Using breath analysis to predict mouth sores from radiotherapy in head and neck cancer patients
Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors
Nanfang Hospital, Southern Medical University · NCT06767488
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 |
|---|---|
| Enrollment | 375 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06767488 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed head and neck tumors who are receiving radiotherapy or chemoradiotherapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Nanfang hospital, Southern medical university — Guangzhou, Guangdong, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Tumors, Breathomics, Volatile Organic Compounds, Radiotherapy-induced Oral Mucositis