Observational study on a new method for managing radiation-induced mouth sores in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a mucosal contouring method for predicting the occurrence and severity of radiation-induced oropharyngeal mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy. The study will assess how well this new method can identify patients at risk of severe mucositis and swallowing-induced breakthrough pain, which significantly affects their quality of life. By utilizing a multicenter approach, the study seeks to gather real-world data to improve risk assessment and early intervention strategies for this condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanfang hospital, Southern medical university
  Guangzhou, Guangdong, China Recruiting
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  Guangzhou, Guangdong, China Not yet recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting
• The First Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Not yet recruiting
• Yuebei People's Hospital
  Shaoguan, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Jian Guan, Ph.D. — Nanfang Hospital, Southern Medical University
• Study coordinator: Jian Guan, Ph.D.
• Email: guanjian5461@163.com
• Phone: +86-13632102247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.