Clinical trial · Observational
Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma by AJCC V8 Stage | Nasopharyngeal Carcinoma by AJCC v8 Stage | ONTOLOGY_EXACT | 0.98 |
| Radiation Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention based on key factors identified by the severe RIOM prediction model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Development and Validation of severe RIOM prediction model
- description
- 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) .
- interventionNames
- Other: Intervention based on key factors identified by the severe RIOM prediction model
Primary outcomes (1)
- measure
- Incidence of severe RIOM
- timeFrame
- during radiotherapy
- description
- According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZeng Y, Hu Y, Wang L, Liao Z, Tan J, Kuang Y, Gong P, Qi B, Zhen X. Control of dental calculus Prevents severe Radiation-Induced oral mucositis in patients undergoing radiotherapy for nasopharyngeal carcinoma. Radiother Oncol. 2025 Jun;207:110872. doi: 10.1016/j.radonc.2025.110872. Epub 2025 Mar 27. PMID 40157544