A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN)

Dirk Rades; Carlos A Narvaez; Laura Splettstößer; Claudia Dömer; Cornelia Setter; Christian Idel; Julika Ribbat-Idel; Sven Perner; Tobias Bartscht; Denise Olbrich; Steven E Schild; Jesper Carl

doi:10.1016/j.radonc.2019.07.023

A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN)

Radiother Oncol. 2019 Oct:139:79-82. doi: 10.1016/j.radonc.2019.07.023. Epub 2019 Aug 17.

Authors

Affiliations

¹ Department of Radiation Oncology, University of Luebeck, Germany. Electronic address: [email protected].
² Department of Radiation Oncology, University of Luebeck, Germany.
³ Department of Radiation Oncology, Christian-Albrechts University Kiel, Germany.
⁴ Department of Radiation Oncology, University of Luebeck, Germany; Department of Radiation Oncology and Department of Oto-Rhino-Laryngology and Head and Neck Surgery, University of Luebeck, Germany.
⁵ Institute of Pathology, University Hospital Schleswig-Holstein, Luebeck, Germany.
⁶ Institute of Pathology, University Hospital Schleswig-Holstein, Luebeck, Germany; Pathology, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.
⁷ Department of Hematology & Medical Oncology, University of Luebeck, Germany.
⁸ Centre for Clinical Trials Luebeck, Germany.
⁹ Department of Radiation Oncology, Mayo Clinic, Scottsdale, USA.
¹⁰ Department of Oncology & Palliative Units, Zealand University Hospital, Naestved, Denmark.

PMID: 31431372
DOI: 10.1016/j.radonc.2019.07.023

Abstract

Mepitel® Film (MEP) and standard care (STD) were compared for radiation dermatitis in SCCHN patients. This trial was stopped prematurely since13/28 patients did not tolerate MEP. Grade ≥2 dermatitis: 34.8% (MEP) vs. 35.7% (STD) at 50 Gy, 65.2% vs. 59.3% at 60 Gy. MEP was unsatisfactorily tolerated and appeared not superior (NCT03047174).

Keywords: Head-and-neck cancer; Mepitel® Film; Radiation dermatitis; Randomized trial; Standard care.

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Female
Head and Neck Neoplasms / radiotherapy*
Humans
Male
Middle Aged
Radiodermatitis / prevention & control*
Silicones / adverse effects
Silicones / therapeutic use*
Squamous Cell Carcinoma of Head and Neck / radiotherapy*

Substances

Silicones
mepitel

Associated data

ClinicalTrials.gov/NCT03047174