A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Orop
The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallo
| Condition(s) | Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC. |
| Who can participate | Inclusion Criteria: 1. Provide informed written consent. 2. Age ≥ 18 years. 3. Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy. 4. Complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain. Exclusion Criteria: 1. Existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations. 2. Current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus. 3. Body mass index (BMI) \<18.5. 4. Unsuitable to participate in current study, according to researchers' assessment. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Nanfang Hospital, Southern Medical University |
| Locations | Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Shaoguan, Guangdong, China (+4 more sites) |
| Start date | 2024-04-01 |
| NCT ID | NCT06308328 |
| Official listing | https://clinicaltrials.gov/study/NCT06308328 |