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

NCT07407218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-02-17

No results posted yet for this study

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)

Interventions

RADIATION

Radical (Chemo)Radiotherapy

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.

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07407218 on ClinicalTrials.gov