Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06767488

Breath Analysis for Diagnosing and Predicting Radiotherapy-Induced Oral Mucositis in Patients with Head and Neck Tumors

Led by Nanfang Hospital, Southern Medical University · Updated on 2025-01-10

375

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Radiotherapy-Induced Oropharyngeal Mucositis (RIOM) is a common and distressing side effect for patients with head and neck tumors undergoing radiotherapy. This condition requires careful management based on mucositis severity to reduce symptoms and improve quality of life. Traditional diagnosis methods rely heavily on subjective assessments and lack early sensitivity, while current biomarker tests can be invasive, inconsistent, and less effective. The study aims to investigate how analyzing exhaled breath, specifically volatile organic compounds (VOCs), can help diagnose and predict RIOM in these patients. Patients with head and neck tumors receiving radiotherapy or chemoradiotherapy will have their exhaled breath collected and analyzed using breath detection technology. The goal is to identify specific VOCs that could serve as non-invasive biomarkers. This will help develop and validate a diagnostic and predictive model based on breathomics, potentially allowing for earlier diagnosis and more personalized treatment of RIOM. Participants will be monitored throughout their radiotherapy treatment and followed for up to one year to assess different grades of radiotherapy-induced oral mucositis. The study will involve collecting breath samples, evaluating mucositis severity, and recording clinical data. Researchers will measure outcomes related to the presence and progression of mucositis, aiming to improve early detection and management of this side effect through the breathomics approach.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent
  • Age 18 to 75 years
  • Histologically confirmed head and neck tumors
  • Receiving radiotherapy or chemoradiotherapy
  • ECOG Performance Status Score of 0, 1, or 2
Not Eligible

You will not qualify if you...

  • Lung diseases such as lung cancer, tuberculosis, or lung infections
  • Inhalation anesthesia within the past 3 months
  • Use of inhalation medication within the past 3 months
  • Postoperative laryngeal cancer
  • Serious uncontrolled medical conditions like unstable heart disease needing treatment
  • Poorly controlled diabetes with fasting blood glucose greater than 1.5 times the upper limit of normal
  • Investigator judges participation as inappropriate

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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