Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Head and Neck Carcinoma

Head and Neck Squamous Cell Carcinoma Clinical Trial

— COMRAD-HNSCC  

Official title:

Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (COMRAD-HNSCC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05156177
• Other study ID #: ERIDEK-0052/2021
• Status: Active, not recruiting
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Institute of Oncology Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Head and neck cancer patients commonly present with unresectable locoregionally advanced disease in which radiotherapy is the mainstay of curative-intent treatment albeit at the cost of substantial acute and late toxicity. Recently discovered mechanisms by which gut microbiota and its metabolites impact tumor's and normal tissue's response to radiotherapy offer new ways to improve the therapeutic index of radiotherapy in solid tumors.

COMRAD-HNSCC is a prospective study assessing the correlation between gut microbiota composition and its metabolites and the response to radiotherapy in patients with unresectable locoregionally advanced head and neck cancer. Stool and serum samples will be collected at the beginning and at the end of curative radiotherapy treatment. The composition of gut microbiota will be analysed by ribosomal DNA high-throughput amplicon sequencing of the DNA isolated from stool samples, whereas targeted metabolomics using liquid chromatography-mass spectrometry will be performed on stool and serum samples.

The long-term goal of this study is to deepen the understanding of the role of gut microbiome and its metabolites in efficacy and toxicity of radiotherapy in head and neck cancer, and provide a basis for subsequent exploration to increase therapeutic index by regulating gut microbiota.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
Slovenia	Institute of Oncology Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	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.	3 months post-treatment
Primary	Acute radiation induced mucositis and dermatitis	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.	Up to 3 months post-treatment