Zetzl, Teresa http://orcid.org/0000-0002-6326-0702
Renner, Agnes
Pittig, Andre
Jentschke, Elisabeth
Roch, Carmen
van Oorschot, Birgitt
Funding for this research was provided by:
Deutsche Krebshilfe (No.: 70112812, No: 70112812)
Article History
Received: 23 July 2020
Accepted: 18 September 2020
First Online: 7 October 2020
Compliance with ethical standards
:
: The authors declare that they have no competing interests.
: The investigation conforms to the principles outlined in the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of the University Würzburg on 15/05/2018 (Nr. 59/18 sc). Eligible patients will receive written information about all relevant aspects of the study and that their participation in the study is voluntary and they have the right to refuse or to withdraw their consent at any time without reprisals. Patients provide written informed consent. The study has been registered with the German Clinical Trials Register DRKS00016034). This paper contains the original study protocol. Any substantial modifications to the study protocol will be submitted to the Ethics Committee of the University Würzburg for approval prior to implementation. These amendments will be documented in detail in the German Clinical Trials Register and will be described transparently in trial reports. The study protocol was approved by the Ethics Committee of the University Würzburg on 15/05/2018 (Nr. 59/18 sc). After commencement, the design was modified through a reduction of the planned inclusion criteria (Fatigue > 5) [CitationRef removed] due to a very low recruitment rate of 11.3%.
: Not applicable.