Rollmann Denise C, Novotny Paul J, Petersen Ivy A, Garces Yolanda I, Bauer Heather J, Yan Elizabeth S, Wahner-Roedler Dietlind, Vincent Ann, Sloan Jeff A, Issa Laack Nadia N
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota.
Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):650-8. doi: 10.1016/j.ijrobp.2015.02.028. Epub 2015 Apr 28.
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.
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).
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.
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.
本单机构试点研究的目的是评估一种油基皮肤制剂超鸸鹋油对接受乳房或胸壁放射治疗患者皮肤相关毒性的可行性和安全性。
患者以2:1的比例进行双盲随机分组，并被指示在放射治疗过程中每天两次涂抹经过处理的超鸸鹋油或安慰剂（棉籽油）。这些油在第三次分次放疗前涂抹，并在治疗完成后持续使用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）。次要结果包括使用不良事件通用术语标准（CTCAE 3.0）的放射性皮炎最高分级、皮肤毒性评估工具、通过线性模拟自我评估测量的生活质量（QOL）以及症状体验日记（SED）。
45名患者中共有42名完成了研究并可进行评估。根据SED测量，皮疹、皮肤发红、脱皮和皮肤肿胀达到峰值的中位时间分别为第6周、第6周、第7周和第7周。鸸鹋油组患者的Skindex AUC评分往往低于安慰剂组患者（平均总AUC分别为7.2和10.4）。在所有Skindex子领域中也观察到了这种趋势。鸸鹋油组的总体生活质量略好，但在整个研究过程中两组均保持稳定。CTCAE毒性峰值出现在第6周。使用鸸鹋油的患者在CTCAE最高分级上似乎略差，但差异不显著。
这项试点研究证实了放射治疗期间油基皮肤治疗的安全性，并表明接受鸸鹋油治疗的患者皮肤毒性有降低的趋势。需要进行更大规模的研究来评估鸸鹋油在减少接受乳房放疗患者放射性皮炎方面的疗效。
