Three-Arm Randomized Phase III Trial: Quality Aloe and Placebo Cream Versus Powder as Skin Treatment During Breast Cancer Radiation Therapy

Clin Breast Cancer. 2015 Jun;15(3):181-90.e1-4. doi: 10.1016/j.clbc.2014.12.006. Epub 2014 Dec 24.


Background: The efficacy of aloe extract in reducing radiation-induced skin injury is controversial. The purpose of the present 3-arm randomized trial was to test the efficacy of quality-tested aloe extract in reducing the severity of radiation-induced skin injury and, secondarily, to examine the effect of a moist cream versus a dry powder skin care regimen.

Materials and methods: A total of 248 patients with breast cancer were randomized to powder, aloe cream, or placebo cream. Acute skin toxicity was scored weekly and after treatment at weeks 1, 2, and 4 using a modified 10-point Catterall scale. The patients scored their symptom severity using a 6-point Likert scale and kept an acute phase diary.

Results: The aloe formulation did not reduce acute skin toxicity or symptom severity. Patients with a greater body mass index were more likely to develop acute skin toxicity. A similar pattern of increased skin reaction toxicity occurred with both study creams compared with the dry powder regimen.

Conclusion: No evidence was found to support prophylactic application of quality aloe extract or cream to improve the symptoms or reduce the skin reaction severity. Our results support a dry skin care regimen of powder during radiation therapy.

Keywords: Aloe vera; Catterall skin scoring profile; Prevention; Radiotherapy; Skin reactions.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Aloe*
  • Breast Neoplasms / radiotherapy*
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Phytotherapy*
  • Plant Extracts / administration & dosage*
  • Powders / administration & dosage*
  • Radiodermatitis / diagnosis
  • Radiodermatitis / prevention & control*
  • Skin Cream / administration & dosage


  • Plant Extracts
  • Powders