Clinical trial · Observational
Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:
- 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)
MICRORAD is a pioneering 48-month translational research project that investigates the potential health and environmental impacts of micro- and nanoplastics (MNPs) released from medical devices when exposed to ionizing radiation. In radiation oncology, thermoplastic masks (TPMs) are standard immobilization tools, particularly for head and neck (HN) cancer patients. Globally, approximately 2.65 million TPMs are used annually in the radiotherapy of HN cancer patients and with an additional 8 to 10 million for other tumor types. TPMs are repeatedly subjected to high-energy X-rays and frequent handling, raising concerns about polymer degradation and the release of MNPs, which may interfere with treatment efficacy or contribute to radiation toxicity. MICRORAD is the first translational study to explore this phenomenon by integrating clinical oncology, materials science, radiobiology, and data science. The project will analyze radiation-induced changes in TPMs, quantify MNP release, and assess their biological effects through in vitro, in vivo, and clinical studies. Using advanced detection techniques, the project will characterize MNPs and trace their biodistribution, while a clinical pilot will correlate MNP exposure with treatment outcomes. Data integration, biostatistics, and AI-based modeling will support the translation of findings into clinical guidelines, policy briefs, and public communication. A multidisciplinary team will collaborate to ensure real-world impact. By bridging oncology and environmental health, MICRORAD aims to establish eco-oncology as a new field, contributing to patient safety and sustainable innovation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Microplastic Exposure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- MNPs effect on head and neck cancer patiens
- timeFrame
- From enrollment to the 6 month FU treatment
- description
- To characterize MNPs and trace their biodistribution and to correlate MNP exposure with treatment outcomes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any stage head and neck cancer patients * Eastern Cooperative Oncology Group performance status 0-2 * Undergoing radiotherapy with/without cisplatin chemopotentiation * Signed informed consent Exclusion Criteria: * Pregnancy or lactation * Mental illness * Prior or concurrent malignancies * Immunotherapy or immunosuppressive therapy * Immune diseases
References
Publications (0)
Data not yet available