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: | , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
19 March 2025
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| 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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| 520 | |a 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. | ||
| 650 | 4 | |a Breast cancer | |
| 650 | 4 | |a Cold atmospheric plasma | |
| 650 | 4 | |a Non-invasive physical plasma | |
| 650 | 4 | |a Radiation dermatitis | |
| 650 | 4 | |a Radiation therapy | |
| 650 | 4 | |a Randomised controlled trial | |
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| 700 | 1 | |a Sarria, Gustavo Renato |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wiegreffe, Shari |e VerfasserIn |4 aut | |
| 700 | 1 | |a Glasmacher, Andrea Renate |e VerfasserIn |4 aut | |
| 700 | 1 | |a Nour, Younèss |e VerfasserIn |4 aut | |
| 700 | 1 | |a Scafa, Davide |e VerfasserIn |4 aut | |
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