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

NCT07690631 | Not Yet Recruiting

• 1 other identifier: MICRORAD
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Microplastic Exposure; Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• MNPs effect on head and neck cancer patiens

  To characterize MNPs and trace their biodistribution and to correlate MNP exposure with treatment outcomes

  From enrollment to the 6 month FU treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with head and neck malignancies undergoing radiation therapy

You may qualify if:

• Any stage head and neck cancer patients
• Eastern Cooperative Oncology Group performance status 0-2
• Undergoing radiotherapy with/without cisplatin chemopotentiation
• Signed informed consent

You may not qualify if:

• Pregnancy or lactation
• Mental illness
• Prior or concurrent malignancies
• Immunotherapy or immunosuppressive therapy
• Immune diseases

Sponsors & Collaborators

• University of Kragujevac: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, skin swab

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Marija N Zivkovic Radojevic, Assistant Professor, MD PhD

CONTACT

+381658384450; makizivkovicmarija@gmail.com

Neda Milosavljevic, Assistant Professor, MD PhD

CONTACT

+381638429691; neda.milosavljevic@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 15, 2026

Record last verified: 2026-02