Actively Recruiting

Age: 18Years +
All Genders
NCT06308328

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

Led by Nanfang Hospital, Southern Medical University · Updated on 2024-03-13

718

Participants Needed

10

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed written consent.
  • Age 18 years or older.
  • Histologically confirmed nasopharyngeal carcinoma.
  • Currently undergoing radical radiotherapy or chemoradiotherapy.
  • Complete and continuous records of oral or oropharyngeal mucositis grading and self-reported swallowing-induced breakthrough pain.
Not Eligible

You will not qualify if you...

  • Poor oral hygiene, untreated dental or periodontal diseases, or metal dental restorations.
  • Untreated or unresolved unstable heart diseases requiring treatment.
  • Poorly controlled diabetes mellitus.
  • Body mass index (BMI) less than 18.5.
  • Considered unsuitable for participation by researchers.

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

2

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China

Actively Recruiting

3

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Not Yet Recruiting

4

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Not Yet Recruiting

5

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Not Yet Recruiting

6

Yuebei People's Hospital

Shaoguan, Guangdong, China

Not Yet Recruiting

7

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Not Yet Recruiting

8

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, Guangdong, China

Not Yet Recruiting

9

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

10

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Not Yet Recruiting

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Research Team

J

Jian Guan, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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