Using breath analysis to predict mouth sores from radiotherapy in head and neck cancer patients
Official title: Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors
Run by Nanfang Hospital, Southern Medical University · NCT06767488 · Data updated 2026-11-12
This study is testing whether analyzing breath samples can help predict mouth sores in head and neck cancer patients receiving radiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 375 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 6, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | April 30, 2026 |
| Registry record updated | January 10, 2025 |
| Trial ID | NCT06767488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with histologically confirmed head and neck tumors who are receiving radiotherapy or chemoradiotherapy.
✕Probably not a fit
Patients with lung diseases, recent inhalation anesthesia or medication, postoperative laryngeal cancer, or serious uncontrolled medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the use of breath analysis to diagnose and predict radiotherapy-induced oropharyngeal mucositis in patients with head and neck tumors. By collecting exhaled breath samples, researchers will analyze volatile organic compounds (VOCs) to identify potential biomarkers for this painful side effect of treatment. The goal is to develop a non-invasive diagnostic model that can provide early detection and improve patient management during radiotherapy. This approach aims to enhance the quality of life for patients by addressing the limitations of current diagnostic methods.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive method for early diagnosis and prediction of painful mouth sores in head and neck cancer patients undergoing radiotherapy.
How similar studies have gone: While the use of breath analysis in medical diagnostics is an emerging field, this specific approach to predict radiotherapy-induced mucositis is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntarily sign informed consent. Over 18 years of age. Histologically confirmed head and neck tumors, treated with radiotherapy or chemoradiotherapy. ECOG PS Score: 0/1/2. Exclusion Criteria: * Lung disease such as lung cancer, tuberculosis, and lung infections. Inhalation anesthesia within 3 months. Inhalation medication within 3 months. Postoperative laryngeal cancer. Concurrent serious uncontrolled medical conditions such as unstable heart disease requiring treatment, poorly controlled diabetes mellitus (fasting blood glucose \> 1.5 x upper limit of normal). Participation deemed inappropriate in the judgment of the investigator.
Where it's running
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Nanfang hospital, Southern medical university
Guangzhou, Guangdong, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.