Moukharskaya, J., Abrams, D.M., Ashikaga, T., Khan, F., Schwartz, J., Wilson, K., . . . Ades, S. (2016). Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim. Supportive Care in Cancer, 24, 3085–3093.
To investigate the effects of prophylactic antihistamine on colony-stimulating factor(CSF)–related bone pain
The study included observation and treatment phases. Patients receiving pegfilgrastim completed pain surveys during the observation phase. Patients who developed significant pain were randomized to loratadine 10 mg daily or a matched placebo for seven days beginning on the day of pegfilgrastim administration. Rescue analgesics were recorded. Bone pain was assessed at baseline and on day 8 during both study phases.
Significant bone pain occurred in 30.5% of patients and worst pain score increased on average from 1.6 to 3.6 during the eight days following pegfilgrastim (p < 0.001). Patients receiving taxanes were more likely to develop significant pain (50.8% versus 23%, p < 0.001). There were no significant differences in baseline pain scores or change in pain scores between study groups. There were no significant differences between groups in analgesic use. Among patients receiving taxane, 90% benefited from loratadine, compared to 27.3% in the placebo arm (p = 0.0008). Both study groups receiving taxanes showed increased worst pains scores from baseline.
In the total sample, antihistamine prophylaxis did not demonstrate a benefit for prevention of CSF-induced bone pain. Findings suggest that there may be some effects for patients receiving taxanes; however, the sample size is too small to draw firm conclusions.
This study did not show any benefit of antihistamine for prevention of CSF-related bone pain. Findings suggest that further research in this area is needed, and specific examination of any benefits in patients receiving taxanes should be further investigated.