RecruitingNCT06767488

Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

375 participants

Start Date

Dec 6, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Radiotherapy-Induced Oropharyngeal Mucositis (RIOM) is one of the most distressing side effects for patients with head and neck tumors during radiotherapy, requiring clinical physicians to manage it according to the severity of mucositis to alleviate symptoms and improve quality of life. However, traditional diagnosis of RIOM overly relies on subjective evaluation, lacks early sensitivity, and existing biomarker diagnostic methods suffer from insufficient efficacy, invasiveness, and inconsistent results. This study aims to explore the diagnostic and predictive value of exhaled breathomics in RIOM of head and neck tumors. By collecting exhaled breath samples from head and neck tumor patients undergoing radiotherapy and analyzing volatile organic compounds (VOCs) using breath detection technology, we aim to develop and validate a non-invasive diagnostic and predictive model based on exhaled breathomics. The study will identify specific VOCs as potential biomarkers, providing new tools for early diagnosis, timely prediction, and personalized treatment of RIOM.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using breathomics — analysis of compounds in exhaled breath — to see if it can help diagnose and predict radiation-related side effects in the mouth and throat (oropharyngeal mucositis) in head and neck cancer patients receiving radiotherapy. It is a non-invasive observational study. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with a head or neck tumor confirmed by biopsy - You are receiving or have received radiotherapy or chemoradiotherapy for your tumor - Your general health is reasonably good (ECOG score 0, 1, or 2) **You may NOT be eligible if...** - You have a lung condition such as lung cancer, tuberculosis, or active lung infection - You have used inhaled anesthesia or inhaled medication within the past 3 months - You have had laryngeal cancer surgery (laryngectomy) - You have poorly controlled diabetes or a serious uncontrolled heart condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China

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NCT06767488


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