Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

Study Overview
=================
Brief Summary
-----------------
Exploring effective risk prediction models for severe RTOM, providing a research basis for mitigating oral radiation toxicity, and effectively improving the sensitivity of dentists in predicting the risk of severe RTOM in locally advanced nasopharyngeal carcinoma patients.Based on precise radiotherapy, it is proposed to extract OAR using the contour of local oral areas. Explore more accurate RTOM dose-response relationships.Exploring a new type of fusion classifier, by complementing the information between each base classifier, helps to maximize the utilization of the information contained in different factors to build a more objective, reliable, and efficient multi criteria decision-making based risk prediction model for severe RTOM.

Official Title
-----------------
Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma by AJCC V8 Stage

Intervention / Treatment
-----------------
* Other: Routine oral care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed as nasopharyngeal carcinoma through pathological tissue biopsy, AJCC 8th edition bed staging is I-Iva stage, with no distant metastasis First time receiving radical radiation therapy and receiving RTOM observation and treatment throughout the entire process in the Department of Stomatology Complete information on anti-tumor treatment materials No oral mucosal diseases that have not been effectively controlled in the past or still require long-term medication treatment Other diseases that do not affect the treatment of nasopharyngeal carcinoma Exclusion Criteria: Failure to complete radiotherapy, or material release time delayed by more than two weeks compared to plan There are other diseases that affect the examination and treatment of oral mucosal inflammation, such as restricted mouth opening, Schegren's syndrome, etc Expected survival time less than 6 months Cases where patients withdraw from clinical trials at any time and for any reason

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe RTOM<br>The oral evaluation of all patients was conducted by the same senior dentist, who evaluated the oral mucosal radiation toxicity weekly at baseline (before RT) and after RT, and performed RTOM scores.RTOM is classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0). RTOM is divided into four levels: 0 (no oral mucosal inflammation), I (mucosal erythema), II (mucosal pseudomembranous reaction, plaque ≤ 1.5cm, discontinuous) Level III (fusion pseudomembrane reaction, continuous plaque diameter>1.5cm), Level IV (necrosis or deep ulcer or accompanied bleeding, excluding bleeding caused by trauma), among which RTOM above level III is classified as severe RTOM. | Other: Routine oral care<br>* During the radiotherapy period, all patients received pain management, diet consultation and appropriate dental preventive management every week by radiologists, dietitian and dentists, and all patients completed treatment unrelated to the severity of mucositis.<br>|
| Non Severe RTOM<br>The oral evaluation of all patients was conducted by the same senior dentist, who evaluated the oral mucosal radiation toxicity weekly at baseline (before RT) and after RT, and performed RTOM scores.RTOM is classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) . RTOM is divided into four levels: 0 (no oral mucositis), I (mucosal erythema), II (mucosal pseudomembranous reaction, plaque ≤ 1.5cm, discontinuous) Grade III (fusion pseudomembrane reaction, continuous plaque diameter>1.5cm), Grade IV (necrosis or deep ulcer or accompanied bleeding, excluding bleeding caused by trauma), of which Grade I and II are non severe RTOM. | Other: Routine oral care<br>* During the radiotherapy period, all patients received pain management, diet consultation and appropriate dental preventive management every week by radiologists, dietitian and dentists, and all patients completed treatment unrelated to the severity of mucositis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe RTOM | According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM | during radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of severe RTOM | Patient factors, disease factors, and treatment related factors | baseline (before radiotherapy) |