Topical Diclofenac for Prevention of Radiation-induced Dermatitis

Korábbi kezelés

• A known history of intolerance or allergy to any component of the investigational product;

Más betegség

• 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.

Egyéb

• Pregnant or lactating women

• 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.