Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: a randomized, double-blind, placebo-controlled trial.
Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: a randomized, double-blind, placebo-controlled trial.
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DOI：
10.1007/s00520-013-2075-1
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发表时间：
2014-05
期刊：
影响因子：
--
通讯作者：
Fisch MJ
中科院分区：
文献类型：
--
作者：
Guo Y;Jones D;Palmer JL;Forman A;Dakhil SR;Velasco MR;Weiss M;Gilman P;Mills GM;Noga SJ;Eng C;Overman MJ;Fisch MJ
化疗诱导的周围神经病变通常是癌症治疗中的剂量限制因素，并可能导致癌症幸存者的疼痛和不可逆的功能丧失。我们测试了α-硫辛酸（ALA）是否可以降低接受铂类化疗患者周围神经病变症状的严重程度。18岁或以上的癌症患者被随机选择接受600 mg ALA或安慰剂，每日三次口服，持续24周，同时接受顺铂或奥沙利铂等化疗方案。通过癌症治疗功能评估/妇科肿瘤组-神经毒性（FACT/GOG-Ntx）量表和NCI不良事件神经毒性分级通用毒性标准测量神经病变。定时功能测试和简明疼痛量表（BPI）的结果是次要终点。243例患者中的70例（29%）完成了研究（24周）。ALA组和安慰剂组的脱落率相当。ALA组和安慰剂组的FACT/GOG-Ntx评分、BPI评分和患者功能结局无统计学显著性差异。这种口服ALA给药策略在预防奥沙利铂或顺铂引起的神经毒性方面无效。本试验中由于患者依从性差和给药方式导致的高损耗率表明该干预措施缺乏可行性。未来的研究，探索ALA作为一种神经保护剂应注意在这项研究中所面临的障碍。
Chemotherapy-induced peripheral neuropathy is frequently a dose-limiting factor in cancer treatment and may cause pain and irreversible function loss in cancer survivors. We tested whether alpha-lipoic acid (ALA) could decrease the severity of peripheral neuropathy symptoms in patients undergoing platinum-based chemotherapy. Cancer patients 18 years or older were randomly selected to receive either 600 mg ALA or a placebo three times a day orally for 24 weeks while receiving chemotherapy regimens including cisplatin or oxaliplatin. Neuropathy was measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale and the NCI Common Toxicity Criteria for Adverse Events neurotoxicity grades. Results from timed functional tests and the Brief Pain Inventory (BPI) were secondary endpoints. 70 of 243 (29%) patients completed the study (24 weeks). Both the ALA and the placebo arms had a comparable drop-out rate. No statistically significant differences were found between the ALA and the placebo groups for FACT/GOG-Ntx scores, BPI scores, and patients’ functional outcomes.. This strategy of oral ALA administration was ineffective at preventing neurotoxicity caused by oxaliplatin or cisplatin. High attrition rates due to poor patient compliance and manner of dosage administration in this trial demonstrated a lack of feasibility for this intervention. Future studies to explore ALA as a neuroprotective agent should take heed of the barriers confronted in this study.
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DOI：
10.1111/j.1525-1438.2003.13603.x
发表时间：
2003-11-01
影响因子：
4.8
作者：
Calhoun, EA;Welshman, EE;Cella, D
通讯作者：
Cella, D
DOI：
10.1111/j.1525-1438.2007.00794.x
发表时间：
2007-03-01
影响因子：
4.8
作者：
Huang, H. Q.;Brady, M. F.;Fleming, G.
通讯作者：
Fleming, G.
影响因子：
8.4
作者：
Albers, James W.;Chaudhry, Vinay;Cavaletti, Guido;Donehower, Ross C.
通讯作者：
Donehower, Ross C.
影响因子：
2.1
作者：
Argyriou, A. A.;Polychronopoulos, P.;Chroni, E.
通讯作者：
Chroni, E.
影响因子：
6.2
作者：
AARONSON, NK
通讯作者：
AARONSON, NK