To prospectively validate the pharmacokinetics of fentanyl during the current standard-of-care rotation scheme from subcutaneous to transdermal fentanyl administration in patients with moderate to severe cancer-related pain. We aim to prove bio-…
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Brief title
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- Other condition
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Health condition
Kanker gerelateerde pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To prove bioequivalence in fentanyl exposure (measured as area under the curve
(AUC)) pre- and post-rotation.
Secondary outcome
To associate the occurrence and severity of adverse events and pain scores pre-
and post-rotation with pharmacokinetic parameters.
Background summary
Fentanyl is a strong-acting, widely used opioid in the treatment of
cancer-related pain. In hospitalized patients with severe pain, fast dose
titration of fentanyl can be performed by combined continuous and bolus
subcutaneous administration. When stable pain control is reached, a rotation to
transdermal patches can be done. The fentanyl rotation-scheme used in Erasmus
MC was previously based on data concerning rotation from intravenous fentanyl.
Based on a PK modeling study with subcutaneous fentanyl (METC nr.09-332) and
clinical observations, the fentanyl rotation scheme has been optimized and the
rotation scheme is now used in standard clinical practice. However, this scheme
has never been validated prospectively on PK and PD-endpoints.
Study objective
To prospectively validate the pharmacokinetics of fentanyl during the current
standard-of-care rotation scheme from subcutaneous to transdermal fentanyl
administration in patients with moderate to severe cancer-related pain. We aim
to prove bio-equivalence before and after fentanyl rotation using the area
under the curve (AUC).
Study design
Real-life observational study in patients who are rotated from a subcutaneous
to a transdermal administration route for fentanyl according to the current
standard of care in the Erasmus Medical Centre. Due to the use of the
previously developed model the number of blood samples will be very sparse. We
plan to collect 2-3 randomly taken samples prior to the rotation and 2-3 random
samples after the rotation. The acquired exposure quantified as AUC will be
compared pre- and post-rotation with a paired t-test. Patients complete the
study when all blood samples are taken or when the patient is discharged from
the hospital.
Study burden and risks
The risk of the extra blood withdrawals is negligible.
dr. Molewaterplein 40
Rotterdam 3000 CA
NL
dr. Molewaterplein 40
Rotterdam 3000 CA
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78595.078.21 |