Efficacy of interrupted cyclic treatment with prednisolone on cancer pain: a randomized crossover study

Abstract

Abstract Background Interrupted cyclic treatment with a low oral dose of prednisolone combined with stepladder analgesics would reduce the pain scores in cancer patients with reported less side effects. Following ethical approval, 39 cancer patients were randomized to receive prednisolone 10 mg every other day or every 4th day for 4 successive weeks followed with tapering prednisolone by 2.5 mg every 4 days over 2 weeks after each interval, primary outcome visual analog score (VAS), and other secondary outcomes such as (A) patient demographics; (B) pain scores; brief pain inventory score (BPI), pain severity score (PSS), pain interference score (PIS), analgesia level score, pain level score (PLS), and pain management index (PMI)); and (C) patient safety (adverse effects) with interrupted cyclic treatment with low-dose prednisolone. Results Compared with baseline values, patients had statistically significant lower VAS and PSS pain scores at 14 and 28 days after starting the 2 days cyclic treatment with prednisolone. Patients had comparative VAS and PSS pain scores during the 4-day cyclic treatment with prednisolone. Compared with the 4-day cyclic treatment, patients in the 2-day cyclic treatment had significant statistically lower VAS pain scores at 28 days. Adverse effects showed no significant statistical differences during both study sequences. Conclusion Interrupted cyclic prednisolone 10 mg combined with stepladder analgesic regimen is effective and safe in terms on improved quality of analgesia for 28 days in cancer patients more when used every 2nd day than every 4th day with appetite improvement during both. Trial registration The study protocol was approved by the local Institutional Board Review Committee on 8-11-2019. The study was prospectively registered with the www.clinicaltrials.gov