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

NCT05858385 | Recruiting

• 1 other identifier: oral mucositis
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage; Radiation Induced Mucositis

Outcome Measures

Primary Outcomes (1)

• Incidence of severe RIOM

  According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM

  during radiotherapy

Secondary Outcomes (1)

• Risk factors of severe RIOM

  baseline (before radiotherapy)

Other Outcomes (3)

• Changes from oral dryness in RIOM patients

  Baseline, the 10th, 20th and 30th days of radiotherapy

• Changes from salivary PH compared to baseline in RIOM patients

  Baseline, the 10th, 20th and 30th days of radiotherapy

• Changes from the pain in xerostomia combined with RIOM patients

  Baseline, the 10th, 20th and 30th days of radiotherapy

Study Arms (1)

Development and Validation of 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) .

Other: Intervention based on key factors identified by the severe RIOM prediction model

Interventions

Intervention based on key factors identified by the severe RIOM prediction model OTHER

Intervention based on key factors identified by the severe RIOM prediction model

Development and Validation of severe RIOM prediction model

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Nasopharyngeal cancer patients diagnosed with tissue biopsy and no distant metastasis, who underwent RTOM observation and treatment throughout the radiotherapy period in the Department of Stomatology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Yu Zeng

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

• Zeng 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 DERIVED

Study Design

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

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 15, 2023
• Study Start: September 22, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)