title: Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain.
abstract: OBJECTIVE
  Cancer-induced bone pain (CIBP) affects one third of patients with cancer. Radiotherapy remains the gold-standard treatment; however, laboratory and clinical work suggest that pregabalin may be useful in treating CIBP. The aim of this study was to examine pregabalin in patients with CIBP receiving radiotherapy.
  
  
  METHODS
  A multicenter, double-blind randomized trial of pregabalin versus placebo was conducted. Eligible patients were age ≥ 18 years, had radiologically proven bone metastases, were scheduled to receive radiotherapy, and had pain scores ≥ 4 of 10 (on 0-to-10 numeric rating scale). Before radiotherapy, baseline assessments were completed, followed by random assignment. Doses of pregabalin and placebo were increased over 4 weeks. The primary end point was treatment response, defined as a reduction of ≥ 2 points in worst pain by week 4, accompanied by a stable or reduced opioid dose, compared with baseline. Secondary end points assessed average pain, interference of pain with activity, breakthrough pain, mood, quality of life, and adverse events.
  
  
  RESULTS
  A total of 233 patients were randomly assigned: 117 to placebo and 116 to pregabalin. The most common cancers were prostate (n = 88; 38%), breast (n = 77; 33%), and lung (n = 42; 18%). In the pregabalin arm, 45 patients (38.8%) achieved the primary end point, compared with 47 (40.2%) in the placebo arm (adjusted odds ratio, 1.07; 95% CI, 0.63 to 1.81; P = .816). There were no statistically significant differences in average pain, pain interference, or quality of life between arms. There were differences in mood (P = .031) and breakthrough pain duration (P = .037) between arms. Outcomes were compared at 4 weeks.
  
  
  CONCLUSIONS
  Our findings do not support the role of pregabalin in patients with CIBP receiving radiotherapy. The role of pregabalin in CIBP with a clinical neuropathic pain component is unknown.
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway. marie.fallon@ed.ac.uk.
authors.forename: Marie
authors.initials: M
authors.lastname: Fallon
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Hoskin
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Lesley A
authors.initials: LA
authors.lastname: Colvin
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Fleetwood-Walker
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Douglas
authors.initials: D
authors.lastname: Adamson
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Anthony
authors.initials: A
authors.lastname: Byrne
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Gordon D
authors.initials: GD
authors.lastname: Murray
authors.affiliation: Marie Fallon and Barry J.A. Laird, Edinburgh Cancer Research Centre, University of Edinburgh; Lesley A. Colvin, Western General Hospital and University of Edinburgh; Susan M. Fleetwood-Walker, School of Biomedical Sciences, University of Edinburgh; Gordon D. Murray, Centre for Population Health Sciences, University of Edinburgh, Edinburgh; Peter J. Hoskin, Mount Vernon Hospital Cancer Centre, Middlesex, and University College London; Douglas Adamson, Princess Alexandra Centre, Ninewells Hospital, Dundee; Anthony Byrne, Marie Curie Palliative Care Research Centre, Institute of Cancer and Genetics, Cardiff University, Cardiff, United Kingdom; and Barry J.A. Laird, European Palliative Care Research Centre, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Barry J A
authors.initials: BJ
authors.lastname: Laird
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000339:Affect; D000368:Aged; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000627:therapeutic use; D001842:Bone and Bones; D059390:Breakthrough Pain / Q000209:etiology / Q000628:therapy*; D059248:Chemoradiotherapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement; D010166:Palliative Care / Q000379:methods*; D000069583:Pregabalin / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life
chemical_list: D000700:Analgesics; D000701:Analgesics, Opioid; D000069583:Pregabalin