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      Emulsion of Olive Oil and Calcium Hydroxide for the Prevention of Radiation Dermatitis in Hypofractionation Post-Mastectomy Radiotherapy: A Randomized Controlled Trial

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          Abstract

          Background: Most of the patients who have been treated by post-mastectomy radiotherapy (PMRT) experience skin toxicity. There have been few studies on acute radiation dermatitis in breast cancer patients who received hypofractionation PMRT. Methods: 62 patients were randomized to receive a general skin care regimen with or without the addition of an emulsion of olive oil and calcium hydroxide twice a day, from the initiation of PMRT to 2 weeks after radiotherapy. Adverse skin reactions and the Skindex-16 score were assessed. Results: At the 8th, 13th, and 16th fraction of PMRT, grade 1 dermatitis was found in 42, 90, and 90% of the control group and in 16, 30, and 71% of the intervention group. At the end of the study, the mean Skindex-16 score of the intervention group was significantly better than that of the control group (p = 0.019). Conclusions: Addition of an emulsion of olive oil and calcium hydroxide for patients undergoing hypofractionation PMRT yielded superior preventive results over a general skin care regimen alone, in terms of delaying skin toxicity, reducing the severity of acute radiation dermatitis, and a better quality of life in the intervention group. However, a larger number of patients will be required to confirm this result.

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          Most cited references30

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          Radiation dermatitis: clinical presentation, pathophysiology, and treatment 2006.

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            Prophylaxis and management of acute radiation-induced skin reactions: a systematic review of the literature.

            Radiation therapy is a common treatment for cancer patients. One of the most common side effects of radiation is acute skin reaction (radiation dermatitis) that ranges from a mild rash to severe ulceration. Approximately 85% of patients treated with radiation therapy will experience a moderate-to-severe skin reaction. Acute radiation-induced skin reactions often lead to itching and pain, delays in treatment, and diminished aesthetic appearance-and subsequently to a decrease in quality of life. Surveys have demonstrated that a wide variety of topical, oral, and intravenous agents are used to prevent or to treat radiation-induced skin reactions. We conducted a literature review to identify trials that investigated products for the prophylaxis and management of acute radiation dermatitis. Thirty-nine studies met the pre-defined criteria, with thirty-three being categorized as prophylactic trials and six as management trials.For objective evaluation of skin reactions, the Radiation Therapy Oncology Group criteria and the U.S. National Cancer Institute Common Toxicity Criteria were the most commonly used tools (65% of the studies). Topical corticosteroid agents were found to significantly reduce the severity of skin reactions; however, the trials of corticosteroids evaluated various agents, and no clear indication about a preferred corticosteroid has emerged. Amifostine and oral enzymes were somewhat effective in preventing radiation-induced skin reactions in phase II and phase III trials respectively; further large randomized controlled trials should be undertaken to better investigate those products. Biafine cream (Ortho-McNeil Pharmaceuticals, Titusville, NJ, U.S.A.) was found not to be superior to standard regimes in the prevention of radiation-induced skin reactions (n = 6).In conclusion, the evidence is insufficient to support the use of a particular agent for the prevention and management of acute radiation-induced skin reactions. Future trials should focus on comparing agents and approaches that, in phase I and II trials, suggest efficacy. These future phase III randomized controlled trials must clearly distinguish between preventive and management strategies for radiation-induced dermatitis. Only then can evidence-based guidelines be developed, with the hope of standardizing the approach across centres and of improving the prevention and management of radiation-induced dermatitis.
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              Critical review of generic and dermatology-specific health-related quality of life instruments.

              The measurement of health-related quality of life (HRQOL) is increasingly important in patients with skin diseases. Despite the availability of a variety of instruments and new psychometric techniques, there is no consensus as to which HRQOL instruments are to be preferred in dermatology. The objective of this review is to evaluate the generic HRQOL measures (i.e., health profiles) that have been used in dermatology (Short-Form-36 (SF-36) and -12, NHP, SIP, World Health Organization Quality of Life (WHOQOL)-100 and -BREF) and all dermatology-specific HRQOL measures (Dermatology Life Questionnaire Index, Skindex-29, -16, and -17, Dermatology Quality of Life Scales, and Dermatology-Specific Quality of Life). Criteria for evaluation were adapted from existing guidelines and included conceptual and measurement model, reliability, validity, responsiveness, item functioning, meaning of scores, administrative burden, respondent burden, the availability of alternative forms, and of cultural and language adaptations. Furthermore, an overview of skin diseases in which the included HRQOL tools have been used is presented. Although the selection of the appropriate HRQOL instrument remains a trade-off between various psychometric properties and research objectives, for now, we recommend the combination of SF-36 and Skindex-29 as the instruments of choice in dermatology. Promising new instruments for future research are the WHOQOL and the Skindex-17.
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                Author and article information

                Journal
                BRC
                BRC
                10.1159/issn.1661-3791
                Breast Care
                S. Karger AG
                1661-3791
                1661-3805
                2019
                December 2019
                05 February 2019
                : 14
                : 6
                : 394-400
                Affiliations
                aDivision of Radiation Oncology, bNorthern Thai Research Group of Radiation Oncology (NTRG-RO), cChiang Mai Cancer Registry, Maharaj Nakorn Chiang Mai Hospital, and dDivision of Dermatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
                Author notes
                *Imjai Chitapanarux, MD, Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University, 110 Intawarorose Road, Chiang Mai 50200 (Thailand), E-Mail imjai@hotmail.com and imjai.chitapanarux@cmu.ac.th
                Author information
                https://orcid.org/0000-0002-8552-0149
                Article
                496062 PMC6940468 Breast Care 2019;14:394-400
                10.1159/000496062
                PMC6940468
                31933586
                f0284e84-009d-4fe5-8290-4b6db1d0e400
                © 2019 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                Page count
                Figures: 1, Tables: 2, References: 35, Pages: 7
                Categories
                Research Article

                Oncology & Radiotherapy,Pathology,Surgery,Obstetrics & Gynecology,Pharmacology & Pharmaceutical medicine,Hematology
                Olive oil,Skin toxicity,Calcium hydroxide,Hypofractionation,Post-mastectomy radiotherapy

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