A method to predict radiation-induced mouth sores in cancer patients
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
This study is testing a new way to predict if cancer patients receiving radiation for throat cancer will develop painful mouth sores, to help improve their treatment experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06287788 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a new mucosal contouring method based on swallowing-induced breakthrough pain to predict the occurrence of radiation-induced oropharyngeal mucositis in patients with nasopharyngeal carcinoma. The study will involve multiple centers and focus on patients undergoing radical radiotherapy or chemoradiotherapy. By identifying high-risk patients through this innovative predictive model, the study seeks to improve patient outcomes and quality of life. The researchers will analyze the effectiveness of this method compared to traditional contouring approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed nasopharyngeal carcinoma currently receiving 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 prediction and management of severe oropharyngeal mucositis, improving the quality of life for patients undergoing treatment for nasopharyngeal carcinoma.
How similar studies have performed: While traditional methods have shown limited success, this novel approach based on swallowing-induced pain has demonstrated better predictive performance in preliminary results.
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
- Southern Medical University — Guangzhou, Guangdong, China (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.