Kerckhove, Nicolas http://orcid.org/0000-0003-2223-1240
Tougeron, David
Lepage, Côme
Pezet, Denis
Le Malicot, Karine
Pelkowski, Manon
Pereira, Bruno
Balayssac, David
Funding for this research was provided by:
Institut National Du Cancer (20-082 PHRC-K 2020)
Article History
Received: 9 May 2022
Accepted: 22 June 2022
First Online: 7 July 2022
Declarations
:
: The protocol has been approved by the competent authority since the 6 January 2022 (ref: MEDAECNAT-2021–11-0013_2021-005326–23; ANSM, Paris, France) and the ethics committee since the 24 January 2022 (ref: CPP 1444 ME1; CPP Ouest 6, Brest, France). Any substantial modification of the protocol and of the informed consent form will be presented to the independent medical ethics committee. The latter and the competent French authority will be informed of the end of the study.An independent Data Safety Monitoring Board (DSMB) will be set up to guarantee effective protection of the patients, ensure the ethical conduct of the trial, assess the benefit/risk ratio, and supervise the review of the scientific results during and at the end of the trial. The committee will meet annually and at the request of the sponsor. The committee will be independent of the sponsor and will consist of a CIPN neurologist, a donepezil neurologist, an oncologist and a biostatistician.The study is currently registered on the clinical trials website under the following number: NCT05254639. The protocol has been in version 4 since the 1<sup>st</sup> February 2022.According to the French law on biomedical research, written informed consent must be obtained from patients prior to participation in the study. Patients will voluntarily confirm their willingness to participate in the study, after having been informed (in writing and verbally) by the investigators of all the aspects of the study that are relevant to their decision to participate. They will be informed about requirements concerning data protection, good clinical practices and have to agree to direct access to their individual data. The patients will be informed that they are free to withdraw from the study at any time at their own discretion without necessarily giving reasons.Finally, the informed consent form was reviewed and validated by a patient association (ARCAD Foundation, committee of the League against Cancer – “Ligue contre le Cancer”).
: Not applicable.
: The authors declare that they have no competing interests. MYLAN will not provide donepezil free of charge and will not participate in any stage of the clinical study or analysis of the results.