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

Shivani S. Shinde, Drew Seisler, Gamini Soori, Pamela J. Atherton, Deirdre R. Pachman, Jacqueline Lafky, Kathryn J Ruddy, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

22 Citations (Scopus)

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/m<sup>2</sup>/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.

Original languageEnglish (US)
JournalSupportive Care in Cancer
DOIs
StateAccepted/In press - Jul 9 2015

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Paclitaxel
Acute Pain
Peripheral Nervous System Diseases
Drug Therapy
Placebos
Hypesthesia
Pregabalin
Therapeutics
Quality of Life
Organizations
Pain
Research
Surveys and Questionnaires
Neoplasms

Keywords

  • Chemotherapy-induced peripheral neuropathy
  • Paclitaxel-associated acute pain syndrome
  • Pregabalin
  • Prevention

ASJC Scopus subject areas

  • Oncology

Cite this

Can pregabalin prevent paclitaxel-associated neuropathy?—An ACCRU pilot trial. / Shinde, Shivani S.; Seisler, Drew; Soori, Gamini; Atherton, Pamela J.; Pachman, Deirdre R.; Lafky, Jacqueline; Ruddy, Kathryn J; Loprinzi, Charles Lawrence.

In: Supportive Care in Cancer, 09.07.2015.

Research output: Contribution to journalArticle

Shinde, Shivani S. ; Seisler, Drew ; Soori, Gamini ; Atherton, Pamela J. ; Pachman, Deirdre R. ; Lafky, Jacqueline ; Ruddy, Kathryn J ; Loprinzi, Charles Lawrence. / Can pregabalin prevent paclitaxel-associated neuropathy?—An ACCRU pilot trial. In: Supportive Care in Cancer. 2015.
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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.",
keywords = "Chemotherapy-induced peripheral neuropathy, Paclitaxel-associated acute pain syndrome, Pregabalin, Prevention",
author = "Shinde, {Shivani S.} and Drew Seisler and Gamini Soori and Atherton, {Pamela J.} and Pachman, {Deirdre R.} and Jacqueline Lafky and Ruddy, {Kathryn J} and Loprinzi, {Charles Lawrence}",
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AU - Shinde, Shivani S.

AU - Seisler, Drew

AU - Soori, Gamini

AU - Atherton, Pamela J.

AU - Pachman, Deirdre R.

AU - Lafky, Jacqueline

AU - Ruddy, Kathryn J

AU - Loprinzi, Charles Lawrence

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N2 - 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.

AB - 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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KW - Paclitaxel-associated acute pain syndrome

KW - Pregabalin

KW - Prevention

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