Clinical trial NCT06287788: A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation-induced Oropharyngeal Mucositis
Swallowing-induced Breakthrough Pain
Keywords: Nasopharyngeal carcinoma
Radiation
Oropharyngeal mucositis
Swallowing-induced breakthrough pain
Delineation method
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with nasopharyngeal carcinoma after receiving radical radiotherapy or chemoradiotherapy

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The AUC of the predictive model
timeFrame: Through study completion, up to 3 years
Secondary outcomes:
measure: The accuracy, sensitivity, specificity, positive predictive value, negative predictive value and F1 score of the predictive model
timeFrame: Through study completion, up to 3 years
measure: The important predictors of severe oropharyngeal mucositis in the predictive model
timeFrame: Through study completion, up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jian Guan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: