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A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial

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Abstract

Purpose

To investigate the efficacy of a novel, multi-active emollient in preventing and managing acute radiation dermatitis (ARD) in breast cancer patients undergoing moderate hypofractionated (HF) radiotherapy (RT) compared to standard of care.

Methodsa

A monocentric, open-label, randomized clinical trial (RCT) with breast cancer patients receiving moderate HF (dose: 40.05–55.86 Gy, fractions: 15–21) was conducted between January 2022 and May 2023. The experimental group received the novel emollient, while the control group received the standard skin care. Patients applied the skin care products twice daily during the complete RT course. The primary outcome was the severity of ARD at the final RT session measured by the modified Radiation Therapy Oncology Group (RTOG) criteria. Secondary outcomes included patient symptoms, quality of life (QoL), and treatment satisfaction.

Results

A total of 100 patients with 50 patients per group were enrolled. In the control group, 50% of the patients developed RTOG grade 1 ARD and 48% grade 2 or higher, while in the experimental group, the severity of ARD was significantly lower with 82% grade 1 and 16% grade 2 ARD (P = .013, χ2-test). The frequency and severity of xerosis were significantly lower in the experimental compared to the control group (Ps ≤ .036, Mann Whiney U test). The impact of ARD on the QoL was low, and treatment satisfaction was high in both groups, with no significant difference.

Conclusion

This RCT shows that the novel, multi-active emollient significantly reduced the ARD RTOG grade. Research in a more diverse patient population is warranted.

Trial registration

ClinicalTrials.gov: NCT04929808 (11/06/2021).

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Acknowledgements

This study is part of Limburg Clinical Research Center (LCRC), supported by Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital.

Funding

This research is funded by the Limburg Clinical Research Center (LCRC) UHasselt-ZOL-Jessa, and the “Limburgs Kankerfonds.”

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Authors and Affiliations

  1. Faculty of Medicine and Life Sciences, LCRC, Hasselt University, Agoralaan, 3590, Diepenbeek, Belgium

    Jolien Robijns, Marithé Claes, Joy Lodewijckx, Laura Tuts, Eline Vandaele & Jeroen Mebis

  2. Dept. Oncology and Dept, Jessa & Science, LCRC, Jessa Hospital, Salvatorstraat 20, 3500, Hasselt, Belgium

    Jolien Robijns, Marithé Claes, Joy Lodewijckx & Jeroen Mebis

  3. Dept. Radiotherapy - Limburg Oncology Center, Jessa Hospital – Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium

    Leen Van Bever, Sanne Hermans, Evelien Vinken, Leen Noé, Katleen Verboven, Annelies Maes, Anne-Sophie Van de Velde, Paul Bulens, Philippe Bulens, Laura Van den Bergh & Jeroen Mebis

  4. Department of Surgery GROW School for Oncology & Reproduction, Maastricht University, Universiteitssingel 50, 6229ER, Maastricht, The Netherlands

    Melissa Lenaerts

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  1. Jolien Robijns
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Contributions

Conceptualization: J.R., J.M.; Methodology: J.R., J.M.; Formal analysis: J.R.; Investigation: J.R., L.V.B., S.H., M.C., J.L., L.T., M.L., E.V., J.M.; Writing – original draft: J.R.; Writing – review and editing: J.R., M.C., J.L., M.L., L.T., L.V.B., S.H., J.M., E.V., L.N., A.M., L. V. D. B., P. B., PH. B., A. S. V. D. V., K.V, E.V.

Corresponding author

Correspondence to Jolien Robijns.

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The ethical committees of the Jessa Hospital and the University of Hasselt approved the trial (B2432021000014).

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The authors declare no competing interests.

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Robijns, J., Van Bever, L., Hermans, S. et al. A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial. Support Care Cancer 31, 625 (2023). https://doi.org/10.1007/s00520-023-08096-5

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