Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06905561

Topical Diclofenac for Prevention of Radiation-induced Dermatitis

Led by The Second Affiliated Hospital of Hainan Medical University · Updated on 2026-04-03

156

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. The Diclofenac is a COX-2 inhibitor and Nonsteroidal anti-inflammatory drugs whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Diclofenac sodium gel as a prophylactic method against the development of RID.

CONDITIONS

Official Title

Topical Diclofenac for Prevention of Radiation-induced Dermatitis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female aged 18 years or older
  • Performance status less than 2
  • Diagnosed with epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus, salivary glands, or breast cancer
  • Planned to receive at least 50 Gy total radiation dose
  • Radiation dermatitis rating of 0 and good skin nutrition at baseline
  • Normal functioning of main organs with blood and biochemical tests meeting specified thresholds
  • Willing and able to provide signed informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Known allergy or intolerance to any study product components
  • Severe heart or lung diseases such as unstable angina, significant heart failure, recent heart attack, or severe lung conditions
  • Active inflammatory skin diseases like atopic dermatitis, contact dermatitis, psoriasis, lichen planus, or pityriasis rosea
  • Systemic diseases that delay skin healing, such as diabetes or severe kidney failure
  • Skin damage caused by malignant tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China, 570311

Actively Recruiting

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Research Team

Y

yuecan zeng

CONTACT

J

junnv xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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