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

NCT06767488 | Recruiting

• 1 other identifier: NFEC-2024-581
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Different grades radiotherapy-induced oral mucositis

  The incidence rates of radiation-induced oral mucositis across various severity grades will be determined.

  Through study completion, up to 1 year

Secondary Outcomes (1)

• Start and duration of radiotherapy-induced oral mucositis

  Through study completion, up to 1 year

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with head and neck tumors requiring radiotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

exhaled breath samples

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 10, 2025
• Study Start: December 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

CN (1)