Objective: The aim of this study was to evaluate the effect and tolerability of low doses of transdermal (TD) fentanyl patches in opioid-naive patients with cancer pain.
Methods: This was a nonrandomized, open-label, uncontrolled study in fifty consecutive opioid-naive patients with advanced cancer and moderate pain. TD fentanyl was initiated at a dose of 12 µg/h. Doses were then adjusted according to the clinical response. Pain intensity, opioid-related adverse effects, TD fentanyl doses, and quality of life were monitored over 4 weeks. The time to dose stabilization and indexes of dose escalation were also calculated.
Results: Thirty-one patients completed all 4 weeks of the study. Pain control was achieved within a mean of 1.7 days after the start of TS fentanyl therapy. Significant differences in TD fentanyl doses were observed during the study period (P = 0.03). Mean doses were doubled 4 weeks after starting the treatment. The level of adverse effects was acceptable in most patients and only a minority of patients discontinued the treatment (13.8%).
Conclusion: Low doses of TD fentanyl were well tolerated and effective. Observations from this study suggest that randomized, controlled, double-blind studies of TD fentanyl 12 µg/h in opioid-naive patients with cancer pain may be warranted.