A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Primary outcome measures
- The AUC of the predictive model [Time frame: Through study completion, up to 3 years]
Secondary outcome measures (7)
- The accuracy of the predictive model [Time frame: Through study completion, up to 3 years]
- The sensitivity of the predictive model [Time frame: Through study completion, up to 3 years]
- The specificity of the predictive model [Time frame: Through study completion, up to 3 years]
- The positive predictive value of the predictive model [Time frame: Through study completion, up to 3 years]
- The negative predictive value of the predictive model [Time frame: Through study completion, up to 3 years]
- The F1 score of the predictive model [Time frame: Through study completion, up to 3 years]
- The important predictors of severe oropharyngeal mucositis in the predictive model [Time frame: Through study completion, up to 3 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 10 centers
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University — Guangzhou
- Nanfang hospital, Southern medical university — Guangzhou
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
- Yuebei People's Hospital — Shaoguan
- Peking University Shenzhen Hospital — Shenzhen
- The Fifth Affiliated Hospital, Sun Yat-sen University — Zhuhai
- … and 2 more centers
Identifiers
NCT: NCT06308328 · NFEC-2024-090