Status:
RECRUITING
A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Radiation-induced Oropharyngeal Mucositis
Swallowing-induced Breakthrough Pain
Eligibility:
All Genders
18+ years
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 unsat...
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 radio...
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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT06308328
Start Date
April 1 2024
End Date
January 31 2027
Last Update
March 13 2024
Active Locations (10)
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1
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
2
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, China
3
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China