title: Can pregabalin prevent paclitaxel-associated neuropathy?--An ACCRU pilot trial.
abstract: OBJECTIVE
  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(2)/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.
authors.affiliation: Department of Oncology, College of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Shivani S
authors.initials: SS
authors.lastname: Shinde
authors.affiliation: Department of Biostatistics, Mayo Clinic, Rochester, MN, USA.
authors.forename: Drew
authors.initials: D
authors.lastname: Seisler
authors.affiliation: Medical Oncology, Nebraska Cancer Specialists, Omaha, NE, USA.
authors.forename: Gamini
authors.initials: G
authors.lastname: Soori
authors.affiliation: Department of Biostatistics, Mayo Clinic, Rochester, MN, USA.
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Atherton
authors.affiliation: Department of Oncology, College of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Deirdre R
authors.initials: DR
authors.lastname: Pachman
authors.affiliation: Department of Oncology, College of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Lafky
authors.affiliation: Department of Oncology, College of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Kathryn J
authors.initials: KJ
authors.lastname: Ruddy
authors.affiliation: Department of Oncology, College of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. cloprinzi@mayo.edu.
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
mesh_terms: D059787:Acute Pain / Q000139:chemically induced / Q000517:prevention & control*; D000328:Adult; D000368:Aged; D000588:Amines / Q000627:therapeutic use; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use; D005260:Female; D000077206:Gabapentin; D006801:Humans; D006987:Hypesthesia / Q000139:chemically induced / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D017239:Paclitaxel / Q000009:adverse effects* / Q000627:therapeutic use; D010292:Paresthesia / Q000139:chemically induced / Q000517:prevention & control*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000517:prevention & control*; D010865:Pilot Projects; D010919:Placebos; D000069583:Pregabalin / Q000627:therapeutic use*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use
chemical_list: D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D010919:Placebos; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D017239:Paclitaxel
keywords: Chemotherapy-induced peripheral neuropathy; Paclitaxel-associated acute pain syndrome; Pregabalin; Prevention