RecruitingNCT06308328

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

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

718 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

Locations(10)

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China

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

Sichuan Cancer Hospital

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06308328


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