A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis

February 23, 2024 updated by: Nanfang Hospital, Southern Medical University

The Prediction of a Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis in Patients With Nasopharyngeal Carcinoma: an Observational Study

The performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal 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. The aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Nasopharyngeal carcinoma (NPC) is particularly prevalent in southern China. Radiation-induced oropharyngeal mucositis is one of the most common acute toxicities in patients with NPC receiving radiotherapy. Swallowing-induced breakthrough pain is a prominent clinical challenge for radiation-induced oropharyngeal mucositis, which has a great impact on patients' quality of life and treatment outcomes. Nonetheless, no particularly effective therapeutic methods or medication are available currently, thus making timely and accurate prediction, identifying high-risk patients, and providing appropriate interventions are critical in reducing or delaying the occurrence of severe oropharyngeal mucositis. It has been found that the performance of the predictive models for severe oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in NPC. 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, 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)

240

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, 510515
        • Recruiting
        • Southern Medical University
        • Contact:

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 after 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 accuracy, sensitivity, specificity, positive predictive value, negative predictive value and F1 score of the predictive model
Time Frame: Through study completion, up to 3 years

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

Sensitivity = TP/(TP + FN) Specificity = TN/(TN + FP) Accuracy = (TP+TN)/(Σ Total population) Positive Predictive value (PPV) = TP/(TP + FP) Negative Predictive value (NPV) = TN/(TN + FN) F1 score = 2TP/(2TP + FP + FN)
Through study completion, up to 3 years
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

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)

March 1, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2024-068

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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