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

Recruiting

• Conditions: Head and Neck Cancer; Radiation-Induced Mucositis

• Registration Number: NCT06307327
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors, and it needs to be treated according to the severity of mucositis to reduce symptoms and improve quality of life. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency, which seriously restricts doctors' correct evaluation and treatment of mucositis patients. 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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-12
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 894

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation consistency	Through study completion, up to 3 years	Different physician assessments of agreement (percentage) were directly compared between the new and traditional classifications. Consistency refers to the proportion of assessments made by two doctors that are the same.

Trial Locations

Locations (4)

Jieyang people's hospital; 🇨🇳 Jieyang, Guangdong, China

Southern medical university; 🇨🇳 Guangzhou, Guangdong, China

Huizhou Central People's Hospital; 🇨🇳 Huizhou, Guangdong, China

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou; 🇨🇳 Meizhou, Guangdong, China