Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis.
OBJECTIVE
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
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.
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Denise C
DC
Rollmann
Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota.
Paul J
PJ
Novotny
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Ivy A
IA
Petersen
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Yolanda I
YI
Garces
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Heather J
HJ
Bauer
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Elizabeth S
ES
Yan
Department of General Internal Medicine, Mayo Clinic, Rochester, Minnesota.
Dietlind
D
Wahner-Roedler
Department of General Internal Medicine, Mayo Clinic, Rochester, Minnesota.
Ann
A
Vincent
Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota.
Jeff A
JA
Sloan
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota. Electronic address: laack.nadia@mayo.edu.
Nadia N
NN
Issa Laack
D000279:Administration, Cutaneous; D000328:Adult; D019540:Area Under Curve; D001940:Breast / Q000528:radiation effects; D001943:Breast Neoplasms / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000532:radiotherapy; D003369:Cottonseed Oil / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004890:Erythema / Q000209:etiology; D005076:Exanthema / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D009821:Oils / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D011788:Quality of Life; D011837:Radiation-Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011855:Radiodermatitis / Q000473:pathology / Q000517:prevention & control*; D018709:Statistics, Nonparametric; D035441:Thoracic Wall / Q000528:radiation effects
D003369:Cottonseed Oil; D009821:Oils; D011837:Radiation-Protective Agents; C575034:emu Oil