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

March 12, 2024 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

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 radiotherapy, and has a significant impact on patients' quality of life and treatment outcomes. Radiation-induced oropharyngeal mucositis is closely related to the irradiated dose and volume, and the performance of the predictive models for its occurrence and severity established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory. Thus, it is difficult to carry out risk assessment, precise screening and early intervention through dosimetric parameters, thereby reducing the occurrence of severe radiation-induced oropharyngeal mucositis. The investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced NPC, and our preliminary results demonstrated that the predictive model exhibited better overall performance. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

Study Type

Observational

Enrollment (Estimated)

718

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
          • Yimin Liu
      • Guangzhou, Guangdong, China
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Yong Bao
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Linglong Tang
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
        • Contact:
          • Ronghui Zheng
      • Shaoguan, Guangdong, China
        • Not yet recruiting
        • Yuebei People's Hospital
        • Contact:
          • Suming Pan
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Min Chen
      • Zhuhai, Guangdong, China
        • Not yet recruiting
        • The Fifth Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Siyang Wang
    • Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Xueguan lv
    • Sichuan
      • Chendu, Sichuan, China
        • Not yet recruiting
        • Sichuan Cancer hospital
        • Contact:
          • Wenjun Liao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The AUC of the predictive model
Time Frame: Through study completion, up to 3 years
The area under the ROC (receiver operating characteristic) curve (AUC) of the predictive model
Through study completion, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The important predictors of severe oropharyngeal mucositis in the predictive model
Time Frame: Through study completion, up to 3 years
The importance of variables included in the predictive model was measure, and those with a higher value indicating a greater contribution to the model's classification accuracy were viewed as the important predictors.
Through study completion, up to 3 years
The accuracy of the predictive model
Time Frame: Through study completion, up to 3 years

To obtained this index, true positive (TP) and true negative (TN) were calculated from the confusion matrix.

Accuracy = (TP+TN)/(Σ Total population)
Through study completion, up to 3 years
The sensitivity of the predictive model
Time Frame: Through study completion, up to 3 years

To obtained this index, true positive (TP) and false negative (FN) were calculated from the confusion matrix.

Sensitivity = TP/(TP + FN)
Through study completion, up to 3 years
The specificity of the predictive model
Time Frame: Through study completion, up to 3 years

To obtained this index, false positive (FP) and true negative (TN) were calculated from the confusion matrix.

Specificity = TN/(TN + FP)
Through study completion, up to 3 years
The positive predictive value of the predictive model
Time Frame: Through study completion, up to 3 years

To obtained this index, true positive (TP) and false positive (FP) were calculated from the confusion matrix.

Positive Predictive value (PPV) = TP/(TP + FP)
Through study completion, up to 3 years
The negative predictive value of the predictive model
Time Frame: Through study completion, up to 3 years

To obtained this index, true negative (TN) and false negative (FN) were calculated from the confusion matrix.

Negative Predictive value (NPV) = TN/(TN + FN)
Through study completion, up to 3 years
The F1 score of the predictive model
Time Frame: Through study completion, up to 3 years

To obtained this index, true positive (TP), false positive (FP), and false negative (FN) were calculated from the confusion matrix.

F1 score = 2TP/(2TP + FP + FN)
Through study completion, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Jian Guan, Ph.D., Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2024-090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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