Kanker gerelateerde pijn Cancer pain Cancer-related pain
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 years; - Able to understand the written information and able to give informed consent. - Current treatment with subcutaneous fentanyl and planned to rotate to transdermal fentanyl - To ensure steady-state kinetics, patients must have been treated with subcutaneous fentanyl for at least 40 hours prior to the rotation and have been treated with a stable fentanyl dose at least 20 hours prior to the rotation This way, fentanyl pharmacokinetics are at steady-state.
Exclusion criteria
Exclusion criteria: - Patients that use short-acting fentanyl via the oral, (oral mucosal, sublingual), intranasal or subcutaneous administration route 12 hours prior to the rotation will be excluded as this influences the pharmacokinetic profile of the subcutaneous administration. This implicates that patients will be prescribed oral short acting oxycodone or morphine 12 hours before rotation as these are mostly used next to treatment with transdermal fentanyl. - Patients that use strong CYP3A4 inhibitors or inducers, as spacified by the KNMP kennisbank, will be excluded as the model did not account for the influence of strong CYP3A4 inhibition or induction on fentanyl pharmacokinetics while the effects have been shown in multiple studies. - Patients that are rotated using a dose conversion ratio other than 1:1 will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prove bioequivalence in fentanyl exposure (measured as area under the curve (AUC)) pre- and post-rotation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To associate the occurrence and severity of adverse events and pain scores pre- and post-rotation with pharmacokinetic parameters. | — |
Countries
Netherlands
Outcome results
None listed