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.
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