Cancer Pain
Conditions
Brief summary
The primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with SC fentanyl in patients with cancer. The primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient. Patients will be treated with additional loading boluses and plasma-PK samples will be obtained.
Interventions
DRUGFentanyl
Administration of subcutaneously administered fentanyl loading boluses
Sponsors
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
a single-arm PK-study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; * Able to understand the written information and able to give informed consent. * Current or planned treatment with SC fentanyl for cancer-related pain
Exclusion criteria
* Pregnancy or/ and breastfeeding * Other ways of using fentanyl (sublingual, nasal spray and oromucosal) * Liver function CPS B or C * The use of strong CYP3A4 inhibitors of inducers \[9\] * Presence of somnolence, respiratory depression or CTCAE grade 2 adverse events.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach | 48 hours after dose increase | Using a paired t-test the geometric mean of the ratio of the two fentanyl plasma concentrations will be compared. The 90% confidence interval of the geomteric mean should fall within the range of 80 - 125%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigate the safety of the loading bolus strategy by assessing whether CTCAE grade III or higher occur as a consequence of the fentanyl loading boluses. | up to 48 hours after dose increase | This will be performed as a descriptive analysis |
| Describe the course of patient reported pain intensity in the 48 hours following the loading boluses. | up to 48 hours after dose increase | This will be performed as a descriptive analysis |
| Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus. | up to 48 hours after dose increase | The pharmacokinetic data will be imputed into a population pharmacokinetic model that allows to simulate other situations and dosing regimens which will be used to further optimize dosing of subcutaneously administered fentanyl |
Countries
Netherlands
Contacts
Primary ContactBram C Agema
Outcome results
None listed