Clinical trial · Observational
A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
A Real-world Observational Study of a Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Predicting Radiation-induced Oropharyngeal Mucositis in Patients With Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-induced Oropharyngeal Mucositis | — | UNRESOLVED | — |
| Swallowing-induced Breakthrough Pain | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The AUC of the predictive model
- timeFrame
- Through study completion, up to 3 years
- description
- The area under the ROC (receiver operating characteristic) curve (AUC) of the predictive model
Secondary outcomes (7)
- measure
- The accuracy of the predictive model
- timeFrame
- Through study completion, up to 3 years
- description
- To obtained this index, true positive (TP) and true negative (TN) were calculated from the confusion matrix. Accuracy = (TP+TN)/(Σ Total population)
- measure
- The sensitivity of the predictive model
- timeFrame
- Through study completion, up to 3 years
- description
- To obtained this index, true positive (TP) and false negative (FN) were calculated from the confusion matrix. Sensitivity = TP/(TP + FN)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available