RecruitingNot ApplicableNCT06905561

Topical Diclofenac for Prevention of Radiation-induced Dermatitis

Topical Diclofenac for Prevention of Radiation-induced Dermatitis: A Single-center, Randomized Controlled Trial


Sponsor

The Second Affiliated Hospital of Hainan Medical University

Enrollment

156 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether applying a topical diclofenac gel (an anti-inflammatory medicine) to the skin during radiation therapy can prevent or reduce radiation dermatitis — the painful, red, burned skin reaction that many cancer patients experience during radiation treatment. **You may be eligible if...** - You are 18 or older - You have head and neck cancer (oropharynx, nasopharynx, larynx, hypopharynx, or salivary glands) or breast cancer - You are planned to receive at least 50 Gy of radiation - Your skin in the treatment area is healthy with no current irritation - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have had prior radiation therapy that causes significant scarring or skin changes in the treatment area - You have a known allergy to diclofenac or NSAIDs - Your blood counts or organ function do not meet minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDiclofenac Sodium Gel

Diclofenac Sodium Gel were applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.

OTHERPlacebo gel

The placebo does not contain the active ingredients of Jalosome, only the co-formulants.


Locations(1)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

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NCT06905561


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