Predicting oral mucositis in nasopharyngeal cancer patients undergoing radiation therapy
Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma
This study is trying to find out which factors can help predict severe mouth sores in patients with nasopharyngeal cancer who are getting radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Cancer Hospital & Institute of Guangzhou Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05858385 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on developing predictive models for severe Radiation-Induced Oral Mucositis (RIOM) in patients with locally advanced nasopharyngeal carcinoma receiving radiotherapy. By analyzing various dosimetric, clinical, and oral factors, the study aims to identify key risk factors that contribute to severe RIOM. The research seeks to enhance the ability of healthcare providers to predict and manage this condition, ultimately improving patient outcomes during treatment. The study employs a novel fusion classifier to maximize the use of information from different sources to create a reliable risk prediction model.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with nasopharyngeal carcinoma at AJCC 8th edition stages I to Iva, who are receiving their first course of radical radiation therapy.
Not a fit: Patients with oral mucosal diseases that are not well-controlled or those with other conditions affecting oral inflammation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of severe oral mucositis in nasopharyngeal carcinoma patients, improving their quality of life and treatment adherence.
How similar studies have performed: While there have been studies on oral mucositis in cancer patients, this specific predictive approach using a fusion classifier is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Yu Zeng — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.