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
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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.
KeywordsChemotherapy-induced peripheral neuropathy Ketamine Amitriptyline
We thank the patients, clinicians and researchers of the University of Rochester Community Clinical Oncology Program who contributed to this study. Epicept provided the drug and placebo creams. This work was funded by the National Cancer Institute (U10CA37420).
Conflict of interest
The authors have no conflicts of interest to discuss.
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