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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

Purpose: 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 and Materials: 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 productmore » 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.« less

Authors:
 [1]; ; ;  [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8]
  1. Cancer Care Centre, St. George Hospital, Kogarah, New South Wales (Australia)
  2. Department of Radiation Oncology, Royal Adelaide Hospital (Australia)
  3. Department of Radiation Oncology, Mater Hospital, Newcastle, New South Wales (Australia)
  4. Cancer Care Centre, Liverpool Hospital, Liverpool, New South Wales (Australia)
  5. Mater Hospital, South Brisbane, Queensland (Australia)
  6. Royal Brisbane Hospital, Herston, Queensland (Australia)
  7. Andrew Love Cancer Centre, Geelong (Australia)
  8. Department of Radiation Oncology, Royal Perth Hospital, Perth (Australia)
Publication Date:
OSTI Identifier:
22224441
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 86; Journal Issue: 1; Other Information: Copyright (c) 2013 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ACRYLATES; ALCOHOLS; ATP; CHEST; DOSIMETRY; IMAGES; IRRADIATION; PAIN; PATIENTS; RADIATION DOSES; SKIN; TOXICITY; VERIFICATION

Citation Formats

Graham, Peter H., E-mail: peter.graham@sesiahs.health.nsw.gov.au, Plant, Natalie, Graham, Jennifer L., Browne, Lois, Borg, Martin, Capp, Anne, Delaney, Geoff P., Harvey, Jennifer, Kenny, Lisbeth, Francis, Michael, and Zissiadis, Yvonne. 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. United States: N. p., 2013. Web. doi:10.1016/J.IJROBP.2012.12.009.
Graham, Peter H., E-mail: peter.graham@sesiahs.health.nsw.gov.au, Plant, Natalie, Graham, Jennifer L., Browne, Lois, Borg, Martin, Capp, Anne, Delaney, Geoff P., Harvey, Jennifer, Kenny, Lisbeth, Francis, Michael, & Zissiadis, Yvonne. 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. United States. doi:10.1016/J.IJROBP.2012.12.009.
Graham, Peter H., E-mail: peter.graham@sesiahs.health.nsw.gov.au, Plant, Natalie, Graham, Jennifer L., Browne, Lois, Borg, Martin, Capp, Anne, Delaney, Geoff P., Harvey, Jennifer, Kenny, Lisbeth, Francis, Michael, and Zissiadis, Yvonne. Wed . "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". United States. doi:10.1016/J.IJROBP.2012.12.009.
@article{osti_22224441,
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},
author = {Graham, Peter H., E-mail: peter.graham@sesiahs.health.nsw.gov.au and Plant, Natalie and Graham, Jennifer L. and Browne, Lois and Borg, Martin and Capp, Anne and Delaney, Geoff P. and Harvey, Jennifer and Kenny, Lisbeth and Francis, Michael and Zissiadis, Yvonne},
abstractNote = {Purpose: 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 and Materials: 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.},
doi = {10.1016/J.IJROBP.2012.12.009},
journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 1,
volume = 86,
place = {United States},
year = {2013},
month = {5}
}