A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis

Recruiting now

Conditions studied: Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain

In brief

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.

Key facts

Study ID

NCT06308328

Run by

Nanfang Hospital, Southern Medical University

People needed

718

Starts

2024-04-01

Expected to finish

2027-01-31

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nanfang hospital, Southern medical university — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• Yuebei People's Hospital — Shaoguan, Guangdong, China
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China
• The Fifth Affiliated Hospital, Sun Yat-sen University — Zhuhai, Guangdong, China
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University — Guangzhou, Guangdong, China
• Sichuan Cancer Hospital — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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