Paulsen, O., Klepstad, P., Rosland, J.H., Aass, N., Albert, E., Fayers, P., & Kaasa, S. (2014). Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: A randomized, placebo-controlled, double-blind trial. Journal of Clinical Oncology. Advance online publication. 

To compare the analgesic efficacy of corticosteroid therapy versus a placebo

The intervention was methylprednisolone 32 mg daily for seven days. The research team used a computerized randomization program to assign participants to intervention or placebo groups. Randomization stratification was based on study center and verified pain related to bone metastases. Both the research team and study participants were blinded to study assignment. Pain intensity, fatigue, and appetite loss were measured at baseline and day 7. Analgesic use was recorded daily. Satisfaction with the intervention was measured at day 7. Semistructured interviews were conducted at day 7 to determine any adverse effects experienced by study participants.

• N = 49  
• MEAN AGE: 64 years
• MALES: 51%, FEMALES: 49% 
• KEY DISEASE CHARACTERISTICS: Cancer diagnoses were breast, prostate, gastrointestinal, lung, gynecologic, and “other.” All patients but one in each arm of the study had metastatic disease. Seven participants were receiving chemotherapy and six were receiving hormonal therapy; pain score > 4.
• OTHER KEY SAMPLE CHARACTERISTICS: Mean Karnofsky score was 62.5 (intervention group) and 66.0 (placebo group)

• SITE: Multi-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Norway

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

Placebo-controlled, double-blind, randomized controlled trial

• Brief Pain Inventory (BPI)
• Edmonton Symptom Assessment System (ESAS)
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ–C30)
• Satisfaction measured with intervention Numeric Rating Scale (NRS)
• Patient diary for recording daily analgesics
• Semistructured interviews

No significant difference was found between groups for average pain intensity at day 7, change in pain intensity from baseline, opioid intake, or adverse events. However, the intervention group did have a significant improvement in fatigue (p = .003) and appetite (p = .003) at day 7 compared to the placebo group. In addition, their overall satisfaction with treatment was also significantly greater (p = .001).

Pain relief was not improved for patients with advanced cancer who were taking on average a 222 mg oral morphine equivalent dose (MED). It is unknown whether this may be effective for different patient populations such as those taking a lower MED. Improvement in fatigue and appetite and a low number of adverse events were important clinical outcomes. Further study is needed to determine the long-term effects of this intervention.

• Small sample (< 100)
• Baseline sample/group differences of import
• Other limitations/explanation: Intervention group had a significantly higher dosage of MEDs compared to the control group

Nurses should be aware that methylprednisolone 32 mg daily may not be effective for improving pain relief in patients with advanced cancer who are taking an average opioid dose of ≥ 220 MED; however, it may improve fatigue and appetite with minimal adverse effects. Long-term effects have not yet been established. Long-term steroid use can contribute to other adverse side effects and should be weighed carefully with benefit of treatment.