Rollmann, D.C., Novotny, P.J., Petersen, I.A., Garces, Y.I., Bauer, H.J., Yan, E.S., . . . Issa Laack, N.N. (2015). Double-blind, placebo-controlled pilot study of processed ultra emu oil versus placebo in the prevention of radiation dermatitis. International Journal of Radiation Oncology, Biology, Physics, 92, 650–658. 

DOI Link

Study Purpose

To evaluate the effects of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy (RT) to the breast or chest wall

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either the emu oil or a cotton seed oil placebo. Patients were instructed to apply the oil two times per day during radiation treatment and for six weeks after completion. The oil was to be applied at least four hours before treatment to avoid any bolus effect. No other creams or oils were to be used. Any additional treatments were to be documented by providers. Patients were assessed at baseline, weekly during treatment, and six weeks later.

Sample Characteristics

  • N = 42  
  • AGE = 18 years or older
  • MALES (%): Not specified, FEMALES (%): Not specified
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer undergoing RT to the breast (breast conservation therapy) or the chest wall (postmastectomy RT)  
  • OTHER KEY SAMPLE CHARACTERISTICS: Primary invasive breast carcinoma or ductal carcinoma in situ. The daily treatment dose was between 1.75 Gy and 2.12 Gy. Patients could enter the study before receiving the third RT fraction. Of the patients, 64.7% had a planned total dose greater than 55 Gy, and 64.3% had prior chemotherapy.

Setting

  • SITE: Single site
  • SETTING TYPE: Outpatient
  • LOCATION: Rochester, MN

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Double-blind, randomized, placebo-controlled trial

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  • Skindex-16
  • Patient diary to record symptoms on 0–10 scale

Results

Patient symptoms reported varied between groups, with some symptoms more severe in the emu oil group and some more severe in the control group. No statistically significant differences in symptoms or skin toxicity scores existed between groups. For most of the study period, those using the emu oil had lower Skindex scores; however, by the end of the trial, their Skindex scores were higher. A higher proportion of those using emu oil had grade 2 and 3 CTCAE scores, although this difference was not statistically significant.

Conclusions

This study did not show any substantial benefit or adverse effects associated with the use of emu oil to prevent radiodermatitis.

Limitations

  • Small sample (< 100)
  • Unintended interventions or applicable interventions not described that would influence results
  • Providers could use additional supportive interventions, such as hydrocortisone cream, but no information on whether any patients had additional interventions was provided.

Nursing Implications

Radiation dermatitis is a common dermatologic adverse event, and management of this toxicity requires a wide range of treatment modalities. This study did not provide strong evidence for or against the use of emu oil. Further research is needed to determine efficacy and safety.