title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  The KA treatment showed no effect on 6-week CIPN scores (adjusted mean difference=-0.17, p=0.363).
  
  
  CONCLUSIONS
  This study suggests that KA cream does not decrease CIPN symptoms in cancer survivors.
authors: Department of Anesthesiology, University of Rochester Medical Center, 601 Elmwood Ave, Box 604, Rochester, NY, 14642, USA, jennifer_gewandter@urmc.rochester.edu.
authors: Jennifer S
authors: JS
authors: Gewandter
authors: Supriya G
authors: SG
authors: Mohile
authors: Charles E
authors: CE
authors: Heckler
authors: Julie L
authors: JL
authors: Ryan
authors: Jeffrey J
authors: JJ
authors: Kirshner
authors: Patrick J
authors: PJ
authors: Flynn
authors: Judith O
authors: JO
authors: Hopkins
authors: Gary R
authors: GR
authors: Morrow
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000639:Amitriptyline / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007649:Ketamine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D020258:Neurotoxicity Syndromes / Q000188:drug therapy* / Q000209:etiology; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000639:Amitriptyline; D007649:Ketamine