Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
Conditions
Keywords
Nasopharyngeal carcinoma, Radiotherapy, Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain, Delineation method
Brief 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.
Detailed description
Swallowing-induced breakthrough pain as a prominent clinical challenge for radiation-induced oropharyngeal mucositis, occurs in almost all patients with nasopharyngeal carcinoma (NPC) undergoing radiotherapy, and has a significant impact on patients' quality of life and treatment outcomes. Radiation-induced oropharyngeal mucositis is closely related to the irradiated dose and volume, and the performance of the predictive models for its occurrence and severity established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory. Thus, it is difficult to carry out risk assessment, precise screening and early intervention through dosimetric parameters, thereby reducing the occurrence of severe radiation-induced oropharyngeal mucositis. The investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced NPC, and our preliminary results demonstrated that the predictive model exhibited better overall performance. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.
Interventions
None listed
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The AUC of the predictive model | Through study completion, up to 3 years | The area under the ROC (receiver operating characteristic) curve (AUC) of the predictive model |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity of the predictive model | Through study completion, up to 3 years | To obtained this index, true positive (TP) and false negative (FN) were calculated from the confusion matrix. Sensitivity = TP/(TP + FN) |
| The specificity of the predictive model | Through study completion, up to 3 years | To obtained this index, false positive (FP) and true negative (TN) were calculated from the confusion matrix. Specificity = TN/(TN + FP) |
| The positive predictive value of the predictive model | Through study completion, up to 3 years | To obtained this index, true positive (TP) and false positive (FP) were calculated from the confusion matrix. Positive Predictive value (PPV) = TP/(TP + FP) |
| The accuracy of the predictive model | Through study completion, up to 3 years | To obtained this index, true positive (TP) and true negative (TN) were calculated from the confusion matrix. Accuracy = (TP+TN)/(Σ Total population) |
| The F1 score of the predictive model | Through study completion, up to 3 years | To obtained this index, true positive (TP), false positive (FP), and false negative (FN) were calculated from the confusion matrix. F1 score = 2TP/(2TP + FP + FN) |
| The important predictors of severe oropharyngeal mucositis in the predictive model | Through study completion, up to 3 years | The importance of variables included in the predictive model was measure, and those with a higher value indicating a greater contribution to the model's classification accuracy were viewed as the important predictors. |
| The negative predictive value of the predictive model | Through study completion, up to 3 years | To obtained this index, true negative (TN) and false negative (FN) were calculated from the confusion matrix. Negative Predictive value (NPV) = TN/(TN + FN) |
Countries
China
Contacts
Primary ContactJian Guan, Ph.D.
Outcome results
None listed