A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients

一项III期临床试验比较了基于阴离子磷脂的乳膏和基于芦荟的凝胶在预防儿童放射性皮炎方面的疗效

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Abstract

PURPOSE: Radiation dermatitis is a common side effect of radiation therapy (RT). In severe cases, RT must be interrupted until the skin heals, which can compromise treatment. The purpose of the study was to compare an anionic polar phospholipid (APP)-based cream and an aloe vera-based gel to determine their effectiveness in preventing and treating radiation dermatitis. PATIENTS AND METHODS: Forty-five pediatric patients (median age, 11 years) with various diagnoses who received at least 23.4 Gy participated. APP cream and aloe vera gel were symmetrically applied within the irradiated field after each treatment. Three measures were collected before, during and after completion of treatment: subject's skin comfort, dermatologic assessment, and common toxicity criteria (CTC). RESULTS: Significant differences in specific variables favoring APP cream use were noted in some patients including skin comfort variables, dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), smooth (p = 0.012) and dermatologic variables, dryness (p = 0.013), erythema (p = 0.002) and peely (p = 0.008). Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing the first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream. CONCLUSION: APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.

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