Fecal Microbiota And Metabolites In Head And Neck Cancer Patients Receiving (Chemo)Radiotherapy

NCT07407218 | Completed

• 2 other identifiers: OI-LJ-HN-MICROBIOME-2021ERIDSPRA-0087/2021
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study investigates whether the composition of the fecal microbiome and selected bacterial metabolites are associated with the efficacy and acute toxicity of radiotherapy in patients with locally advanced head and neck cancer treated with radical (chemo)radiotherapy. Increasing evidence suggests that gut bacteria and their metabolites may influence treatment response and side effects of cancer therapies, including radiotherapy. Participants will receive standard radical radiotherapy with or without concomitant chemotherapy according to clinical guidelines. During the course of treatment, participants will provide two stool samples and two blood samples. Stool samples will be collected at home and delivered to the hospital on the day of radiotherapy. Blood samples (7 ml) will be collected during routine clinical blood draws. Samples will be analyzed to determine fecal microbiome composition using 16S rRNA sequencing and quantification of butyrate-producing bacterial genes (buk and but), as well as concentrations of short-chain fatty acids and tryptophan metabolites using targeted metabolomics. Clinical outcomes will include treatment response assessed by CT or PET-CT imaging 3 months after completion of therapy, acute toxicity (CTCAE v5.0), and follow-up survival outcomes. The study aims to identify microbiome-related biomarkers that may contribute to improved personalization of supportive interventions in the future.

Conditions

Head and Neck Cancer (H&N)

Keywords

Fecal Microbiome; Gut Microbiota

Outcome Measures

Primary Outcomes (2)

• Treatment Response

  Response to treatment assessed within routine clinical practice by CT or PET-CT imaging 3 months after completion of (chemo)radiotherapy, comparing patients with complete response versus incomplete response

  3 months after completion of (chemo)radiotherapy

• Treatment Response

  Response to treatment assessed within routine clinical practice by CT or PET-CT imaging 3 months after completion of (chemo)radiotherapy, comparing patients with complete response versus incomplete response.

  3 months after completion of (chemo)radiotherapy

Study Arms (1)

Radical (Chemo)Radiotherapy With Microbiome and Metabolite Assessment

EXPERIMENTAL

atients with locally advanced head and neck cancer treated with radical radiotherapy with or without concurrent chemotherapy will provide two stool samples and two additional blood samples (7 mL each) during the course of treatment. Stool samples will be analyzed for fecal microbiota composition using 16S rRNA gene sequencing (V3-V4 regions) and PCR quantification of butyrate-production genes (but and buk). Stool and serum samples will also be analyzed for short-chain fatty acids and tryptophan metabolites using liquid chromatography-mass spectrometry (LC-MS). Treatment response and acute toxicity will be assessed according to standard clinical practice.

Radiation: Radical (Chemo)Radiotherapy

Interventions

Radical (Chemo)Radiotherapy RADIATION

Participants receive standard radical radiotherapy for locally advanced head and neck cancer, with or without concurrent chemotherapy, according to institutional clinical practice and international guidelines. During treatment, additional stool and blood samples are collected for microbiome (16S rRNA sequencing, but/buk gene quantification) and metabolite analyses (short-chain fatty acids and tryptophan metabolites by LC-MS) to evaluate associations with treatment response and acute toxicity.

Radical (Chemo)Radiotherapy With Microbiome and Metabolite Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years)
• Carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or carcinoma metastases in cervical lymph nodes of unknown primary origin
• Overall stage III-IV according to the 8th TNM classification
• Planned radical radiotherapy with or without concomitant chemotherapy

You may not qualify if:

• Planned induction chemotherapy
• Failure to complete radical (chemo)radiotherapy treatment

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm study. All participants receive standard radical (chemo)radiotherapy according to institutional clinical practice and international guidelines. Biological samples (stool and blood) are collected at predefined time points during treatment for microbiome and metabolomics analyses.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)