- interventionNames
- Procedure: Cardiologic assessment
- type
- NO_INTERVENTION
- label
- Standard treatment
- description
- Standard chemotherapeutic treatment
Primary outcomes (1)
- measure
- Acute coronary syndrome
- timeFrame
- 6 months
- description
- Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLyhne 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. PMID 40382663