Clinical trial · Interventional
Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma:
Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma: A Phase III Randomized Double-Blind Single-Center Trial
NCT07559877CI-TRIAL-00109965recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investigated the effects of topical chlorhexidine spray on the incidence, severity, and quality of life during radiotherapy in nasopharyngeal carcinoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharangeal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2% chlorhexidine | Drug | — | UNRESOLVED |
| Sterile Water as control | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental intervention
- description
- Topical 2% chlorhexidine spray once daily after showering, sprayed evenly over the entire radiation field from a distance of 15-20 cm, starting 1 day before radiotherapy and continuing until 1 week after radiotherapy; stopped when grade ≥2 acute radiation dermatitis occurs. Standard skin care and health education will also be provided.
- interventionNames
- Drug: 2% chlorhexidine
- type
- PLACEBO_COMPARATOR
- label
- Control intervention
- description
- Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education.
- interventionNames
- Drug: Sterile Water as control
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.