Clinical trial · Interventional
Fecal Microbiota And Metabolites In Head And Neck Cancer Patients Receiving (Chemo)Radiotherapy
The Effect Of Fecal Microbiota And Selected Metabolites On Efficacy And Toxicity Of Radiotherapy In Head And Neck Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer (H&N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical (Chemo)Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radical (Chemo)Radiotherapy With Microbiome and Metabolite Assessment
- description
- 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.
- interventionNames
- Radiation: Radical (Chemo)Radiotherapy
Primary outcomes (2)
- measure
- Treatment Response
- timeFrame
- 3 months after completion of (chemo)radiotherapy
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Planned induction chemotherapy * Failure to complete radical (chemo)radiotherapy treatment
References
Publications (0)
Data not yet available