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

Gisèle Pickering, Véronique Morel, Dominique Joly, Christine Villatte, Delphine Roux, Claude Dubray, Bruno Pereira, Gisèle Pickering, Véronique Morel, Dominique Joly, Christine Villatte, Delphine Roux, Claude Dubray, Bruno Pereira

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.

Figures

Figure 1
Figure 1
Study design.

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