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.

Author(s): Gewandter JS(1), Mohile SG, Heckler CE, Ryan JL, Kirshner JJ, Flynn PJ, Hopkins JO, Morrow GR.

Affiliation(s): Author information: (1)Department of Anesthesiology, University of Rochester Medical Center, 601 Elmwood Ave, Box 604, Rochester, NY, 14642, USA, jennifer_gewandter@urmc.rochester.edu.

Publication date & source: 2014, Support Care Cancer. , 22(7):1807-14

PURPOSE: 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.