Clinical trial · Observational
Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Head and Neck Carcinoma
Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (COMRAD-HNSCC)
- 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)
Preclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. In this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed together with bacterial metabolites in stool and blood and a possible correlation with treatment outcome and treatment toxicity will be determined.
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 Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Objective response rate
- timeFrame
- 3 months post-treatment
- description
- Objective response rate to radiotherapy according to RECIST 1.1 criteria as measured with computed tomography. Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between responders and non-responders.
- measure
- Acute radiation induced mucositis and dermatitis
- timeFrame
- Up to 3 months post-treatment
- description
- Acute radiation induced mucositis and dermatitis according to CTCAE v3.0 as measured with clinical examination. Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between patients with a maximum Grade ≤ 2 versus those with a maximum Grade \> 3 acute radiation induced mucositis and dermatitis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written and voluntary informed consent. * Patient must be willing and able to provide collection for stool specimen analyses at 2 time points. * Age \> 18 years, male or female. * Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, or nasopharynx). * Patients must be eligible for curative-intent treatment with either radiotherapy or concurrent chemo-radiotherapy. * Overall disease stage III-IV based on 8th edition of American Joint Committee on Cancer staging system. Exclusion Criteria: * Receipt of induction chemotherapy. * Presence of distant metastases. * Any previous head and neck cancer. * Any other known concurrent malignant disease. * Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
References
Publications (0)
Data not yet available