Prophylaxis of Neuropathic Pain by mémantine

Study Overview
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Brief Summary
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The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.

Detailed Description
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The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.

Official Title
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Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: Memantine EBIXA®
* Drug: Placebo : lactose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old patient suffering breast cancer with mastectomy/tumorectomy with or within cleaning 2 weeks after inclusion with or within pre-emptive chemotherapy Exclusion Criteria: Against-indication at memantine administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency Diabetic patient (Type I and II) Patient with medical or surgical antecedents Patient receiving treatment with amantadine, ketamine, dextrometorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbiturate, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenitoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine Patient with alcohol addiction Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Memantine EBIXA®|The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.|
|Drug: Placebo : lactose|The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average painful intensity |  | 5 days before visit of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain by numerical scale |  | during 15 first days following surgery and to visit of 3 months | 
| Average painful |  | on 5 days before visit of 6 months post-surgery | 
| analgesic consumption |  | during 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-emptive administration, Post-operative administration, Prophylaxis, Memantine, Post-mastectomy/tumorectomy, Neuropathic pain