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NCT Number: NCT07559877

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

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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Key information

Conditions

Nasopharangeal Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location status: Recruiting

Location contact

Tianzhu Lu, PhD

CONTACT

[email protected]

15270186250

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2% chlorhexidine

Drug

Topical 2% chlorhexidine spray

Sterile Water as control

Drug

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

Primary outcomes

  1. Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis

    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

    Incidence of Grade 2 acute radiation dermatitis with moist desquamation (grade 2-MD) or higher acute radiation dermatitis based CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Tianzhu Lu, PhD

CONTACT

[email protected]

+8615270186250

Sponsors and collaborators

Lead sponsor

Jiangxi Provincial Cancer Hospital

Other

Registry information

Official study title

Topical Chlorhexidine Spray for the Prevention of Acute Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma: A Phase III Randomized Double-Blind Single-Center Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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