Chlorhexidine spray to prevent radiation skin damage during nasopharyngeal cancer treatment
Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma: A Phase III Randomized Double-Blind Single-Center Trial
This trial will test whether applying a 2% chlorhexidine spray during chemoradiotherapy reduces skin irritation and improves quality of life for people with stage II–III nasopharyngeal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jiangxi Provincial Cancer Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT07559877 on ClinicalTrials.gov |
What this trial studies
This Phase 3 randomized interventional trial compares topical 2% chlorhexidine spray versus sterile water applied to the head and neck skin during definitive chemoradiotherapy for stage II–III nasopharyngeal carcinoma with N≥1. Patients receive standard radiotherapy (60–70 Gy) with concurrent chemotherapy and are followed for incidence and severity of acute radiation dermatitis and patient-reported quality of life. Key eligibility includes histologically confirmed disease, planned first-course definitive chemoradiotherapy, ability to consent, and no prior prophylactic skin interventions or known chlorhexidine allergy. The trial is conducted at Jiangxi Cancer Hospital with regular on-treatment skin assessments using standardized grading.
Who should consider this trial
Good fit: Adults with histologically confirmed stage II–III nasopharyngeal carcinoma (N≥1) scheduled for first-course definitive chemoradiotherapy to 60–70 Gy, able to provide consent, and without known chlorhexidine allergy are ideal candidates.
Not a fit: Patients with pre-existing skin disease, known hypersensitivity to chlorhexidine, other active malignancies, prior prophylactic interventions for radiation dermatitis, or inability to complete planned chemoradiotherapy may not receive benefit.
Why it matters
Potential benefit: If successful, chlorhexidine spray could reduce how often and how severely patients develop radiation skin reactions and make treatment more comfortable.
How similar studies have performed: Topical antiseptics and barrier treatments have produced mixed results in smaller studies, and the use of chlorhexidine spray specifically for radiation dermatitis is relatively novel with limited large-scale evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Histologically or cytologically confirmed nasopharyngeal carcinoma. Clinical stage II-III disease with N≥1, according to the UICC/AJCC 9th edition. Planned to receive first-course definitive chemoradiotherapy, with a total radiotherapy dose of 60-70 Gy. Able to communicate and complete study assessments. Willing to participate and able to provide written informed consent. Eligible based on baseline assessments performed before chemoradiotherapy. Exclusion Criteria: * History of or current psychiatric disorder, cognitive impairment, or other severe organic disease. Presence of another concomitant malignancy. Receipt of any other prophylactic intervention for radiation dermatitis. Pre-existing skin disease before chemoradiotherapy. Known hypersensitivity or allergy to chlorhexidine.
Where this trial is running
Nanchang, Jiangxi
- Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: Tianzhu Lu, PhD
- Email: lutianzhu2008@163.com
- Phone: +8615270186250
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.