Clinical trial NCT06308328: A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation-induced Oropharyngeal Mucositis
Swallowing-induced Breakthrough Pain
Keywords: Nasopharyngeal carcinoma
Radiotherapy
Radiation-induced Oropharyngeal Mucositis
Swallowing-induced Breakthrough Pain
Delineation method
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 718
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 receiving radical radiotherapy or chemoradiotherapy

Brief summary: 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.

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.

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 of the predictive model
timeFrame: Through study completion, up to 3 years
measure: The sensitivity of the predictive model
timeFrame: Through study completion, up to 3 years
measure: The specificity of the predictive model
timeFrame: Through study completion, up to 3 years
measure: The positive predictive value of the predictive model
timeFrame: Through study completion, up to 3 years
measure: The negative predictive value of the predictive model
timeFrame: Through study completion, up to 3 years
measure: The 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: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang hospital, Southern medical university
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chendu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jian Guan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: