Double-blind, placebo-controlled pilot study of processed ultra emu oil versus placebo in the prevention of radiation dermatitis

Denise C. Rollmann, Paul J. Novotny, Ivy A Petersen, Yolanda Isabel Garces, Heather J. Bauer, Elizabeth S. Yan, Dietlind Wahner-Roedler, Ann Vincent, Jeff A Sloan, Nadia N Laack

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)650-658
Number of pages9
JournalInternational Journal of Radiation Oncology Biology Physics
Volume92
Issue number3
DOIs
StatePublished - Jul 1 2015

Fingerprint

Radiodermatitis
dermatitis
oils
Placebos
radiation
Skin
Terminology
toxicity
Area Under Curve
terminology
Oils
Radiotherapy
radiation therapy
Breast
Quality of Life
breast
Cottonseed Oil
Safety
grade
safety

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research

Cite this

Double-blind, placebo-controlled pilot study of processed ultra emu oil versus placebo in the prevention of radiation dermatitis. / Rollmann, Denise C.; Novotny, Paul J.; Petersen, Ivy A; Garces, Yolanda Isabel; Bauer, Heather J.; Yan, Elizabeth S.; Wahner-Roedler, Dietlind; Vincent, Ann; Sloan, Jeff A; Laack, Nadia N.

In: International Journal of Radiation Oncology Biology Physics, Vol. 92, No. 3, 01.07.2015, p. 650-658.

Research output: Contribution to journalArticle

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abstract = "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.",
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AU - Petersen, Ivy A

AU - Garces, Yolanda Isabel

AU - Bauer, Heather J.

AU - Yan, Elizabeth S.

AU - Wahner-Roedler, Dietlind

AU - Vincent, Ann

AU - Sloan, Jeff A

AU - Laack, Nadia N

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