About this trial
Radiotherapy-Induced Oropharyngeal Mucositis (RIOM) is one of the most distressing side effects for patients with head and neck tumors during radiotherapy, requiring clinical physicians to manage it according to the severity of mucositis to alleviate symptoms and improve quality of life. However, traditional diagnosis of RIOM overly relies on subjective evaluation, lacks early sensitivity, and existing biomarker diagnostic methods suffer from insufficient efficacy, invasiveness, and inconsistent results. This study aims to explore the diagnostic and predictive value of exhaled breathomics in RIOM of head and neck tumors. By collecting exhaled breath samples from head and neck tumor patients undergoing radiotherapy and analyzing volatile organic compounds (VOCs) using breath detection technology, we aim to develop and validate a non-invasive diagnostic and predictive model based on exhaled breathomics. The study will identify specific VOCs as potential biomarkers, providing new tools for early diagnosis, timely prediction, and personalized treatment of RIOM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign informed consent. Over 18 years of age. Histologically confirmed head and neck tumors, treated with radiotherapy or chemoradiotherapy.
Disqualifiers
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).
Trial population
Patients with head and neck tumors requiring radiotherapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Different grades radiotherapy-induced oral mucositis
The incidence rates of radiation-induced oral mucositis across various severity grades will be determined.
Secondary outcomes
Start and duration of radiotherapy-induced oral mucositis
Calculated the onset time and duration of radiotherapy-induced oral mucositis.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.