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The numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).
Title {1} | 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) |
Trial Registration {2a and 2b} | This trial has been registered prospectively in the German Clinical Trial Registry (DRKS) on January 9th 2024, identifier DRKS00032560. |
Protocol Version {3} | Version 1.0 of the protocol from November 9th, 2023. |
Funding {4} | This trial is funded by the Förderinstrument Klinische Studien of the University Bonn, Germany (grant number 2023 − FKS − 05). The devices are provided free of charge by terraplasma medical (Garching, Germany). |
Author Details {5a} | Cas Stefaan Dejonckheere: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany ([email protected]); Julian Philipp Layer: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany and Institute of Experimental Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Gustavo Renato Sarria: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Shari Wiegreffe: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Andrea Renate Glasmacher: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Younèss Nour: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Davide Scafa: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Thomas Müdder: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Teresa Anzböck: Department of Gynaecology and Gynaecological Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Frank Anton Giordano: Department of Radiation Oncology, University Medical Center Mannheim, 68,167 Mannheim, Germany and DKFZ-Hector Cancer Institute, University Medical Center Mannheim, 68,167 Mannheim, Germany; Matthias Bernhard Stope: Department of Gynaecology and Gynaecological Oncology, Physical Plasma Laboratories, University Hospital Bonn, 53,127 Bonn, Germany; Eleni Gkika: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany; Leonard Christopher Schmeel: Department of Radiation Oncology, University Hospital Bonn, 53,127 Bonn, Germany. |
Name and Contact Information for the Trial Sponsor {5b} | Department of Radiation Oncology University Hospital Bonn Venusberg-Campus 1 53,127 Bonn Germany |
Role of Sponsor {5c} | The sponsor and funding body have no role in the design of the study, in collection, analysis, and interpretation of the data or in the writing of the manuscript. |
Introduction
Background and...