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This study investigated the effects of topical chlorhexidine spray on the incidence, severity, and quality of life during radiotherapy in nasopharyngeal carcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental intervention | Experimental | 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. |
|
| Control intervention | Placebo Comparator | Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% chlorhexidine | Drug | Topical 2% chlorhexidine spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis | Incidence of Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis based CTCAE v5.0 | Proportion of participants who develop CTCAE v5.0 grade 2-MD or higher grade 2 ARD during radiotherapy through 1 week after radiotherapy |
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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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianzhu Lu, PhD | Contact | +8615270186250 | lutianzhu2008@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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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.
| Sterile Water as control |
| Drug |
Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education. |
|