NCT07407218Completed
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 · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 6 Feb 2026
- Start date
- 1 Sept 2021
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Head and neck cancer
- NCT number
- NCT07407218
What you commit to
- Study type: Interventional
- Participants enrolled: 58
- From 1 Sept 2021 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned induction chemotherapy
Other illness
- Failure to complete radical (chemo)radiotherapy treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.