Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study

Exclusion Criteria

• •Cancer relapse or secondary cancer,
• •Lack of effective contraception in patients (female) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not taken a pregnancy test,
• •Patient with a chronic progressive disease with associated chronic pain (excluding oxaliplatin-induced peripheral neuropathy),
• •Diabetic patient (excluding non-insulin- or insulin-treated diabetes less than 5 years old) or presence of proven diabetic neuropathy,
• •Other types of neuropathies,
• •ALT / AST elevated more than 3 times the normal values,
• •Severe cardiovascular disease (as determined by clinician), bradycardia (\< 55 bpm), cardiac conduction disorders such as sinus disease or other supraventricular conduction abnormalities such as sino-auricular or atrioventricular block (assessed by electrocardiogram),
• •History of peptic ulcer disease or active peptic ulcer disease,
• •Asthma or chronic obstructive pulmonary disease,
• •Known allergy to donepezil or piperidine derivatives,
• •Known galactose intolerance, known Lapp lactase deficiency or known glucose or galactose malabsorption syndrome (rare hereditary diseases),
• •Drug interactions: CYP3A4 inhibitors (ketoconazole, itraconazole and erythromycin); CYP2D6 inhibitors (fluoxetine, quinidine) and enzymatic inducers (rifampicin, phenytoin, carbamazepine),
• •Known dependence on alcohol and/or drugs,
• •Known psychotic disorders, patient under antipsychotics,
• •Planned surgery during the trial,
• •Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons,
• •Person under guardianship, curatorship, safeguard of justice or person deprived of liberty.