Using a patient's oral microbiota to guide radiotherapy for head and neck cancer
MIcrobiota-Guided RAdiotherapy for Head and Neck Cancer. (MIGRHAN)
We will test whether profiling the oral microbiota before radiotherapy can help predict and reduce side effects and improve treatment response for adults with head and neck cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT07253402 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with histologically confirmed head and neck cancers who are planned for definitive or adjuvant external beam radiotherapy and have ECOG performance status ≤3 are the intended participants.
Not a fit: Patients with metastatic disease, those not receiving radiotherapy, or those unable to attend the Milan center for sample collection are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, this work could enable personalized radiotherapy planning and microbiota-targeted strategies that reduce oral mucositis and improve tumor control.
How similar studies have performed: Previous observational studies have reported associations between oral microbiota and head and neck cancer outcomes, but causal links remain unproven and this functional metagenomics plus causal-inference approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.