Abstract
BackgroundN-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/DesignA 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.DiscussionThe 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 registrationClinicalTrials.gov: NCT01536314 on 16 February 2012
Highlights
N-methyl-D-aspartate receptor antagonists are potential therapies for neuropathic pain, and memantine has a good tolerance profile
Such a protective action of memantine against neuropathic pain and cognitive dysfunction would greatly improve the quality of life of cancer patients
N-methyl-D-aspartate receptor (NMDAR) antagonists, such as ketamine [6,7], are prescribed after therapeutic failure with classical treatment but these drugs have severe adverse events that limit their clinical use [8]. Another NMDAR antagonist, memantine, prescribed in Alzheimer’s disease to maintain cognitive function, has minimal side-effects at doses within the therapeutic range, probably because of its specific mechanism of action as it is an uncompetitive antagonist with moderate affinity, strong voltage-dependency and rapid unblocking kinetics [9,10,11]
Summary
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. N-methyl-D-aspartate receptor (NMDAR) antagonists such as ketamine, memantine or dextromethorphan are potential drugs for NP alleviation [2]. Confirmation of preclinical results in this clinical study would constitute a major step for NP prevention by memantine and maintenance of cognition and quality of life in these vulnerable patients
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