Abstract
Corticosteroids are frequently used in cancer pain management despite limited evidence. This study compares the analgesic efficacy of corticosteroid therapy with placebo.
Patients and MethodsAdult 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).
ResultsA 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.
ConclusionMP 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.
| Original language | English |
|---|---|
| Pages (from-to) | 3221-3228 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 32 |
| Issue number | 29 |
| DOIs | |
| Publication status | Published - 10 Oct 2014 |
Bibliographical note
Supported by unrestricted grants from the Telemark Hospital Trust and the South-Eastern Norway Regional Health Authority.We thank Sebastian von Hofacker, Arve Nordbø, Frode Skanke, Erik Hellem, Katrin Rut Sigurdardottir, and Morten Thronæs (site investigators who recruited patients and gathered data); Marianne Aamand and Ragnhild Thormodsrød (coordinating study nurses who performed follow-up at study centers); Grethe Skorpen Iversen, Bente Elisabeth Marum, Bente Miriam Christiansen, Cinzia Marini, Torbjørn Øvreness, and Ingunn Eriksen (study nurses); Karin Tulluan and Marianne Bjelkåsen (randomization); Gunnhild Jacobsen (assistance with database design and SPSS statistical software); Lone Nielsen (pharmacist); and staff and patients for participation.
