Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis
Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis
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DOI：
10.1016/j.ijrobp.2015.02.028
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发表时间：
2015-07-01
影响因子：
7
通讯作者：
Laack, Nadia N. Issa
中科院分区：
文献类型：
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作者：
Rollmann, Denise C.;Novotny, Paul J.;Laack, Nadia N. Issa
目的：这个单一的机构试点研究的目的是评估的可行性和安全性的油为基础的皮肤剂，超鸸鹋油，对皮肤相关的毒性在接受放射治疗的患者乳房或胸wall.Methods和材料：患者随机2：1在一个双盲的方式，并指示应用处理超鸸鹋油或安慰剂（棉籽油），每天两次在放射治疗的过程中。在第三部分之前施用油，并在治疗完成后持续6周。主要终点是Skindex-16量表评分随时间变化的曲线下面积（AUC）。次要结局包括使用不良事件通用术语标准（CTC）（CTCAE 3.0）、皮肤毒性评估工具、线性疼痛自我评估测量的生活质量（QOL）和症状体验日记（SED）的最高级别放射性皮炎。根据SED测量，达到皮疹、皮肤发红、脱皮和皮肤肿胀峰值的中位时间分别为第6、6、7和7周。鸸鹋油患者的Skindex AUC评分倾向于低于安慰剂患者（平均总AUC分别为7.2 vs 10.4）。这一趋势也出现在所有Skindex子域中。鸸鹋油组的总体生活质量略好，但在整个研究期间两组均保持稳定。CTC毒性峰值出现在第6周。使用鸸鹋油的患者出现轻微恶化的最大CTC等级，但差异并不显着。结论：这项试点研究证实了放射治疗过程中的安全性油为基础的皮肤治疗，并提出了减少皮肤毒性的患者接受鸸鹋油的趋势。需要进行更大规模的研究来评估鸸鹋油在减少接受乳腺放射治疗的患者的放射性皮炎方面的疗效。(C)2015 Elsevier Inc. All rights reserved.
Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall.Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED).Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant.Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation. (C) 2015 Elsevier Inc. All rights reserved.