title: Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  N-methyl-D-aspartate receptor antagonists are potential therapies for neuropathic pain, and memantine has a good tolerance profile. A preclinical study recently reported that presurgery memantine may prevent neuropathic pain development and cognition dysfunction. Considering the high prevalence of breast cancer and of post-mastectomy neuropathic pain, a clinical trial is carried out to evaluate if memantine may prevent neuropathic pain development and maintain cognitive function and quality of life in cancer patients.
  
  
  METHODS
  A randomized clinical trial (NCT01536314) includes 40 women with breast cancer undergoing mastectomy at the Oncology Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) is administered for 4 weeks starting 2 weeks before surgery. Intensity of pain, cognitive function, quality of life and of sleep, anxiety and depression are evaluated with questionnaires. The primary endpoint is pain intensity on a 0 to 10) numerical scale at 3 months post-mastectomy. Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at α = 0.05.
  
  
  CONCLUSIONS
  The hypothesis of this translational approach is to confirm in patients the beneficial prophylactic effect of memantine observed in animals. Such a protective action of memantine against neuropathic pain and cognitive dysfunction would greatly improve the quality of life of cancer patients.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01536314 on 16 February 2012.
authors.affiliation: Clermont Université, Université d'Auvergne, Pharmacologie Fondamentale et Clinique de la Douleur, Laboratoire de Pharmacologie, Facultés de Médecine/Pharmacie, F-63000 Clermont-Ferrand, France. gisele.pickering@udamail.fr.
authors.forename: Gisèle
authors.initials: G
authors.lastname: Pickering
authors.forename: Véronique
authors.initials: V
authors.lastname: Morel
authors.forename: Dominique
authors.initials: D
authors.lastname: Joly
authors.forename: Christine
authors.initials: C
authors.lastname: Villatte
authors.forename: Delphine
authors.initials: D
authors.lastname: Roux
authors.forename: Claude
authors.initials: C
authors.lastname: Dubray
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
mesh_terms: D001943:Breast Neoplasms / Q000523:psychology / Q000601:surgery*; D002985:Clinical Protocols; D003072:Cognition Disorders / Q000517:prevention & control; D018691:Excitatory Amino Acid Antagonists / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008408:Mastectomy / Q000009:adverse effects*; D008559:Memantine / Q000627:therapeutic use*; D009437:Neuralgia / Q000517:prevention & control*; D010149:Postoperative Pain / Q000517:prevention & control*; D011788:Quality of Life; D016194:Receptors, N-Methyl-D-Aspartate / Q000037:antagonists & inhibitors*
chemical_list: D018691:Excitatory Amino Acid Antagonists; D016194:Receptors, N-Methyl-D-Aspartate; D008559:Memantine