Ornulf Paulsen1, Pål Klepstad2, Jan Henrik Rosland2, Nina Aass2, Eva Albert2, Peter Fayers2, Stein Kaasa2. 1. Ørnulf Paulsen, Telemark Hospital Trust, Skien; Ørnulf Paulsen, Pål Klepstad, Peter Fayers, and Stein Kaasa, Norwegian University of Science and Technology; Pål Klepstad and Stein Kaasa, St Olavs Hospital, Trondheim University Hospital, Trondheim; Jan Henrik Rosland, Haraldsplass Deaconess Hospital and University of Bergen, Bergen; Nina Aass, Oslo University Hospital and University of Oslo, Oslo; Eva Albert, Sørlandet Hospital Kristiansand, Kristiansand, Norway; and Peter Fayers, University of Aberdeen, Aberdeen, United Kingdom. ornulf.paulsen@sthf.no. 2. Ørnulf Paulsen, Telemark Hospital Trust, Skien; Ørnulf Paulsen, Pål Klepstad, Peter Fayers, and Stein Kaasa, Norwegian University of Science and Technology; Pål Klepstad and Stein Kaasa, St Olavs Hospital, Trondheim University Hospital, Trondheim; Jan Henrik Rosland, Haraldsplass Deaconess Hospital and University of Bergen, Bergen; Nina Aass, Oslo University Hospital and University of Oslo, Oslo; Eva Albert, Sørlandet Hospital Kristiansand, Kristiansand, Norway; and Peter Fayers, University of Aberdeen, Aberdeen, United Kingdom.
Abstract
PURPOSE:Corticosteroids are frequently used in cancer pain management despite limited evidence. This study compares the analgesic efficacy of corticosteroid therapy with placebo. PATIENTS AND METHODS: Adult patients with cancer receiving opioids with average pain intensity ≥ 4 (numeric rating scale [NRS], 0 to 10) in the last 24 hours were eligible. Patients were randomly assigned to methylprednisolone (MP) 16 mg twice daily or placebo (PL) for 7 days. Primary outcome was average pain intensity measured at day 7 (NRS, 0 to 10); secondary outcomes were analgesic consumption (oral morphine equivalents), fatigue and appetite loss (European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire C30, 0 to 100), and patient satisfaction (NRS, 0 to 10). RESULTS:A total of 592 patients were screened; 50 were randomly assigned, and 47 were analyzed. Baseline opioid level was 269.9 mg in the MP arm and 160.4 mg in the PL arm. At day-7 evaluation, there was no difference between the groups in pain intensity (MP, 3.60 v PL, 3.68; P = .88) or relative analgesic consumption (MP, 1.19 v PL, 1.20; P = .95). Clinically and statistically significant improvements were found in fatigue (-17 v 3 points; P .003), appetite loss (-24 v 2 points; P = .003), and patient satisfaction (5.4 v 2.0 points; P = .001) in favor of the MP compared with the PL group, respectively. There were no differences in adverse effects between the groups. CONCLUSION: MP 32 mg daily did not provide additional analgesia in patients with cancer receiving opioids, but it improved fatigue, appetite loss, and patient satisfaction. Clinical benefit beyond a short-term effect must be examined in a future study.
RCT Entities:
PURPOSE: Corticosteroids are frequently used in cancer pain management despite limited evidence. This study compares the analgesic efficacy of corticosteroid therapy with placebo. PATIENTS AND METHODS: Adult patients with cancer receiving opioids with average pain intensity ≥ 4 (numeric rating scale [NRS], 0 to 10) in the last 24 hours were eligible. Patients were randomly assigned to methylprednisolone (MP) 16 mg twice daily or placebo (PL) for 7 days. Primary outcome was average pain intensity measured at day 7 (NRS, 0 to 10); secondary outcomes were analgesic consumption (oral morphine equivalents), fatigue and appetite loss (European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire C30, 0 to 100), and patient satisfaction (NRS, 0 to 10). RESULTS: A total of 592 patients were screened; 50 were randomly assigned, and 47 were analyzed. Baseline opioid level was 269.9 mg in the MP arm and 160.4 mg in the PL arm. At day-7 evaluation, there was no difference between the groups in pain intensity (MP, 3.60 v PL, 3.68; P = .88) or relative analgesic consumption (MP, 1.19 v PL, 1.20; P = .95). Clinically and statistically significant improvements were found in fatigue (-17 v 3 points; P .003), appetite loss (-24 v 2 points; P = .003), and patient satisfaction (5.4 v 2.0 points; P = .001) in favor of the MP compared with the PL group, respectively. There were no differences in adverse effects between the groups. CONCLUSION:MP 32 mg daily did not provide additional analgesia in patients with cancer receiving opioids, but it improved fatigue, appetite loss, and patient satisfaction. Clinical benefit beyond a short-term effect must be examined in a future study.
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Authors: Ann M Berger; Kathi Mooney; Amy Alvarez-Perez; William S Breitbart; Kristen M Carpenter; David Cella; Charles Cleeland; Efrat Dotan; Mario A Eisenberger; Carmen P Escalante; Paul B Jacobsen; Catherine Jankowski; Thomas LeBlanc; Jennifer A Ligibel; Elizabeth Trice Loggers; Belinda Mandrell; Barbara A Murphy; Oxana Palesh; William F Pirl; Steven C Plaxe; Michelle B Riba; Hope S Rugo; Carolina Salvador; Lynne I Wagner; Nina D Wagner-Johnston; Finly J Zachariah; Mary Anne Bergman; Courtney Smith Journal: J Natl Compr Canc Netw Date: 2015-08 Impact factor: 11.908
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Authors: David Hui; Kelly Kilgore; Susan Frisbee-Hume; Minjeong Park; Anne Tsao; Marvin Delgado Guay; Charles Lu; William William; Katherine Pisters; George Eapen; Frank Fossella; Sapna Amin; Eduardo Bruera Journal: J Pain Symptom Manage Date: 2016-06-18 Impact factor: 3.612