Oral health education to prevent complications from head and neck cancer radiotherapy
A Single-center, Phase II Clinical Trial of Systematic Oral Education for the Prevention of Oral-related Complications Caused by Radiotherapy for Head and Neck Malignant Tumors
This study tests if a new way of teaching oral health can help people with head and neck cancer avoid problems while they are getting radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06690346 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of systematic oral health education in preventing oral-related complications in patients with malignant tumors of the head and neck undergoing radiotherapy. Participants will be divided into two groups: one receiving systematic oral health education and the other receiving routine oral health education. The study aims to evaluate and compare the outcomes of both educational approaches to determine if systematic education leads to better prevention of complications. The trial will include patients aged 18 to 80 who are receiving radiotherapy with a specific radiation dose.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with malignant head and neck tumors who are receiving radiotherapy.
Not a fit: Patients with a history of head and neck radiotherapy or those with severe oral hygiene issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce oral complications for patients undergoing radiotherapy for head and neck cancer.
How similar studies have performed: Similar studies have shown promise in improving patient outcomes through educational interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with malignant tumors of the head and neck without metastasis * Age ≥18, ≤80 years old * ZPS score ≤2 * Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of \>50 Gy * Signed informed consent form Exclusion Criteria: * Patients with oral mucositis due to allergic reactions to certain foods, medications, or oral care products * Have a history of head and neck radiotherapy * Poor oral hygiene or severe periodontitis * Poor compliance * Other patients who, in the opinion of the investigator, are not suitable for participation in this study
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Xingchen Peng
- Email: pxx2014@scu.edu.cn
- Phone: +8618980606753
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.