Actively Recruiting
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
Eligibility Criteria
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
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
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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