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

Recruiting

• Conditions: Radiation Induced Mucositis; Nasopharyngeal Carcinoma by AJCC V8 Stage
• Interventions: Other: Intervention based on key factors identified by the severe RIOM prediction model

• Registration Number: NCT05858385
• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Brief Summary

Exploring effective risk prediction models for severe Radiation-Induced Oral Mucositis (RIOM/RTOM), providing a research basis for mitigating oral radiation toxicity, and effectively improving the sensitivity of dentists in predicting the risk of severe RIOM 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 RIOM 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 RIOM. It use predictive models to identify key risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive mode.

Detailed Description

This study investigates the prediction and management of Radiation-Induced Oral Mucositis (RIOM/RTOM) in patients with locally advanced nasopharyngeal carcinoma undergoing radiotherapy. RIOM is a significant concern due to its impact on the quality of life for patients and its potential to disrupt radiotherapy courses, affecting local tumor control rates. We systematically analyzed multifaceted data, including dosimetric parameters, clinical factors, and oral variables, to develop a predictive model for severe RIOM. The effectiveness of key risk factors in mitigating the risk of severe RIOM was further validated to predict and potentially prevent severe RIOM.

Study Timeline

• Study Start: 2022-09-22
• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Development and Validation of severe RIOM prediction model	Intervention based on key factors identified by the severe RIOM prediction model	This group aims to develop an artificial intelligence model using a retrospective cohort to predict severe RIOM in patients diagnosed with LA-NPC and evaluate risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive model.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 RIOM scores.RIOM is classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) .

Primary Outcome Measures

Name	Time	Method
Incidence of severe RIOM	during radiotherapy	According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM

Secondary Outcome Measures

Name	Time	Method
Risk factors of severe RIOM	baseline (before radiotherapy)	Patient factors, disease factors, and treatment related factors

Trial Locations

Locations (1)

Yu Zeng; 🇨🇳 Guangzhou, Guangdong, China