Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: study protocol for a phase 3 randomised double-blind placebo-controlled trial (NIPP-RD III)

Radiation dermatitis (RD) is the most common side effect of breast irradiation, yet only few potent preventative and therapeutic options are available. Following encouraging results from a phase 1 and 2 trial on the topical use of non-invasive physical plasma (NIPP), a very well-tolerated physical t...

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Main Authors: Dejonckheere, Cas S. (Author) , Layer, Julian Philipp (Author) , Sarria, Gustavo Renato (Author) , Wiegreffe, Shari (Author) , Glasmacher, Andrea Renate (Author) , Nour, Younèss (Author) , Scafa, Davide (Author) , Müdder, Thomas (Author) , Anzböck, Teresa (Author) , Giordano, Frank Anton (Author) , Stope, Matthias Bernhard (Author) , Schmeel, Leonard Christopher (Author) , Gkika, Eleni (Author)
Format: Article (Journal)
Language:English
Published: 19 March 2025
In: Trials
Year: 2025, Volume: 26, Pages: 1-10
ISSN:1468-6694
DOI:10.1186/s13063-025-08806-w
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1186/s13063-025-08806-w
Verlag, kostenfrei, Volltext: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08806-w
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Author Notes:Cas Stefaan Dejonckheere, Julian Philipp Layer, Gustavo Renato Sarria, Shari Wiegreffe, Andrea Renate Glasmacher, Younèss Nour, Davide Scafa, Thomas Müdder, Teresa Anzböck, Frank Anton Giordano, Matthias Bernhard Stope, Leonard Christopher Schmeel and Eleni Gkika
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Summary:Radiation dermatitis (RD) is the most common side effect of breast irradiation, yet only few potent preventative and therapeutic options are available. Following encouraging results from a phase 1 and 2 trial on the topical use of non-invasive physical plasma (NIPP), a very well-tolerated physical treatment option to promote tissue regeneration generated from ambient air, we now present the study protocol for a planned phase 3 trial.
Item Description:Gesehen am 23.07.2025
Physical Description:Online Resource
ISSN:1468-6694
DOI:10.1186/s13063-025-08806-w