Oropharyngeal cancer
Conditions
Interventions
Standard oral stent group:Conventional oral stent (hollow mouthpiece, used as standard care in clinical practice)
Individualized oral stent:Using the silicone mold replication technology to fabricate individualized oral fillings for assisting radiotherapy
Sponsors
Jiangsu Provincial Hospital (The First Affiliated Hospital of Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed with oropharyngeal squamous cell carcinoma, and planned to undergo radical VMAT radiotherapy (+/- concurrent chemotherapy). 2. Aged between 18 and 75 years old, with a Karnofsky Performance Status (KPS) score of >= 70. 3. Capable of cooperating with oral impression taking and wearing the device. 4. Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous history of head and neck radiotherapy. 2. Active oral infection, uncontrolled oral infection or severe periodontal disease. 3. Severe mouth opening limitation (distance between incisors < 2.5 cm). 4. Other oral mucosal lesions that affect the assessment of mucositis. 5. Presence of cognitive or mental disorders that prevent cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade >=3 acute radiation-induced oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral mucosa V40;Degree of oral pain (Visual Analogue Scale);Standardized scores for the "Pain" and "Swallowing" domains in the EORTC QLQ-H&N35 scale; | — |
Countries
China
Contacts
Public ContactXu Xiaoyan
Jiangsu Provincial Hospital (The First Affiliated Hospital of Nanjing Medical University)
Outcome results
None listed