Nasopharyngeal Carcinoma by AJCC V8 Stage, Radiation Induced Mucositis
Conditions
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.
Interventions
Intervention based on key factors identified by the severe RIOM prediction model
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe RIOM | during radiotherapy | According to the CTCAE V5.0 ,Grade 3 and Grade 4 is considered severe RTOM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors of severe RIOM | baseline (before radiotherapy) | Patient factors, disease factors, and treatment related factors |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes from oral dryness in RIOM patients | Baseline, the 10th, 20th and 30th days of radiotherapy | 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. |
| Changes from salivary PH compared to baseline in RIOM patients | Baseline, the 10th, 20th and 30th days of radiotherapy | Evaluation of salivary PH using pH indicator paper |
| Changes from the pain in xerostomia combined with RIOM patients | Baseline, the 10th, 20th and 30th days of radiotherapy | 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. |
Countries
China