Evidence map›Paper›PMID 26644535›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

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

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

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Methadone versus other opioids for refractory malignant bone pain: a pilot randomised controlled study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. The Edmonton Classification System for Cancer Pain in Patients with Bone Metastasis: a descriptive cohort study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. The role of methadone in cancer-induced bone pain: a retrospective cohort study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Article
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Marie FallonMarie 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.
Peter J HoskinMarie 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.
Lesley A ColvinMarie 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.
Susan M Fleetwood-WalkerMarie 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.
Douglas AdamsonMarie 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.
Anthony ByrneMarie 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.
Gordon D MurrayMarie 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.
Barry J A LairdMarie 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.
Edinburgh Cancer Research · GB

Funding

Biotechnology and Biological Sciences Research Council BB/G002738/1Cancer Research UK A11922Cancer Research UK A7250Marie Curie MCCC-FCO-11-C
6 · The paper itself

Abstract

purposeCancer-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. PATIENTS AND

methodsA 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.

resultsA 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.

conclusionOur 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.

Indexed as

Activities of Daily LivingAdultAffectAgedAnalgesicsAnalgesics, OpioidBone and BonesBreakthrough PainChemoradiotherapyDouble-Blind MethodFemaleHumansMaleMiddle AgedNeoplasmsPain ManagementAnalgesicsAnalgesics, OpioidPregabalin

Identifiers

PMID26644535
PMCPMC5098845
OpenAlexW2190719547

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.