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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangxi Provincial Cancer Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

History of or current psychiatric disorder, cognitive impairment, or other severe organic disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Experimental interventionExperimental treatment 1 intervention
Group B: Control interventionPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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