Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis

Recruiting now

Conditions studied: Head and Neck Cancer, Radiation-Induced Mucositis

In brief

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

Key facts

Study ID

NCT06307327

Run by

Nanfang Hospital, Southern Medical University

People needed

264

Starts

2025-09-01

Expected to finish

2026-12-01

Last updated by the study team

2025-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily sign informed consent;
• Age 18 or older on the date of signing the informed consent;
• Histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy.

You may not qualify if…

• They also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose > 1.5× the upper limit of normal), mental illness, and a history of severe allergies

Where it is running

• Southern medical university — Guangzhou, Guangdong, China (enrolling)
• Huizhou Central People's Hospital — Huizhou, Guangdong, China
• Jieyang people's hospital — Jieyang, Guangdong, China
• Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou, Guangdong, China

Full record on ClinicalTrials.gov

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