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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Diclofenac Sodium Gel
DrugDiclofenac 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.
Placebo gel
Other interventionThe placebo does not contain the active ingredients of Jalosome, only the co-formulants.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Treatment group（diclofenac sodium gel ）Experimental treatment 1 intervention
Group B: control group（Placebo Comparator）Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of development of grade ≥ 2 RID
If the patient developed grade ≥ 2 RID or not, RTOG standards were used for evaluation
Time frame
From the first day of radiotherapy until 2 weeks after the end of radiotherapySecondary outcomes
1
Evaluation of Time to develop grade ≥2 RID
EvaluationTime to develop grade ≥ 2 RID incidence, will be assessed by RTOG criteria based on the clinical presentation of Time to develop grade ≥2 RID
Time frame
From the first day of radiotherapy until 2 weeks after the end of radiotherapy2
Evaluation of Pain Intensity
Pain related assessment will be done through a Visual Analog Scale, with 0 being No pain and 10 being unbearable pain
Time frame
From the first day of radiotherapy until 2 weeks after the end of radiotherapy3
Evaluation of Incidence of Treatment-Emergent Adverse Events
Patients will be educated and instructed to report any adverse events
Time frame
From the first day of radiotherapy through treatment completion(up to 7 weeks or 5 weeks)4
Evaluation of Quality of life
Skin-related quality of life assessed through the Dermatology Life Quality Index (DLQI)
Time frame
From the first day of radiotherapy until 2 weeks after the end of radiotherapySponsors and contacts
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Source ClinicalTrials.gov