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

Recruiting

• Conditions: Head and Neck Tumors; Breathomics; Volatile Organic Compounds; Radiotherapy-induced Oral Mucositis

• Registration Number: NCT06767488
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-06
• Study First Submitted: 2024-12-15
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Different grades radiotherapy-induced oral mucositis	Through study completion, up to 1 year	The incidence rates of radiation-induced oral mucositis across various severity grades will be determined.

Secondary Outcome Measures

Name	Time	Method
Start and duration of radiotherapy-induced oral mucositis	Through study completion, up to 1 year	Calculated the onset time and duration of radiotherapy-induced oral mucositis.

Trial Locations

Locations (1)

Nanfang hospital, Southern medical university; 🇨🇳 Guangzhou, Guangdong, China