NCT06308328 A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
| NCT ID | NCT06308328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Radiation-induced Oropharyngeal Mucositis |
| Study Type | OBSERVATIONAL |
| Enrollment | 718 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 718 participants in total. It began in 2024-04-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jian Guan, Ph.D.
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06308328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation-induced Oropharyngeal Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06308328 currently recruiting?
Yes, NCT06308328 is actively recruiting participants. Contact the research team at guanjian5461@163.com for enrollment information.
Where is the NCT06308328 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Guangzhou, China and 6 additional locations.
Who is sponsoring the NCT06308328 clinical trial?
NCT06308328 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Jian Guan, Ph.D. at Nanfang Hospital, Southern Medical University. The trial plans to enroll 718 participants.