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

NCT06307327 | Recruiting

• 1 other identifier: NFEC-2024-098
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Cancer; Radiation-Induced Mucositis

Keywords

Radiation oropharyngeal mucositis; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Inter-rater consistency among doctors

  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

Secondary Outcomes (4)

• Consistency in assessment between doctors and patients

  Through study completion, up to 3 years

• The assessment period

  Through study completion, up to 3 years

• the satisfaction of patients

  Through study completion, up to 3 years

• the satisfaction of doctors

  Through study completion, up to 3 years

Other Outcomes (1)

• Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis

  Through study completion, up to 3 years

Eligibility Criteria

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

Study Population

The subjects in this study were head and neck tumor patients receiving radiotherapy

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (4)

Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

Huizhou Central People's Hospital

Huizhou, Guangdong, 516000, China

NOT YET RECRUITING

Jieyang people's hospital

Jieyang, Guangdong, 522000, China

NOT YET RECRUITING

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou

Meizhou, Guangdong, 514000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jian Guan, M.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Guan, M.D

CONTACT

+86-13632102247; guanjian5461@163.com

Study Design

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

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)