Status:
RECRUITING
Topical Diclofenac for Prevention of Radiation-induced Dermatitis
Lead Sponsor:
The Second Affiliated Hospital of Hainan Medical University
Conditions:
Head and Neck Tumor
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
Radiation induced dermatitis (RID) is one of the most commonly reported adverse events of Head and neck tumor, breast cancer radiation therapy (RT). Radiation therapy toxicity is exhibited within hour...
Eligibility Criteria
Inclusion
- 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
- The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB ≥ 100g/L, b. WBC ≥3×10\^9/L c. ANC≥1.5×10\^9/L, d. PLT ≥100×10\^9/L; (2) Biochemical examination must meet the following standards: a. BIL\<1.5 times the upper limit of normal value (ULN), b. ALT and AST\<2.5ULN, GPT ≤1.5×ULN; c. Serum Cr≤1 ULN, endogenous creatinine clearance rate\>60ml/min (Cockcroft Gault formula);(3).Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;(4).The myocardial enzyme spectra were in the normal range.
- Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.
Exclusion
- 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.
- Systemic diseases known to delay the skin healing process, such as diabetes or severe kidney failure;
- Skin rupture caused by malignant tumors.
Key Trial Info
Start Date :
February 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06905561
Start Date
February 13 2025
End Date
December 31 2026
Last Update
June 6 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570311