Title {1} | Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing a reminder app to reduce radiation dermatitis in patients with head-and-neck cancer |
Trial registration {2a and 2b}. | NCT04110977, clinicaltrials.gov |
Protocol version {3} | 09-30-2019, version 2.0 |
Funding {4} | As part of the project NorDigHealth, the RAREST-02 trial was funded by the European Regional Development Fund through the Interreg Deutschland-Danmark program, reference: 087–1.1-18. |
Author details {5a} |
(1) Dirk Rades, Department of Radiation Oncology, University of Lübeck, Lübeck, Germany; rades.dirk@gmx.net (2) Carlos Andres Narvaez, Department of Radiation Oncology, University of Lübeck, Lübeck, Germany; carlos.narvaez@uksh.de (3) Claudia Doemer, Department of Radiation Oncology, University of Lübeck, Lübeck, Germany;claudia.doemer@uksh.de (4) Stefan Janssen, Medical Practice for Radiotherapy and Radiation Oncology, Hannover, Germany; st-janssen@gmx.net (5) Denise Olbrich, Centre for Clinical Trials Lübeck, Lübeck, Germany; olbrich@zks.uni-luebeck.de (6) Soeren Tvilsted, Research Projects and Clinical Optimization, Zealand University Hospital, Koege, Denmark; sotv@regionsjaelland.dk (7) Antonio J. Conde-Moreno, Department of Radiation Oncology, Hospital Universitario y Politecnico La Fe, Valencia, Spain; antoniojconde@gmail.com (8) Jon Cacicedo, Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute, Barakaldo, Vizcaya, Spain; JON.CACICEDOFERNANDEZBOBADILLA@osakidetza.eus |
Name and contact information for the trial sponsor {5b} |
Sponsor: University Hospital Schleswig-Holstein (UKSH), Campus Lübeck Ratzeburger Allee 160, 23,538 Lübeck, Germany Coordinating Investigator (contact) Prof. Dr. Dirk Rades Department of Radiation Oncology University of Lübeck Ratzeburger Allee 160 23,538 Lübeck, Germany. Tel.: + 49-(0)451–500-45,400 Fax: + 49-(0)451–500-45,404 Email: Rades.Dirk@gmx.net |
Role of sponsor {5c} | The sponsor and the funding body have no role in the design of the study, in collection, analysis and interpretation of the data and in the writing of the manuscript. |