Efficacy of Methylprednisolone on Pain, Fatigue, and Appetite Loss in Patients With Advanced Cancer Using Opioids: A Randomized, Placebo-Controlled, Double-Blind Trial

1. Ørnulf Paulsen⇑, 
2. Pål Klepstad, 
3. Jan Henrik Rosland, 
4. Nina Aass, 
5. Eva Albert,
6. Peter Fayers and 
7. Stein Kaasa

+Author Affiliations

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.

1. Corresponding author: Ørnulf Paulsen, MD, Telemark Hospital Trust, Palliative Care Unit, Ulefossveien, N-3710 Skien, Norway; e-mail: ornulf.paulsen@sthf.no.

1. Presented in abstract form and orally at the 13th World Congress of the European Association for Palliative Care, Prague, Czech Republic, May 30-June 2, 2013, and as a poster at the 2013 European Cancer Congress, Amsterdam, the Netherlands, September 28-October 1, 2013.

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, 1.19v 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.