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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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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.

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Acknowledgments

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.

Author information

Authors and Affiliations

  1. Department of Anesthesiology, University of Rochester Medical Center, 601 Elmwood Ave, Box 604, Rochester, NY, 14642, USA

    Jennifer S. Gewandter

  2. Department of Medicine, Hematology/Oncology, University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY, 14642, USA

    Supriya G. Mohile

  3. Department of Radiation Oncology, University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY, 14642, USA

    Charles E. Heckler & Gary R. Morrow

  4. Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY, 14642, USA

    Julie L. Ryan

  5. Hematology-Oncology Associates of Central New York CCOP, 5008 Brittonfield Parkway, East Syracuse, NY, 13057, USA

    Jeffrey J. Kirshner

  6. Metro Minnesota CCOP, 3800 Park Nicollet Blvd, St. Louis Park, MN, 55416, USA

    Patrick J. Flynn

  7. Southeast Cancer Control Consortium, Piedmont HEM/ONC Associates, 445 Pineview Dr. Suite 200, Kernersville, NC, 27284, USA

    Judith O. Hopkins

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  1. Jennifer S. Gewandter
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Corresponding author

Correspondence to Jennifer S. Gewandter.

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Clinical Trial Registration number: NCT00471445

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Gewandter, J.S., Mohile, S.G., Heckler, C.E. et al. 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. Support Care Cancer 22, 1807–1814 (2014). https://doi.org/10.1007/s00520-014-2158-7

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  • DOI: https://doi.org/10.1007/s00520-014-2158-7

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