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

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.

Topical Use of Recombinant Human Epidermal Growth Factor (EGF)-Based Cream to Prevent Radiation Dermatitis in Breast Cancer Patients: a Single-Blind Randomized Preliminary Study

“…Numerous studies using different compounds such as corticosteroid, aloe vera, hyaluronic acid, sucralfate, biafine, moisturizing durable barrier cream, ascorbic acid, silver sulfadiazine, and calendula have been performed to identify a topical agent that prevents or minimizes the acute radiation dermatitis, but the results of most studies were negative or contradictory (Halperin et al, 1993, Williams et al, 1996, Fisher et al, 2000, Bostrom et al, 2001, Schmuth et al, 2002, Pommier et al, 2004, Merchant et al, 2007, Kirova et al, 2011, Hemati et al, 2012, Pinnix et al, 2012, Graham et al, 2013. A few topical agents demonstrated a superior efficacy in preventing acute radiation dermatitis in randomized phase Ⅲ trials (Schmuth et al, 2002, Pommier et al, 2004, however, there is no general agreement on the gold-standard approach for prevention or minimization of acute radiation dermatitis, and clinical practice seems to be varied across countries and institutions.…”

Plant Polyphenols and Tumors: From Mechanisms to Therapies, Prevention, and Protection Against Toxicity of Anti-Cancer Treatments

“…Unfortunately all these trials demonstrated that the treatment with Aloe vera gel possesses a very limited efficacy in the prevention of the toxic effects due to radiotherapy [289,290,291,292]. The current body of evidence leaves clinicians unable to provide comprehensive guidelines for prevention and management of acute radiation dermatitis.…”

Evaluation of clinical effectiveness of Aloe vera – a review

“…APP cream and Aloe vera gel which were symmetrically applied within the irradiated field after each treatment. Unfortunately, the results of these studies showed that the anionic phospholipid-based cream was significantly more effective than Aloe vera gel in the prevention and treatment of radiation-induced dermatitis [42].…”