Using a patient's oral microbiota to guide radiotherapy for head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-institution observational study will collect oral microbiota samples and clinical data from adults with head and neck cancer who are scheduled to receive external beam radiotherapy. Researchers will perform functional metagenomic analyses of the oral microbiota and apply causal-inference statistical methods to link microbial functions with outcomes such as oral mucositis severity and tumor control. The goal is to identify microbiota features that predict intolerable side effects or unfavorable outcomes and to infer possible biological mechanisms. Findings are intended to inform future personalized radiotherapy plans and microbiota-targeted interventions like probiotics, antibiotics, or dietary supplements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* ECOG Performance Status ≤ 3.
* Histological diagnosis of squamous cell carcinoma, undifferentiated carcinoma, epithelial glandular and non-glandular carcinoma (including adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, neuroendocrine carcinoma, etc.) originating from the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary glands, paranasal sinuses, or from an unknown primary site.
* Stage III-IV non-metastatic disease for pharyngeal, laryngeal, or unknown-primary tumors, according to AJCC 7th edition. Patients with stage III-IV tumors of salivary gland or paranasal sinus origin, and patients with stage I-II pharyngeal or laryngeal tumors, will only be included if prophylactic irradiation of cervical lymph node stations is indicated and/or if the oral and oropharyngeal mucosa as well as swallowing-related structures are included within the irradiated volume.
* Indication for treatment in either definitive or adjuvant settings, with or without systemic therapy (concurrent systemic therapy, with or without prior neoadjuvant chemotherapy, permitted. Adjuvant systemic therapy is allowed for selected advanced stages of pharyngeal carcinoma, according to institutional guidelines).
* Formal acceptance of study participation requirements (written informed consent).

Exclusion Criteria:

* Prior radiotherapy to the head-neck region.
* Presence of connective tissue disorders (e.g., lupus erythematosus or scleroderma) or synchronous head and neck malignancies, except for superficial skin cancers or surgically treated carcinoma in situ not requiring radiotherapy or systemic therapy.
* Absence of formal acceptance of study participation requirements (written informed consent).
* Indication for treatment exclusively in the postoperative setting.

Where it's running

• Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
  Milan, Milan, Italy Recruiting

Study contacts

• Principal investigator: Jacopo Iacovacci, PhD — Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
• Study coordinator: Jacopo Iacovacci, PhD
• Email: jacopo.iacovacci@istitutotumori.mi.it
• Phone: +39 02-23902994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.