Topical Diclofenac for Prevention of Radiation-induced Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Second Affiliated Hospital of Hainan Medical University
About this trial
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 criteria
Qualifiers
Male and female which are 18 years of age or older
Performance status < 2
Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
The RTOG radiation dermatitis rating should be equal to 0 and the skin nutrition should be good
Disqualifiers
Pregnant or lactating women
A known history of intolerance or allergy to any component of the investigational product;
severe cardiopulmonary disease (such as unstable angina attacks, grade II cardiac insufficiency, acute myocardial infarction, acute episodes of chronic obstructive pulmonary disease, pulmonary heart disease);
The acute phase is accompanied by inflammatory skin diseases, such as atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea.
Trial design
Treatments tested in this trial
- Diclofenac Sodium Gel
- Placebo gel
Treatment groups
156 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov