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:

  1. Provide informed written consent.
  2. Age ≥ 18 years.
  3. Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
  4. Complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain.

Exclusion Criteria:

  1. Existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations.
  2. Current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus.
  3. Body mass index (BMI) <18.5.
  4. 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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Page 1 of 3 (10 locations)

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