Clinical trial Recruiting at 1 site Observational Ages 18 to 75

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.

More Head and Neck Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment375 (estimated)
SponsorNanfang Hospital, Southern Medical University
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedDecember 6, 2024
Main results expectedDecember 31, 2025
Study endsApril 30, 2026
Registry record updatedJanuary 10, 2025
Trial IDNCT06767488 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

  • Nanfang hospital, Southern medical university
    Guangzhou, Guangdong, China
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.