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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
• Intervention / Treatment: Other: Routine oral care

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Yu Zeng
      • Contact: Yu Zeng, Dr.; Phone Number: +862066673666; Email: apple02180717@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe RTOM; 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; 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.
Non Severe RTOM; 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; 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.

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from oral dryness in RTOM patients	According to the Clinical oral dryness score(CODS),A total of 10 features were used to obtain the total CODS. A high total score indicates increased oral dryness.	Baseline, the 10th, 20th and 30th days of radiotherapy
Changes from salivary PH compared to baseline in RTOM patients	Evaluation of salivary PH using pH indicator paper	Baseline, the 10th, 20th and 30th days of radiotherapy
Changes from the pain in xerostomia combined with RTOM patients	The evaluation of pain is based on the Numerical Rating Scale (NRS), with a numerical score of 0-10. A score of less than 5 is considered mild pain, a score of 5-7 is moderate pain, and a score of 8 or above is severe pain.	Baseline, the 10th, 20th and 30th days of radiotherapy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Estimated): June 30, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Mucositis; Stomatitis
• Other Study ID Numbers: oral mucositis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No