CClinicalTrials.gg
RecruitingNCT07559877Updated Apr 30, 2026

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

A Phase 3 interventional study of 2% chlorhexidine and Sterile Water as control in Nasopharangeal Cancer, sponsored by Jiangxi Provincial Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Jiangxi Provincial Cancer Hospital · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study investigated the effects of topical chlorhexidine spray on the incidence, severity, and quality of life during radiotherapy in nasopharyngeal carcinoma patients.

02

Conditions studied

  • Nasopharangeal Cancer

Keywords

  • Radiation Dermatitis Acute
  • Nasoharyngeal carcinoma
  • chlorhexidine
03

In context

Lead sponsor

Jiangxi Provincial Cancer Hospital is the lead sponsor of 33 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    Experimental intervention

    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

  • Placebo comparator
    Control intervention

    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

  • Drug2% chlorhexidine

    Topical 2% chlorhexidine spray

  • DrugSterile Water as control

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

06

What researchers measure

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

    Time frame: Proportion of participants who develop CTCAE v5.0 grade 2-MD or higher grade 2 ARD during radiotherapy through 1 week after radiotherapy

07

Study locations

1 of 1 sites recruiting
  • Jiangxi Cancer Hospital
    Nanchang, Jiangxi 330029, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07559877
Lead sponsor
Jiangxi Provincial Cancer Hospital
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Apr 30, 2026

Study contacts

Tianzhu Lu, PhD
Contact
lutianzhu2008@163.com
+8615270186250

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion