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

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

NCT ID: NCT05858385

Condition: Nasopharyngeal Carcinoma by AJCC V8 Stage
Radiation Induced Mucositis

Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Mucositis
Stomatitis

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Other
Intervention name: Intervention based on key factors identified by the severe RIOM prediction model
Description: Intervention based on key factors identified by the severe RIOM prediction model
Arm group label: Development and Validation of severe RIOM prediction model

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.

Criteria for eligibility:

Study pop:
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

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Yu Zeng

Address:
City: Guangzhou
Zip: 510000
Country: China

Status: Recruiting

Contact:
Last name: Yu Zeng, Dr.

Phone: +862066673666
Email: apple02180717@126.com

Start date: September 22, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class: Other

Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05858385