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NCT Number: NCT06308328

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

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.

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Key information

Conditions

Radiation-induced Oropharyngeal Mucositis Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Swallowing-induced Breakthrough Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, Guangdong, China

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About this study

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.

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 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 13, 2024
Registry last updated
Mar 13, 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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