Actively Recruiting
Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-01-10
375
Participants Needed
1
Research Sites
17 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 experienced by patients with head and neck tumors during radiotherapy. This study aims to explore the use of exhaled breathomics—specifically analyzing volatile organic compounds (VOCs)—to diagnose and predict RIOM. The goal is to develop a non-invasive and early detection model that could help improve symptom management and personalize treatment for affected patients. The study involves collecting breath samples from patients with confirmed head and neck tumors who are undergoing radiotherapy or chemoradiotherapy. These samples will be analyzed using breath detection technology to identify specific VOCs that may serve as biomarkers for RIOM. The research will focus on validating this diagnostic and predictive model throughout the treatment period. Participants will be monitored for different grades of oral mucositis caused by radiotherapy, with assessments lasting up to one year. The study will record the onset and duration of mucositis symptoms. Researchers will evaluate the breath samples alongside clinical observations to understand the relationship between VOCs and mucositis severity. This observational study does not involve treatment changes but focuses on detailed data collection and follow-up.
CONDITIONS
Brief 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
- Be 18 to 75 years old
- Have histologically confirmed head and neck tumors
- Be treated with radiotherapy or chemoradiotherapy
- Have an ECOG Performance Status score of 0, 1, or 2
You will not qualify if you...
- Have lung diseases such as lung cancer, tuberculosis, or lung infections
- Have received inhalation anesthesia within the last 3 months
- Have used inhalation medication within the last 3 months
- Have postoperative laryngeal cancer
- Have serious uncontrolled medical conditions such as unstable heart disease needing treatment
- Have poorly controlled diabetes mellitus with fasting blood glucose above 1.5 times the upper limit of normal
- Be deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants are observed during and after radiotherapy to assess the development and progression of oral mucositis related to their treatment.
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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