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NCT Number: NCT06287788

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern Medical University

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Jian Guan, Ph.D.

CONTACT

[email protected]

86+13632102247

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Guan, Ph.D.

CONTACT

[email protected]

+86-13632102247

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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