Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06767488

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

Led by Nanfang Hospital, Southern Medical University · Updated on 2025-01-10

375

Participants Needed

1

Research Sites

72 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent
  • Age 18 to 75 years
  • Histologically confirmed head and neck tumors
  • Receiving radiotherapy or chemoradiotherapy
  • ECOG Performance Status Score of 0, 1, or 2
Not Eligible

You will not qualify if you...

  • Lung diseases such as lung cancer, tuberculosis, or lung infections
  • Inhalation anesthesia within the past 3 months
  • Use of inhalation medication within the past 3 months
  • Postoperative laryngeal cancer
  • Serious uncontrolled medical conditions like unstable heart disease needing treatment
  • Poorly controlled diabetes with fasting blood glucose greater than 1.5 times the upper limit of normal
  • Investigator judges participation as inappropriate

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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