A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
- Conditions
- Radiation-induced Oropharyngeal MucositisSwallowing-induced Breakthrough Pain
- Registration Number
- NCT06308328
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 718
- Provide informed written consent.
- Age ≥ 18 years.
- Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
- Complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain.
- Existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations.
- Current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus.
- Body mass index (BMI) <18.5.
- Unsuitable to participate in current study, according to researchers' assessment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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)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.
Trial Locations
- Locations (10)
Yuebei People's Hospital
🇨🇳Shaoguan, Guangdong, China
The Fifth Affiliated Hospital, Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Nanfang hospital, Southern medical university
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Sichuan Cancer Hospital
🇨🇳Chendu, Sichuan, China