Abstract
Purpose
Refractory cancer-induced bone pain (CIBP) affects a patient’s functional capacity and quality of life, but there is limited evidence to guide opioid choice. We assessed the feasibility, tolerability, and possible efficacy of methadone rotation (MR) compared to other opioid rotations (OOR) in this cohort.
Methods
Adults with CIBP and worst pain intensity ≥ 4/10 and/or opioid toxicity graded ≥ 2 on the Common Terminology Criteria for Adverse Events were randomised 1:1 to methadone or another opioid rotation. Standardised assessment tools were used at pre-defined study time points up to fourteen days.
Results
From 51 eligible participants, 38 (74.5%) consented, and 29 (76.3%, MR: 14, OOR: 15) completed the fourteen days follow up post opioid rotation. Both groups displayed significant reduction in average (MR: d= -1.2, p = 0.003, OOR: d= -0.8, p = 0.015) and worst pain (MR: d= -0.9, p = 0.042, OOR: d= -0.6, p = 0.048), and total pain interference score (MR: d=-1.1, p = 0.042, OOR: d=-0.7, p = 0.007). Oral morphine equivalent daily dose reduced significantly in MR compared to OOR group (d= -0.8, p = 0.05). The incidence of opioid related adverse event following MR was unchanged but lower in the OOR group (d = 0.9, 95% CI 0.1,1.7, p = 0.022). There was no within group or between group differences in satisfaction with analgesia at the end of the study.
Conclusion
This pilot study demonstrated that MR and OOR in patients with refractory CIBP are feasible, safe, and acceptable to patients. Appropriately powered multi-centre randomised controlled studies are needed to confirm the efficacy of MR and OOR in this cohort.
Trial registration number
ACTRN12621000141842 registered 11 February 2021.