Abstract
BackgroundRadiation-induced skin reaction (RISR) is one of the most common and distressing side effects of radiotherapy in patients with cancer. It is featured with swelling, redness, itching, pain, breaks in skin, discomfort, and a burning sensation. There is a lack of convincing evidence supporting any single practice in the prevention or management of RISR.Methods/DesignsThis double-blinded randomised controlled trial aims to investigate the effects of a natural oil-based emulsion containing allantoin (as known as Moogoo Udder Cream®) versus aqueous cream in reducing RISR, improving pain, itching and quality of life in this patient group. One group will receive Moogoo Udder Cream®. Another group will receive aqueous cream. Outcome measures will be collected using patient self-administered questionnaire, interviewer administered questionnaire and clinician assessment at commencement of radiotherapy, weekly during radiotherapy, and four weeks after the completion of radiotherapy.DiscussionDespite advances of radiologic advances and supportive care, RISR are still not well managed. There is a lack of efficacious interventions in managing RISR. While anecdotal evidence suggests that Moogoo Udder Cream® may be effective in managing RISR, research is needed to substantiate this claim. This paper presents the design of a double blind randomised controlled trial that will evaluate the effects of Moogoo Udder Cream® versus aqueous cream for managing in RISR in patients with cancer.Trial registrationACTRN 12612000568819
Highlights
Radiation-induced skin reaction (RISR) is one of the most common and distressing side effects of radiotherapy in patients with cancer
There is a lack of efficacious interventions in managing RISR
While anecdotal evidence suggests that Moogoo Udder CreamW may be effective in managing RISR, research is needed to substantiate this claim
Summary
Despite advances of radiologic technology and supportive care, RISR are still not well managed. While anecdotal evidence suggests that Moogoo Udder CreamW may be effective in managing RISR, research is needed to substantiate this claim. This paper presents the design of a double blind randomised controlled trial that will evaluate the effects of Moogoo Udder CreamW versus aqueous cream for managing in RISR in patients with cancer. Competing interests The products used in this trial will be provided by the manufacturer (Moogoo Skin Care) free of charge. None of the investigators own any shares of the tested products in any form. We declare that this is an investigator initiated trial. Authors’ contributions RJC drafted and coordainted the development of the manuscript. All authors contributed to the development of this protocol. All authors read and approved the final manuscript
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