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Can pregabalin prevent paclitaxel-associated neuropathy?—An ACCRU pilot trial

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Supportive Care in Cancer Aims and scope Submit manuscript

Abstract

Purpose

Paclitaxel can cause an acute pain syndrome (P-APS), considered to be an acute form of neuropathy and chronic chemotherapy-induced peripheral neuropathy (CIPN). Anecdotal reports suggested that gabapentin may be helpful in the prevention of these toxicities. The purpose of this pilot study was to obtain data to support or refute the utility of pregabalin for the prevention of P-APS and CIPN.

Methods

Patients scheduled to receive weekly paclitaxel (80 mg/m2/dose) were randomized 1:1 to receive pregabalin 75 mg or a placebo, twice daily, during the 12 weeks of chemotherapy. Patients completed the European Organization of Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20 questionnaire at baseline, prior to each dose of paclitaxel and monthly for 6 months post-treatment. Patients completed a post-paclitaxel questionnaire for 6 days after each dose of paclitaxel and an acute pain syndrome symptom questionnaire on day 8. The primary end point was to determine the effect of pregabalin on the maximum of the worst acute pain scores for the week following paclitaxel administration for cycle 1.

Results

Forty-six patients were randomly assigned to the treatment or placebo arm. There was no suggestion of a difference between the two study arms with regard to P-APS measures. While there was a suggestion that pregabalin decreased numbness, there was no suggestion that it decreased tingling, pain, or the EORTC QLQ-CIPN20 subscale scores. There were no evident toxicity differences between the two study arms.

Conclusions

The results of this pilot trial do not support that pregabalin is helpful for preventing P-APS or paclitaxel-associated CIPN.

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Acknowledgments

This project was funded by Pfizer and conducted by the Academic and Community Research United (ACCRU) group.

Conflict of interest

Pfizer funded this study but had no input into the writing of this manuscript. We have control of the primary data, which are available to the journal to review, if indicated.

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Authors and Affiliations

  1. Department of Oncology, College of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA

    Shivani S. Shinde, Deirdre R. Pachman, Jacqueline Lafky, Kathryn J. Ruddy & Charles L. Loprinzi

  2. Department of Biostatistics, Mayo Clinic, Rochester, MN, USA

    Drew Seisler & Pamela J. Atherton

  3. Medical Oncology, Nebraska Cancer Specialists, Omaha, NE, USA

    Gamini Soori

Authors
  1. Shivani S. Shinde
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  2. Drew Seisler
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  3. Gamini Soori
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  4. Pamela J. Atherton
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  5. Deirdre R. Pachman
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  6. Jacqueline Lafky
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  7. Kathryn J. Ruddy
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  8. Charles L. Loprinzi
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Corresponding author

Correspondence to Charles L. Loprinzi.

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Shinde, S.S., Seisler, D., Soori, G. et al. Can pregabalin prevent paclitaxel-associated neuropathy?—An ACCRU pilot trial. Support Care Cancer 24, 547–553 (2016). https://doi.org/10.1007/s00520-015-2807-5

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  • DOI: https://doi.org/10.1007/s00520-015-2807-5

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