Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: a randomized, placebo-controlled, double-blind trial
- PMID: 25002731
- DOI: 10.1200/JCO.2013.54.3926
Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: a randomized, placebo-controlled, double-blind trial
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.
© 2014 by American Society of Clinical Oncology.
Comment in
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Are corticosteroids effective in all patients with cancer-related pain?J Clin Oncol. 2014 Oct 10;32(29):3210-1. doi: 10.1200/JCO.2014.56.7701. Epub 2014 Sep 15. J Clin Oncol. 2014. PMID: 25225427 No abstract available.
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Reply to a. Molfino et Al.J Clin Oncol. 2015 May 1;33(13):1513. doi: 10.1200/JCO.2014.60.6475. Epub 2015 Mar 9. J Clin Oncol. 2015. PMID: 25753433 No abstract available.
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Anorexia assessment in patients with cancer: a crucial issue to improve the outcome.J Clin Oncol. 2015 May 1;33(13):1513. doi: 10.1200/JCO.2014.59.9548. Epub 2015 Mar 9. J Clin Oncol. 2015. PMID: 25753439 No abstract available.
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