Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain.

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.

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.

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.

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.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2015 Dec 07 [Epub ahead of print] 

Marie Fallon, Peter J Hoskin, Lesley A Colvin, Susan M Fleetwood-Walker, Douglas Adamson, Anthony Byrne, Gordon D Murray, Barry J A Laird

PubMed

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. [email protected] ac. uk. , 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 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 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 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 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 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 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.