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• W4233392905 abstract "Acute radiation dermatitis is associated with an inflammatory cascade that is thought to be cytokine mediated, although the exact mechanisms remain unclear. Animal studies indicate that topical emu oil has anti-inflammatory properties in the CD-1 mouse that are associated with cytokines and TNF-α. Emu oil is also associated with improved healing in patients with thermal burns. The purpose of this pilot study was to evaluate the feasibility of mounting a larger study to examine the effect of an enhanced Ultra Emu Oil on skin-related toxicity patients undergoing radiation therapy (RT) to the breast or chest wall. Patients were randomized 2:1 in a double-blind fashion and instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily on each treatment day during the course of radiation therapy at least five weeks in duration. 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 (NCI CTCAE 3.0), the Skin Toxicity Assessment Tool (STAT), quality of life (QOL) measured by Linear Analogue Self Assessment (LASA) and a Symptom Experience Diary (SED). A pilot sample size of 45 was used to test clinical logistics and obtain preliminary effect size estimates for design of a larger follow-up study. Statistical significance was not used as a criterion for assessment. Forty-two of 45 patients completed the study and were evaluable for analysis. Peak time to rash, skin redness, peeling, skin swelling was week 6, 6, 7, and 7, respectively as measured by the SED. Skindex AUC scores tended to be lower in emu oil than placebo patients, mean total AUC 7.2 vs. 10.4, respectively. This trend was also seen in all the Skindex sub-domains. 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 on emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. One grade 3 CTC event was documented on the emu oil arm in a post-mastectomy patient. There appeared to be no differences in adverse events between the emu oil and cottonseed oil as measured by the SED or the STAT. This pilot study demonstrates that patients can successfully be recruited and complete a double-blind, placebo-controlled study of emu oil's impact on radiation dermatitis. The moderate effect sizes observed indicated that emu oil was associated with slightly improved Skindex AUC scores compared to placebo in patients receiving RT for breast cancer with no significant increase in toxicity. No adverse events were noted in either arm. Further study of Ultra Emu Oil© is warranted to confirm these results." @default.
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• W4233392905 date "2012-11-01" @default.
• W4233392905 modified "2023-09-27" @default.
• W4233392905 title "Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis" @default.
• W4233392905 doi "https://doi.org/10.1016/j.ijrobp.2012.07.1720" @default.
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