Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study (DONEPEZOX)
Primary Purpose
Digestive Oncology, Supportive Care
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
DONEPEZIL
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Digestive Oncology focused on measuring Pharmacology, Chronic Pain, Oxaliplatin, Chemotherapy-induced peripheral neuropathy, Donepezil
Eligibility Criteria
Inclusion Criteria:
- 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 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,
- 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.
Sites / Locations
- Hôpital privé d'AntonyRecruiting
- CH d'Argenteuil
- CHU de BesançonRecruiting
- Polyclinique Bordeaux Nord AquitaineRecruiting
- Centre Hospitalier du Cotentin
- Centre Hospitalier Public du Cotentin
- CH de CholetRecruiting
- CHU clermont-ferrandRecruiting
- Centre Hospitalier Compiègne-NoyonRecruiting
- Clinique de FlandreRecruiting
- CHU de Dijon BourgogneRecruiting
- Institut de Cancérologie de Bourgogne - GRReCCRecruiting
- CHD de VendéeRecruiting
- CH Le puyRecruiting
- Hôpital Franco-BritaniqueRecruiting
- chu de LimogesRecruiting
- CH Saint Joseph Saint Luc
- Clinique de la sauvegarde
- Hôpital privé Jean Mermoz
- Hopital Saint Joseph de MarseilleRecruiting
- Hôpital Européen de MarseilleRecruiting
- Groupe Hospitalier des Portes de ProvenceRecruiting
- Hôpital Saint-Louis - AP-HPRecruiting
- Hôpital Privé des Cotes d'Armor
- CHU de PoitiersRecruiting
- Clinique La Croix du SudRecruiting
- CHU de ReimsRecruiting
- Institut GodinotRecruiting
- CHU de Saint-EtienneRecruiting
- Institut de Cancérologie Paris NordRecruiting
- Groupe Hospitalier Saint Vincent - Clinique Saint Anne
- CHU de BordeauxRecruiting
- Hôpital d'Instruction des Armées Sainte-Anne
- Hôpital d'Instruction des Armées Sainte-Anne
- CH de ValenceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Donepezil
Placebo
Arm Description
5 mg/day for 4 weeks then 10 mg/day for 12 weeks
5 mg/day for 4 weeks then 10 mg/day for 12 weeks
Outcomes
Primary Outcome Measures
Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20 (QLQ-CIPN20)
A self-reported questionnaire, consisting of 20 questions which assess the symptoms and functional limitations of CIPN from the patients' perspective. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of CIPN.
For each subscale and for the entire questionnaire, a score from 0 to 100 is generated. The higher the score, the more severe the neuropathic symptoms.
Secondary Outcome Measures
11-point pain Numeric Rating Scale (NRS)
The NRS is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. The score of 0 = No pain and 10 = worst possible pain.
Douleur Neuropathique-4 (DN4) interview
The interview portion of the DN4 questionnaire is a clinician-administered screening tool for neuropathic pain.
The questionnaire includes 7 items, grouped into two questions. Each item, is answered as either YES or NO.
A final cumulative patient's score is obtained by allocating 1 point for each YES and 0 point for each NO. If the patient's score ≥3/7, the test is positive.
This evaluation will be carried out only if the 11-point pain NRS ≥4/10.
Neuropathic Pain Symptoms Inventory (NPSI)
This self-reported questionnaire assesses different neuropathic pain symptoms. The French NPSI includes 12 items that discriminates and quantifies five distinct dimensions of neuropathic pain.
This evaluation will be carried out only if the 11-point pain NRS ≥4/10.
Quality of Life Questionnaire-Cancer 30 (QLQ-C30)
This EORTC self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
Hospital Anxiety and Depression scale (HADS)
This self-reported questionnaire permits to detect anxiety and depressive disorders. There are 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and 7 to the depressive dimension (total D), thus obtaining two scores (maximum score of each score = 21). To detect anxiety and depressive symptoms, the following interpretation is proposed for each of the scores (A and D):
≤7: absence of symptomatology
8 to 10: suspicious symptomatology
≥11: certain symptomatology
Patients' Global Impression of Change (PGIC)
PGIC is aimed at assessing the general effectiveness of the treatment. This scale consists of 7 level descriptors answering the question "How are you?" distributed in three ways: (i) improved (very/medium/slightly), (ii) unchanged and (iii) aggravated (slight/medium/very).
Full Information
NCT ID
NCT05254639
First Posted
February 4, 2022
Last Updated
April 25, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Federation Francophone de Cancerologie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT05254639
Brief Title
Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study
Acronym
DONEPEZOX
Official Title
Evaluation of the Efficacy of Donepezil in the Treatment of Oxaliplatin-induced Peripheral Neuropathy: Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Federation Francophone de Cancerologie Digestive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 treatment remains univocal for these peripheral neuropathies. But preclinical works have demonstrated that donepezil (acetylcholinesterase inhibitor use for Alzheimer's disease) was able to prevent and treat neuropathic symptoms in oxaliplatin-treated rats.
Present study aims to assess the therapeutic efficacy of donepezil on oxaliplatin-induced peripheral neuropathy (OIPN) in cancer survivors. Bibliographic data suggests an antineuropathic effect of donepezil in human and animal models. In clinic, a study have shown in healthy volunteers that donepezil (associated with gabapentin) reduced the pain threshold (better than gabapentin alone) caused by stimulation of the sural nerve, without severe adverse effect. Similarly, two studies in patients with neuropathic pain demonstrated that donepezil increases analgesic effect of gabapentin. Finally, a case report demonstrated an analgesic effect of donepezil in painful Alzheimer's disease patients. In animals, several studies demonstrated that donepezil induces analgesic and neuroprotective effects. Recently, a preclinical study demonstrated that donepezil induced antineuropathic effect in diabetic mice with neuropathic pain. Research unit INSERM U1107 (partner of the DONEPEZOX study) demonstrated the antineuropathic effects of donepezil in several animal models of chemotherapy-induced peripheral neuropathies, and very recently, a study have confirmed these results with oxaliplatin and cisplatin. These clinical and preclinical data have thus highlighted the potential beneficial effect of donepezil on neuropathic symptoms, without any significant adverse effects. Therefore the hypothesis is that the use of donepezil could reduce the symptoms of OIPN, limit the decrease in quality of life and the appearance of comorbidities (anxiety/depression) in cancer survivors.
For this purpose, the investigators propose here a proof of concept, multicentre, phase II, randomised, double-blind, placebo-controlled clinical study. The primary objective will be the curative efficacy of donepezil on the severity of OIPN in patients who have completed oxaliplatin-based chemotherapy for the treatment of colorectal or pancreas cancer and have peripheral neuropathy of grade ≥2. This will be assessed using the EORTC QLQ-CIPN20 sensory scale. Our methodological choice to use the QLQ-CIPN20 as the primary endpoint will allow us to more accurately (and in a standardized manner) characterize neuropathic symptoms and assess the therapeutic effect of donepezil on these symptoms. In addition, as secondary objectives, we will study the effect of donepezil on neuropathic pain, the intensity of neuropathic symptoms, health-related quality of life, and the tolerance of donepezil.
The 80 patients required will be randomized (1:1) to receive either placebo or donepezil (5 mg daily for 4 weeks and then 10 mg daily for 12 weeks as a single dose and according to tolerance and efficacy). Patients will be followed for 1 month after the end of treatment to assess the OIPN. As a proof of concept study, responder rate will be assessed only for Donepezil arm (primary objective) and compared between each treatment arm (secondary objective) after a minimum of 12 weeks of treatment. A responder will be defined as a patient with a decrease of neuropathic grade according to CIPN20 sensory score compraed to baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Oncology, Supportive Care
Keywords
Pharmacology, Chronic Pain, Oxaliplatin, Chemotherapy-induced peripheral neuropathy, Donepezil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Donepezil
Arm Type
Experimental
Arm Description
5 mg/day for 4 weeks then 10 mg/day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5 mg/day for 4 weeks then 10 mg/day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
DONEPEZIL
Intervention Description
5 mg daily for 4 weeks + 10 mg daily for 12 weeks according to tolerance or efficacy
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
5 mg daily for 4 weeks + 10 mg daily for 12 weeks according to tolerance or efficacy
Primary Outcome Measure Information:
Title
Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20 (QLQ-CIPN20)
Description
A self-reported questionnaire, consisting of 20 questions which assess the symptoms and functional limitations of CIPN from the patients' perspective. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of CIPN.
For each subscale and for the entire questionnaire, a score from 0 to 100 is generated. The higher the score, the more severe the neuropathic symptoms.
Time Frame
through study completion, an average of 4 months.
Secondary Outcome Measure Information:
Title
11-point pain Numeric Rating Scale (NRS)
Description
The NRS is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. The score of 0 = No pain and 10 = worst possible pain.
Time Frame
through study completion, an average of 4 months
Title
Douleur Neuropathique-4 (DN4) interview
Description
The interview portion of the DN4 questionnaire is a clinician-administered screening tool for neuropathic pain.
The questionnaire includes 7 items, grouped into two questions. Each item, is answered as either YES or NO.
A final cumulative patient's score is obtained by allocating 1 point for each YES and 0 point for each NO. If the patient's score ≥3/7, the test is positive.
This evaluation will be carried out only if the 11-point pain NRS ≥4/10.
Time Frame
At inclusion
Title
Neuropathic Pain Symptoms Inventory (NPSI)
Description
This self-reported questionnaire assesses different neuropathic pain symptoms. The French NPSI includes 12 items that discriminates and quantifies five distinct dimensions of neuropathic pain.
This evaluation will be carried out only if the 11-point pain NRS ≥4/10.
Time Frame
through study completion, an average of 4 months.
Title
Quality of Life Questionnaire-Cancer 30 (QLQ-C30)
Description
This EORTC self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
Time Frame
through study completion, an average of 4 months.
Title
Hospital Anxiety and Depression scale (HADS)
Description
This self-reported questionnaire permits to detect anxiety and depressive disorders. There are 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and 7 to the depressive dimension (total D), thus obtaining two scores (maximum score of each score = 21). To detect anxiety and depressive symptoms, the following interpretation is proposed for each of the scores (A and D):
≤7: absence of symptomatology
8 to 10: suspicious symptomatology
≥11: certain symptomatology
Time Frame
through study completion, an average of 4 months.
Title
Patients' Global Impression of Change (PGIC)
Description
PGIC is aimed at assessing the general effectiveness of the treatment. This scale consists of 7 level descriptors answering the question "How are you?" distributed in three ways: (i) improved (very/medium/slightly), (ii) unchanged and (iii) aggravated (slight/medium/very).
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis PEZET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital privé d'Antony
City
Antony
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Anne Thirot-Bidault
Facility Name
CH d'Argenteuil
City
Argenteuil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Malika BOUDRAOUI, MD
Facility Name
CHU de Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Christophe BORG
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Cédric Lecaille
Facility Name
Centre Hospitalier du Cotentin
City
Cherbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
First Name & Middle Initial & Last Name & Degree
Amr EL WESHI, MD
Facility Name
Centre Hospitalier Public du Cotentin
City
Cherbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Amr El Weshi
Facility Name
CH de Cholet
City
Cholet
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Victor Simmet
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Denis PEZET
Facility Name
Centre Hospitalier Compiègne-Noyon
City
Compiègne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Virginie SEBBAGH
Facility Name
Clinique de Flandre
City
Coudekerque-Branche
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Jean-Philippe WAGNER
Facility Name
CHU de Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Côme Lepage
Facility Name
Institut de Cancérologie de Bourgogne - GRReCC
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Ariane DARUT-JOUVE
Facility Name
CHD de Vendée
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Lucile BAUGUION
Facility Name
CH Le puy
City
Le Puy-en-Velay
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Brigitte Monange
Facility Name
Hôpital Franco-Britanique
City
Levallois-Perret
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Yosr BENROMDHANE
Facility Name
chu de Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Frédéric Thuillier
Facility Name
CH Saint Joseph Saint Luc
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Marc O'BRIEN, MD
Facility Name
Clinique de la sauvegarde
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Isabelle MOULLET, MD
Facility Name
Hôpital privé Jean Mermoz
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Jérôme DESRAME, MD
Facility Name
Hopital Saint Joseph de Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Hervé Perrier
Facility Name
Hôpital Européen de Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Yves Rinaldi
Facility Name
Groupe Hospitalier des Portes de Provence
City
Montélimar
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Ahmed AZZEDINE
Facility Name
Hôpital Saint-Louis - AP-HP
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Thomas APARICIO
Facility Name
Hôpital Privé des Cotes d'Armor
City
Plérin
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Jérôme MARTIN-BABAU, MD
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
David TOUGERON
Facility Name
Clinique La Croix du Sud
City
Quint-Fonsegrives
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lise Laclautre
First Name & Middle Initial & Last Name & Degree
Anne-Pascale Laurenty
Facility Name
CHU de Reims
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Olivier Bouche
Facility Name
Institut Godinot
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Damien Botsen
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Jean-Marc Phelip
Facility Name
Institut de Cancérologie Paris Nord
City
Sarcelles
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Julie Giroux
Facility Name
Groupe Hospitalier Saint Vincent - Clinique Saint Anne
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Louis-Marie DOURTHE
Facility Name
CHU de Bordeaux
City
Talence
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Denis Smith
Facility Name
Hôpital d'Instruction des Armées Sainte-Anne
City
Toulon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline PRIEUX-KLOTZ, MD
Facility Name
Hôpital d'Instruction des Armées Sainte-Anne
City
Toulon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Caroline Prieux-Klotz
Facility Name
CH de Valence
City
Valence
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Hélène Foisy
12. IPD Sharing Statement
Citations:
PubMed Identifier
35799138
Citation
Kerckhove N, Tougeron D, Lepage C, Pezet D, Le Malicot K, Pelkowski M, Pereira B, Balayssac D. Efficacy of donepezil for the treatment of oxaliplatin-induced peripheral neuropathy: DONEPEZOX, a protocol of a proof of concept, randomised, triple-blinded and multicentre trial. BMC Cancer. 2022 Jul 7;22(1):742. doi: 10.1186/s12885-022-09806-8.
Results Reference
derived
Learn more about this trial
Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study
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