Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose and predict a painful side effect called Radiotherapy-Induced Oropharyngeal Mucositis (RIOM) that affects patients with head and neck tumors during their treatment. The researchers want to see if they can use breath samples to find specific compounds in the breath, known as volatile organic compounds (VOCs), that could help identify when a patient is likely to develop RIOM. This method could provide a non-invasive (meaning no needles or surgery) way to detect and predict this condition early, allowing for better management and personalized treatment.

To participate in the trial, individuals must be over 18 years old and have a confirmed diagnosis of head and neck tumors that are being treated with radiotherapy. They also need to be in relatively good health, with a performance status that indicates they can carry out daily activities. However, people with certain lung diseases, recent inhalation anesthesia, or uncontrolled serious medical conditions may not be eligible. Participants will provide breath samples during their treatment, and the study aims to create a new tool that could improve the care and comfort of patients facing this challenging side effect.

Gender

ALL

Eligibility 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.