Status:
COMPLETED
Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Federation Francophone de Cancerologie Digestive
Conditions:
Digestive Oncology
Supportive Care
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The use of oxaliplatin in the treatment of colorectal or pancreas cancer induces (\>75% of patients) severe sensorimotor neuropathy decreasing the quality of life of cancer survivors. Today, no treatm...
Eligibility Criteria
Inclusion
- Patient who received chemotherapy with oxaliplatin for all stage of colorectal or pancreas cancer,
- QLQ-CIPN20 sensory score ≥30,
- Diagnosis of chemotherapy-induced peripheral neuropathy treated or not by stable antineuropathic/analgesic treatment (opioids, pregabalin, gabapentin, duloxetine and other antidepressants or anticonvulsants) for at least 1 month,
- Chemotherapy completed for at least 6 months,
- Patients affiliated to the French national health insurance,
- Written informed consent,
- French language comprehension.
Exclusion
- 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.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05254639
Start Date
June 2 2022
End Date
January 24 2024
Last Update
April 5 2024
Active Locations (34)
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1
Hôpital privé d'Antony
Antony, France
2
CH d'Argenteuil
Argenteuil, France
3
CHU de Besançon
Besançon, France
4
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France