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, RN, BN, MAppSc(Research), PhD, FACN^∗^,^†^,^‡^,^,,
Jennifer Mann, RN, BN, GradCertHlthSc^∗,
Lee Tripcony, BSc^∗,
Jacqui Keller, BBus(HIM)^∗,
Robyn Cheuk, BMBS, FRANZCR^∗,
Rae Blades, RN, BN, GradCertNursing^∗,
Samantha Keogh, RN, PhD^§,
Christopher Poole, BEng, MSc, PhD^∗^,^||,
Christopher Walsh, BAppSc^∗

doi:10.1016/j.ijrobp.2014.06.034

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Erratum to: Chan RJ, Mann J, Tripcony L, et al. 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. Int J Radiat Oncol Biol Phys 2014 Aug 20 [Epub ahead of print]. http://dx.doi.org/10.1016/j.ijrobp.2014.06.034.
International Journal of Radiation Oncology*Biology*Physics, Volume 90, Issue 5, 1 December 2014, Page 1262
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Gary M. Freedman
Topical Agents for Radiation Dermatitis in Breast Cancer: 50 Shades of Red or Same Old, Same Old?
International Journal of Radiation Oncology*Biology*Physics, Volume 90, Issue 4, 15 November 2014, Pages 736-738
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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.

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.

Conflict of interest: none.

: Reprint requests: Raymond Javan Chan, PhD, Royal Brisbane and Women's Hospital, Level 2, Building 34, Herston Q4029, Australia. Tel: (+61) 7-3646-5833

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Tuesday, 11 August 2015