title: A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: trans Tasman Radiation Oncology Group (TROG) 04.01.
abstract: OBJECTIVE
  A previous, unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine cream (sorbolene). The different appearances of these products precluded a blinded comparison. To test the acrylate terpolymer principle in a double-blinded manner required the use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC); the study was conducted by the Trans Tasman Radiation Oncology Group (TROG) as protocol 04.01.
  
  
  METHODS
  A total of 333 patients were randomized; 1 patient was ineligible and 14 patients withdrew or had less than 7 weeks' observations, leaving 318 for analysis. The chest wall was divided into medial and lateral compartments, and patients were randomized to have MDBC applied daily to the medial or lateral compartment and sorbolene to the other compartment. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected to week 12 or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters.
  
  
  RESULTS
  Rates of medial and lateral compartment Common Toxicity Criteria (CTC), version 3, greater than or equal to grade 3 skin reactions were 23% and 41%, but rates by skin care product were identical at 32%. There was no significant difference between MDBC and sorbolene in the primary endpoint of peak skin reactions or secondary endpoints of area-under-the-curve skin reaction scores.
  
  
  CONCLUSIONS
  The MDBC did not reduce the peak skin reaction compared to sorbolene. It is possible that this is related to the difference in the formulation of the cream compared with the film formulation. Skin dosimetry verification and double blinding are essential for radiation skin care comparative studies.
authors: Cancer Care Centre, St George Hospital, Kogarah, New South Wales, Australia. peter.graham@sesiahs.health.nsw.gov.au
authors: Peter H
authors: PH
authors: Graham
authors: Natalie
authors: N
authors: Plant
authors: Jennifer L
authors: JL
authors: Graham
authors: Lois
authors: L
authors: Browne
authors: Martin
authors: M
authors: Borg
authors: Anne
authors: A
authors: Capp
authors: Geoff P
authors: GP
authors: Delaney
authors: Jennifer
authors: J
authors: Harvey
authors: Lisbeth
authors: L
authors: Kenny
authors: Michael
authors: M
authors: Francis
authors: Yvonne
authors: Y
authors: Zissiadis
mesh_terms: D000179:Acrylates / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019540:Area Under Curve; D003879:Dermatologic Agents; D004311:Double-Blind Method; D004643:Emollients / Q000008:administration & dosage; D005260:Female; D005990:Glycerol / Q000008:administration & dosage*; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D011108:Polymers / Q000008:administration & dosage; D011182:Postoperative Care / Q000379:methods*; D011832:Radiation Injuries / Q000517:prevention & control*; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D012867:Skin / Q000528:radiation effects*; D063465:Skin Cream / Q000008:administration & dosage*
chemical_list: D000179:Acrylates; D003879:Dermatologic Agents; D004643:Emollients; D011108:Polymers; D011837:Radiation-Protective Agents; D005990:Glycerol