Supportive Care in Cancer

, Volume 22, Issue 7, pp 1807–1814

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

  • Jennifer S. Gewandter
  • Supriya G. Mohile
  • Charles E. Heckler
  • Julie L. Ryan
  • Jeffrey J. Kirshner
  • Patrick J. Flynn
  • Judith O. Hopkins
  • Gary R. Morrow
Original Article

DOI: 10.1007/s00520-014-2158-7

Cite this article as:
Gewandter, J.S., Mohile, S.G., Heckler, C.E. et al. Support Care Cancer (2014) 22: 1807. doi:10.1007/s00520-014-2158-7

Abstract

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.

Keywords

Chemotherapy-induced peripheral neuropathyKetamineAmitriptyline

Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Jennifer S. Gewandter
    • 1
  • Supriya G. Mohile
    • 2
  • Charles E. Heckler
    • 3
  • Julie L. Ryan
    • 4
  • Jeffrey J. Kirshner
    • 5
  • Patrick J. Flynn
    • 6
  • Judith O. Hopkins
    • 7
  • Gary R. Morrow
    • 3
  1. 1.Department of AnesthesiologyUniversity of Rochester Medical CenterRochesterUSA
  2. 2.Department of Medicine, Hematology/OncologyUniversity of Rochester Medical CenterRochesterUSA
  3. 3.Department of Radiation OncologyUniversity of Rochester Medical CenterRochesterUSA
  4. 4.Department of DermatologyUniversity of Rochester Medical CenterRochesterUSA
  5. 5.Hematology-Oncology Associates of Central New York CCOPEast SyracuseUSA
  6. 6.Metro Minnesota CCOPSt. Louis ParkUSA
  7. 7.Southeast Cancer Control Consortium, Piedmont HEM/ONC AssociatesKernersvilleUSA