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Treatment of Acute Radiodermatitis with an Oil-in-Water Emulsion Following Radiation Therapy for Breast Cancer

A Controlled, Randomized Trial

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Background:

A side effect of radiotherapy for breast cancer is acute radiodermatitis. It is a common practice to keep irradiated skin dry on account of data from the 1950s that suggested this regimen limits dermatitis. However, severe dryness of the skin induced by irradiation results in itching and discomfort. Dry skin is characterized by scaliness, epidermal barrier dysfunction, and reduced stratum corneum hydration, and these signs and symptoms are reduced by treatment with an emulsion.

Patients and Methods:

We performed a randomized, controlled, open-label study with 66 patients (ITT population), treating the irradiated skin in one group (n = 34) with an oil-in-water emulsion (WO1932), while leaving the other group untreated (n = 32). Clinical scoring (ONS radiation skin reaction scoring, pruritus) and biophysical measurements (stratum corneum hydration and transepidermal water loss (TEWL), as a marker of skin barrier function) were determined at day 1 (directly after termination of the radiation therapy), day 8, and day 47 (± 7).

Results:

Irradiation increased the ONS score and pruritus, whereas skin hydration and TEWL were reduced. The primary hypothesis that the increase in skin hydration was significantly greater in the emulsion-treated compared to the untreated group as early as after 8 days of treatment could not be confirmed. At the end of the study (day 47 ± 7), however, normalization of stratum corneum hydration was more advanced in the treatment group compared to the untreated group and nearly reached the values of the contralateral healthy breast skin. ONS score and pruritus also revealed an advantage for the emulsion-treated group. TEWL did not show significant changes during emulsion treatment. No adverse events were caused by the treatment regimens

Conclusion:

Treatment of radiodermatitis with an oil-in-water emulsion was well tolerated, enhanced stratum corneum hydration, improved clinical indicators, and provided relief from itching.

Hintergrund:

Eine häufige Nebenwirkung der Strahlentherapie bei Brustkrebs ist die Radiodermatitis. Üblicherweise wird die Haut trocken gehalten, da nach Untersuchungen aus den 50er Jahren so die Haut am wenigsten geschädigt wird. Starke Hauttrockenheit im Rahmen der Bestrahlung führt jedoch zu Missempfindungen und Juckreiz. Trockene Haut weist eine Schuppung, eine Hautbarrierestörung und einen erniedrigten Wassergehalt des Stratum corneum auf.

Patienten und Methoden:

In einer kontrollierten, randomisierten, unverblindeten Studie behandelten wir 34 von 66 Brustkrebspatientinnen (ITT-Population) mit einer Öl-in-Wasser-Emulsion (WO1932), 32 Patienten blieben unbehandelt. Wir untersuchten den klinischen Befund (ONS-Score), fragten nach dem Juckreiz und führten biophysikalische Messungen des Wassergehalts des Stratum corneum und des transepidermalen Wasserverlusts (TEWL) als Marker der Hautbarrierefunktion am 1., 8. und letzten Tag (Tag 47 ± 7) durch.

Ergebnisse:

Die Bestrahlung führte zu erhöhten ONS- und Prurituswerten und erniedrigten Werten des Wassergehalts der Haut und des TEWL. Die primäre Hypothese, dass sich die Hauthydration bereits nach 8 Tagen Behandlung gegenüber der unbehandelten Gruppe signifikant verbesserte, konnte nicht bestätigt werden. Jedoch hatte sich nach 47 ± 7 Tagen in der Behandlungsgruppe der erniedrigte Wassergehalt des Stratum corneum weitgehend normalisiert. Im Gegensatz zur unbehandelten Kontrollgruppe wurden in der Behandlungsgruppe auf der bestrahlten Brust fast die Werte der kontralateralen, gesunden Brust erreicht. Der Juckreiz und die ONS-Punktzahl nahmen stärker in der Behandlungsgruppe ab. Klinisch zeigte sich eine stärker ausgeprägte Besserung der Symptome in der Cremetherapiegruppe. Der TEWL als Marker der Barriere änderte sich nicht signifikant. Die Behandlung führte zu keinen unerwünschten Nebenwirkungen.

Schlussfolgerung:

Die Behandlung mit der Emulsion wurde gut toleriert. Die Ergebnisse zeigen, dass WO1932 das klinische Bild verbesserte, den Wassergehalt des Stratum corneum erhöhte und den Juckreiz reduzierte.

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Correspondence to Jens-Michael Jensen MD.

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Jensen, JM., Gau, T., Schultze, J. et al. Treatment of Acute Radiodermatitis with an Oil-in-Water Emulsion Following Radiation Therapy for Breast Cancer. Strahlenther Onkol 187, 378–384 (2011). https://doi.org/10.1007/s00066-011-2224-8

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  • DOI: https://doi.org/10.1007/s00066-011-2224-8

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