Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: A randomized, placebo-controlled, double-blind trial

Ørnulf Paulsen* (Corresponding Author), Pål Klepstad, Jan Henrik Rosland, Nina Aass, Eva Albert, Peter Fayers, Stein Kaasa

*Corresponding author for this work

Research output: Contribution to journalArticle

68 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)3221-3228
Number of pages8
JournalJournal of Clinical Oncology
Volume32
Issue number29
DOIs
Publication statusPublished - 10 Oct 2014

Fingerprint

Methylprednisolone
Appetite
Opioid Analgesics
Fatigue
Placebos
Pain
Patient Satisfaction
Analgesics
Neoplasms
Pain Management
Analgesia
Morphine
Adrenal Cortex Hormones
Therapeutics
Research

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids : A randomized, placebo-controlled, double-blind trial. / Paulsen, Ørnulf (Corresponding Author); Klepstad, Pål; Rosland, Jan Henrik; Aass, Nina; Albert, Eva; Fayers, Peter; Kaasa, Stein.

In: Journal of Clinical Oncology, Vol. 32, No. 29, 10.10.2014, p. 3221-3228.

Research output: Contribution to journalArticle

Paulsen, Ørnulf ; Klepstad, Pål ; Rosland, Jan Henrik ; Aass, Nina ; Albert, Eva ; Fayers, Peter ; Kaasa, Stein. / Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids : A randomized, placebo-controlled, double-blind trial. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 29. pp. 3221-3228.
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title = "Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: A randomized, placebo-controlled, double-blind trial",
abstract = "PurposeCorticosteroids 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.",
author = "{\O}rnulf Paulsen and P{\aa}l Klepstad and Rosland, {Jan Henrik} and Nina Aass and Eva Albert and Peter Fayers and Stein Kaasa",
note = "Supported by unrestricted grants from the Telemark Hospital Trust and the South-Eastern Norway Regional Health Authority. We thank Sebastian von Hofacker, Arve Nordb{\o}, Frode Skanke, Erik Hellem, Katrin Rut Sigurdardottir, and Morten Thron{\ae}s (site investigators who recruited patients and gathered data); Marianne Aamand and Ragnhild Thormodsr{\o}d (coordinating study nurses who performed follow-up at study centers); Grethe Skorpen Iversen, Bente Elisabeth Marum, Bente Miriam Christiansen, Cinzia Marini, Torbj{\o}rn {\O}vreness, and Ingunn Eriksen (study nurses); Karin Tulluan and Marianne Bjelk{\aa}sen (randomization); Gunnhild Jacobsen (assistance with database design and SPSS statistical software); Lone Nielsen (pharmacist); and staff and patients for participation.",
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T1 - Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids

T2 - A randomized, placebo-controlled, double-blind trial

AU - Paulsen, Ørnulf

AU - Klepstad, Pål

AU - Rosland, Jan Henrik

AU - Aass, Nina

AU - Albert, Eva

AU - Fayers, Peter

AU - Kaasa, Stein

N1 - 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.

PY - 2014/10/10

Y1 - 2014/10/10

N2 - PurposeCorticosteroids 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.

AB - PurposeCorticosteroids 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.

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DO - 10.1200/JCO.2013.54.3926

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JO - Journal of Clinical Oncology

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