Natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer: A phase 3, double-blind, randomized, controlled trial

Raymond Javan Chan, Jennifer Mann, Lee Tripcony, Jacqui Keller, Robyn Cheuk, Rae Blades, Samantha Keogh, Christopher Poole, Christopher Walsh

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    21 Citations (Scopus)

    Abstract

    Purpose: To investigate the effects of a natural oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation-induced skin reactions.

    Methods and Materials: A total of 174 patients were randomized and participated in the study. Patients received either cream 1 (the natural oil-based emulsion containing allantoin) or cream 2 (aqueous cream). Skin toxicity, pain, itching, and skin-related quality of life scores were collected for up to 4 weeks after radiation treatment.

    Results: Patients who received cream 1 had a significantly lower average level of Common Terminology Criteria for Adverse Events at week 3 (P<.05) but had statistically higher average levels of skin toxicity at weeks 7, 8, and 9 (all P<.001). Similar results were observed when skin toxicity was analyzed by grades. With regards to pain, patients in the cream 2 group had a significantly higher average level of worst pain (P<.05) and itching (P=.046) compared with the cream 1 group at week 3; however, these differences were not observed at other weeks. In addition, there was a strong trend for cream 2 to reduce the incidence of grade 2 or more skin toxicity in comparison with cream 1 (P=.056). Overall, more participants in the cream 1 group were required to use another topical treatment at weeks 8 (P=.049) and 9 (P=.01).

    Conclusion: The natural oil-based emulsion containing allantoin seems to have similar effects for managing skin toxicity compared with aqueous cream up to week 5; however, it becomes significantly less effective at later weeks into the radiation treatment and beyond treatment completion (week 6 and beyond). There were no major differences in pain, itching, and skin-related quality of life. In light of these results, clinicians and patients can base their decision on costs and preferences. Overall, aqueous cream seems to be a more preferred option.

    Original languageEnglish
    Pages (from-to)756-764
    Number of pages9
    JournalInternational Journal of Radiation Oncology Biology Physics
    Volume90
    Issue number4
    DOIs
    Publication statusPublished - 15 Nov 2014

    Bibliographical note

    Funding Information:
    This study received research grants and sponsorship from the Office of Medical and Health Research , Queensland Health, and the RBWH Foundation . The study also received financial support in the form of an unconditional donation and in-kind support through the supply of products for the study from Moogoo Skin Care. Moogoo Skin Care did not design the study protocol, collect or analyze data, and did not prepare the manuscript. None of the authors have any professional, consultancy, or commercial connection with the manufacturer.

    Publisher Copyright:
    © 2014 Elsevier Inc.

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