Gehr, Nina Lykkegaard
Karlsson, Páll
Timm, Signe
Christensen, Signe
Hvid, Christian Andreas
Peric, Jana
Hansen, Torben Frøstrup
Lauritzen, Lotte
Finnerup, Nanna Brix
Ventzel, Lise
Funding for this research was provided by:
Novo Nordisk Fonden (NNF 20OC0065520, NNF 20OC0065520, NNF 20OC0065520)
Fondation Idella
Lundbeck Foundation (R359-2020-2620, R359-2020-2620)
Article History
Received: 13 October 2023
Accepted: 8 January 2024
First Online: 3 February 2024
Declarations
:
: The project will abide by the Declaration of Helsinki II and the Danish laws and regulations.The study has been approved by The Regional Committee on Health Research Ethics for Southern Denmark (VEK no. 2022-0022, May 5th, 2022) and the data protection agency of the Region of Southern Denmark. (no. 22/22132, May 15<sup>th</sup>, 2022).Protocol amendments and modifications will be submitted for approval at relevant authorities and all relevant collaborators will be informed by the trial coordinating team.Fish oil with EPA and DHA is approved by the Danish Medicines Agency as a supplement and is not seen as a medical drug. There are no known serious side effects to the study supplementation (n-3 LCPUFAs or corn oil) and studies have documented no risk of reducing the effect of chemotherapy due to interaction.Eligible patients will be given both verbal and written information by the sponsor, site-investigators or experienced oncologist trained in the protocol and only informed consent will be obtained. Participation in the study is entirely voluntary. If the patient declines to participate in the study, it will not influence the oncological treatment plan in any way. No remuneration will be paid to patients for participation.Data will be stored and handled through the REDCap® (Research Electronic Data Capture) [CitationRef removed] system in cooperation with the Open Patient Explorative Network (OPEN) organization, Southern University of Denmark. Information on trial subjects is protected by the Data Protection Act and the General Data Protection Regulation.All patient data will be handled in accordance with the Danish protection laws (“ Databeskyttelsesreglerne, loven og -forordninger”) and the Danish adaptation of the European Union General Data Protection Regulation (GDPR). No new research examinations of biobank material will be carried out without the permission of the Danish Ethics Committee.
: Not applicable.The results from the study will be published in international peer-reviewed journals and presented at relevant meetings independent of the study outcome. The Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and flow diagram will be used- when presenting the results of the present study. Data will be made public at clinicaltrials.gov. Authorship and distribution hereof will follow the international committee of medical journal editors (ICMJE) guidelines [CitationRef removed].
: The authors declare no competing interests.