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

Head and Neck Cancer Clinical Trial

Official title:

A Comparative Study on the Evaluation Consistency Between the New Type and the Traditional Grade of Radioactive Oropharyngeal Mucositis and the Exploration of Blood Markers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307327
• Other study ID #: NFEC-2024-098
• Status: Recruiting
• Start date: March 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Jian Guan, M.D
• Phone: +86-13632102247
• Email: guanjian5461[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 894
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Radiation-Induced Mucositis

Locations

Country	Name	City	State
China	Southern medical university	Guangzhou	Guangdong
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation consistency	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.	Through study completion, up to 3 years