Nasopharangeal Cancer
Conditions
Keywords
Radiation Dermatitis Acute, Nasoharyngeal carcinoma, chlorhexidine
Brief summary
This study investigated the effects of topical chlorhexidine spray on the incidence, severity, and quality of life during radiotherapy in nasopharyngeal carcinoma patients.
Interventions
DRUG2% chlorhexidine
Topical 2% chlorhexidine spray
Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education.
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-blind. Participants, investigators, outcome assessors, and data entry staff will remain blinded to group allocation. Study sprays for the intervention and control groups will be identical in appearance, packaging, labeling, administration method, and dispensing procedure. Randomization codes will be kept by designated independent personnel and will not be broken until database lock, unless emergency unblinding is required for participant safety.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis | Proportion of participants who develop CTCAE v5.0 grade 2-MD or higher grade 2 ARD during radiotherapy through 1 week after radiotherapy | Incidence of Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis based CTCAE v5.0 |
Countries
China
Contacts
CONTACTTianzhu Lu, PhD
Outcome results
None listed