A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors

被引:90
作者
Gewandter, Jennifer S. [1 ]
Mohile, Supriya G. [2 ]
Heckler, Charles E. [3 ]
Ryan, Julie L. [4 ]
Kirshner, Jeffrey J. [5 ]
Flynn, Patrick J. [6 ]
Hopkins, Judith O. [7 ]
Morrow, Gary R. [3 ]
机构
[1] Univ Rochester, Med Ctr, Dept Anesthesiol, Rochester, NY 14642 USA
[2] Univ Rochester, Med Ctr, Dept Med Hematol Oncol, Rochester, NY 14642 USA
[3] Univ Rochester, Med Ctr, Dept Radiat Oncol, Rochester, NY 14642 USA
[4] Univ Rochester, Med Ctr, Dept Dermatol, Rochester, NY 14642 USA
[5] Cent New York CCOP, Hematol Oncol Associates, E Syracuse, NY 13057 USA
[6] Metro Minnesota CCOP, Minneapolis, MN 55416 USA
[7] Piedmont HEM ONC Associates, Southeast Canc Control Consortium, Kernersville, NC 27284 USA
关键词
Chemotherapy-induced peripheral neuropathy; Ketamine; Amitriptyline; ACETYL-L-CARNITINE; DOUBLE-BLIND; CONTROLLED TRIAL; PAIN; COMBINATION; GLUTATHIONE; GABAPENTIN; PREVENTION; POLYNEUROPATHY; PREGABALIN;
D O I
10.1007/s00520-014-2158-7
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Chemotherapy-induced peripheral neuropathy (CIPN) occurs in as high as 70 % of patients receiving certain types of chemotherapy agents. The FDA has yet to approve a therapy for CIPN. The aim of this multicenter, phase III, randomized, double-blind, placebo-controlled trial was to investigate the efficacy of 2 % ketamine plus 4 % amitriptyline (KA) cream for reducing CIPN. Cancer survivors who completed chemotherapy at least 1 month prior and had CIPN (> 4 out of 10) were enrolled (N = 462). CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average "pain, numbness, or tingling in [their] hands and feet over the past 24 h" on an 11-point numeric rating scale at baseline and 6 weeks post intervention. ANCOVA was used to measure differences in 6-week CIPN with effects including baseline CIPN, KA treatment arm, and previous taxane therapy (Y/N). The KA treatment showed no effect on 6-week CIPN scores (adjusted mean difference = -0.17, p = 0.363). This study suggests that KA cream does not decrease CIPN symptoms in cancer survivors.
引用
收藏
页码:1807 / 1814
页数:8
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