Clinical trial NCT05858385: Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
Official title: Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
Radiation Induced Mucositis
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Incidence of severe RIOM
timeFrame: during radiotherapy
Secondary outcomes:
measure: Risk factors of severe RIOM
timeFrame: baseline (before radiotherapy)
Other outcomes:
measure: Changes from oral dryness in RIOM patients
timeFrame: Baseline, the 10th, 20th and 30th days of radiotherapy
measure: Changes from salivary PH compared to baseline in RIOM patients
timeFrame: Baseline, the 10th, 20th and 30th days of radiotherapy
measure: Changes from the pain in xerostomia combined with RIOM patients
timeFrame: Baseline, the 10th, 20th and 30th days of radiotherapy
Locations:
city: Guangzhou
country: China
facility: Yu Zeng
state: Guangdong
Study officials:
References: