title: Three-Arm Randomized Phase III Trial: Quality Aloe and Placebo Cream Versus Powder as Skin Treatment During Breast Cancer Radiation Therapy.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: KADA Consulting, Edmonton, AB, Canada.
authors.forename: Donna
authors.initials: D
authors.lastname: Hoopfer
authors.affiliation: BC Cancer Agency Vancouver Island Centre, Victoria, BC, Canada.
authors.forename: Caroline
authors.initials: C
authors.lastname: Holloway
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Gabos
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Maha
authors.initials: M
authors.lastname: Alidrisi
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Susan
authors.initials: S
authors.lastname: Chafe
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Barbara
authors.initials: B
authors.lastname: Krause
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Alan
authors.initials: A
authors.lastname: Lees
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Nirmal
authors.initials: N
authors.lastname: Mehta
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Keith
authors.initials: K
authors.lastname: Tankel
authors.affiliation: University of Texas MD Anderson Cancer Center, Houston, TX, and Henry Ford Health Science Center, Henry Ford Hospital, Detroit, MI.
authors.forename: Faith
authors.initials: F
authors.lastname: Strickland
authors.affiliation: Division of Population Health and Information, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Hanson
authors.affiliation: Division of Population Health and Information, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Charlotte
authors.initials: C
authors.lastname: King
authors.affiliation: Department of Medical Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Sunita
authors.initials: S
authors.lastname: Ghosh
authors.affiliation: Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada. Electronic address: diane.severin@albertahealthservices.ca.
authors.forename: Diane
authors.initials: D
authors.lastname: Severin
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000504:Aloe; D001943:Breast Neoplasms / Q000532:radiotherapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage*; D011208:Powders / Q000008:administration & dosage*; D011855:Radiodermatitis / Q000175:diagnosis / Q000517:prevention & control*; D063465:Skin Cream / Q000008:administration & dosage
chemical_list: D010936:Plant Extracts; D011208:Powders
keywords: Aloe vera; Catterall skin scoring profile; Prevention; Radiotherapy; Skin reactions