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Open Access Study protocol

Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial

Gisèle Pickering123*, Véronique Morel123, Dominique Joly4, Christine Villatte4, Delphine Roux3, Claude Dubray123 and Bruno Pereira5

Author Affiliations

1 Clermont Université, Université d’Auvergne, Pharmacologie Fondamentale et Clinique de la Douleur, Laboratoire de Pharmacologie, Facultés de Médecine/Pharmacie, F-63000 Clermont-Ferrand, France

2 Inserm, U1107 Neuro-Dol, F-63001 Clermont-Ferrand, France

3 CHU Clermont-Ferrand, Inserm CIC 1405, Centre de Pharmacologie Clinique, F-63003 Clermont-Ferrand, France

4 CHU Clermont-Ferrand, Centre Jean Perrin, Centre de Lutte contre le Cancer, 58 rue Montalembert, F-63000 Clermont-Ferrand, France

5 CHU de Clermont-Ferrand, Délégation Recherche Clinique & Innovation - Villa annexe IFSI, 58 Rue Montalembert, F-63003 Clermont-Ferrand cedex, France

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Trials 2014, 15:331  doi:10.1186/1745-6215-15-331

Published: 20 August 2014

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/Design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov: NCT01536314 on 16 February 2012

Keywords:
Memantine; NMDA receptor; Breast cancer; Mastectomy; Chemotherapy; Neuropathic pain