Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Incidence of severe RIOM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of severe RIOM
时间窗: during radiotherapy
According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM
次要结局
- Risk factors of severe RIOM(baseline (before radiotherapy))