CompletedPhase 3

Prophylaxis of Neuropathic Pain by mémantine

France43 participantsStarted 2012-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

average painful intensity

Timeframe: 5 days before visit of 3 months

Trial details

NCT IDNCT01536314

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Neuropathic Pain trials