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Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:

Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07690631
Acronym
MICRORAD
Enrollment
500
Registered
2026-07-08
Start date
2026-09-01
Completion date
2030-10-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Microplastic Exposure

Keywords

Head and neck cancer, Microplastics, thermoplastics mask, MICRORAD, MNPs

Brief summary

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.

Interventions

None listed

Sponsors

University of Kragujevac
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
MNPs effect on head and neck cancer patiensFrom enrollment to the 6 month FU treatmentTo characterize MNPs and trace their biodistribution and to correlate MNP exposure with treatment outcomes

Contacts

CONTACTMarija N Zivkovic Radojevic, Assistant Professor, MD PhD
makizivkovicmarija@gmail.com+381658384450
CONTACTNeda Milosavljevic, Assistant Professor, MD PhD
neda.milosavljevic@yahoo.com+381638429691

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026