Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma:

NCT07559877 | Recruiting Phase 3

• 1 other identifier: CHANCE Trial
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharangeal Cancer

Keywords

Radiation Dermatitis Acute; Nasoharyngeal carcinoma; chlorhexidine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: 2% chlorhexidine

Control intervention

PLACEBO COMPARATOR

Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education.

Drug: Sterile Water as control

Interventions

2% chlorhexidine DRUG

Topical 2% chlorhexidine spray

Experimental intervention

Sterile Water as control DRUG

Topical sterile water spray with identical appearance and administration schedule, plus the same standard skin care and health education.

Control intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Tianzhu Lu, PhD

CONTACT

+8615270186250; lutianzhu2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)