Morel Véronique, Joly Dominique, Villatte Christine, Pereira Bruno, Pickering Gisèle
CHU Clermont-Ferrand, Inserm CIC Inserm 1405, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.
CHU Clermont-Ferrand, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, Auvergne, France.
BMJ Open. 2018 Oct 4;8(9):e017986. doi: 10.1136/bmjopen-2017-017986.
Breast cancer affects 1 in 10 women worldwide, and mastectomy is a cause of chronic pain with neuropathic characteristics. -methyl-D-aspartate receptor (NMDAR) antagonists such as ketamine, memantine, dextromethorphan or magnesium are used to treat refractory pain by blocking NMDAR. Oral memantine has been shown to prevent postmastectomy pain and cognitive impact and to maintain quality of life. Likewise, the present study is intended to assess the preventive effect of oral magnesium, administered ahead of mastectomy, on the development of neuropathic pain. As a physiological blocker of NMDAR, magnesium could be an interesting candidate to prevent postoperative pain and associated comorbidities, including cognitive and emotional disorders, multiple analgesic consumption and impaired quality of life.
A randomised double-blind controlled clinical trial (NCT03063931) will include 100 women with breast cancer undergoing mastectomy at the Oncology Hospital, Clermont-Ferrand, France. Magnesium (100 mg/day; n=50) or placebo (n=50) will be administered for 6 weeks, starting 2 weeks before surgery. Intensity of pain, cognitive and emotional function and quality of life will be assessed by questionnaires. The primary endpoint is pain intensity on a 0-10 numerical rating scale at 1 month postmastectomy. Data analysis will use mixed models; all tests will be two-tailed, with type-I error set at α=0.05.
The study protocol and informed consent form were approved in December 2016 by the French Research Ethics Committee (South East VI Committee). Results will be communicated in various congresses and published in international publications.
NCT03063931.
全球每10名女性中就有1人受乳腺癌影响，乳房切除术是导致具有神经病理性特征的慢性疼痛的一个原因。N-甲基-D-天冬氨酸受体（NMDAR）拮抗剂，如氯胺酮、美金刚、右美沙芬或镁，可通过阻断NMDAR来治疗难治性疼痛。口服美金刚已被证明可预防乳房切除术后疼痛和认知影响，并维持生活质量。同样，本研究旨在评估乳房切除术前行口服镁对神经性疼痛发生的预防作用。作为NMDAR的生理性阻滞剂，镁可能是预防术后疼痛及相关合并症（包括认知和情绪障碍、多种镇痛药物使用及生活质量受损）的一个有吸引力的候选药物。
一项随机双盲对照临床试验（NCT03063931）将纳入100例在法国克莱蒙费朗肿瘤医院接受乳房切除术的乳腺癌女性患者。镁（100毫克/天；n = 50）或安慰剂（n = 50）将在手术前2周开始服用，持续6周。疼痛强度、认知和情绪功能以及生活质量将通过问卷进行评估。主要终点是乳房切除术后1个月时采用0至10数字评分量表评估的疼痛强度。数据分析将使用混合模型；所有检验均为双侧检验，I型错误设定为α = 0.05。
研究方案和知情同意书于2016年12月获得法国研究伦理委员会（东南部第六委员会）批准。研究结果将在各种大会上交流，并发表在国际出版物上。
NCT0306393
