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  • 标题:Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial
  • 本地全文:下载
  • 作者:Gisèle Pickering ; Véronique Morel ; Dominique Joly
  • 期刊名称:Trials
  • 印刷版ISSN:1745-6215
  • 电子版ISSN:1745-6215
  • 出版年度:2014
  • 卷号:15
  • 期号:1
  • 页码:331
  • DOI:10.1186/1745-6215-15-331
  • 语种:English
  • 出版社:BioMed Central
  • 摘要: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. 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. 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. ClinicalTrials.gov: NCT01536314 on 16 February 2012
  • 关键词:Memantine ; NMDA receptor ; Breast cancer ; Mastectomy ; Chemotherapy ; Neuropathic pain
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