Observational study on a new method for managing radiation-induced mouth sores in cancer patients
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
This study is testing a new method to see if it can help predict and manage mouth sores in cancer patients receiving radiation treatment for nasopharyngeal carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 718 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 10 sites (Guangzhou, Guangdong and 9 other locations) |
| Trial ID | NCT06308328 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed nasopharyngeal carcinoma currently undergoing radical radiotherapy or chemoradiotherapy.
Not a fit: Patients with poor oral hygiene, untreated dental diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for patients suffering from radiation-induced oropharyngeal mucositis, improving their quality of life and treatment outcomes.
How similar studies have performed: While similar studies have explored predictive models for radiation-induced mucositis, this specific mucosal contouring method is novel and has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong and 9 other locations
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Nanfang hospital, Southern medical university — Guangzhou, Guangdong, China (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)
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- The Fifth Affiliated Hospital, Sun Yat-sen University — Zhuhai, Guangdong, China (Not_yet_recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Sichuan Cancer Hospital — Chengdu, Sichuan, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.