To determine and compare PK profiles of two of the most used ROOs in cancer patients: one intranasal fentanyl formulation (INFC, Instanyl®) and one sublingual fentanyl formulation (SLF, Abstral®).
ID
Source
Brief title
Condition
- Other condition
- Metastases
Synonym
Health condition
doorbraakpijn bij kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The determination of pharmacokinetic parameters of two transmucosal fentanyl
products in patients with breakthrough cancer pain in a crossover design.
Secondary outcome
Secundary study parameters are efficacy through pain intensity scores and
patients* preference.
Background summary
For the treatment of breakthrough cancer pain there are six transmucosal
fentanyl products, also called rapid onset opioids (ROOs), available on the
Dutch market (Actiq, Instanyl, Abstral, Effentora, Breakyl, Recivit). These six
products were never directly compared within one study in cancer pain patients.
Physicians currently base their choice of a ROO purely on experience and PK
data, which originate mostly from healthy volunteers and are therefore poor
indicators of PK profiles in cancer patients.
Study objective
To determine and compare PK profiles of two of the most used ROOs in cancer
patients: one intranasal fentanyl formulation (INFC, Instanyl®) and one
sublingual fentanyl formulation (SLF, Abstral®).
Study design
Open label, two period crossover study.
Intervention
Patients will take either INFC or SLF at the start of an BTcP episode. Blood
samples and VAS scores will be taken before and 5, 10, 15, 20, 30, 45, 60, 90,
120 and 240 minutes after ROO administration. Thereafter, patients will receive
the other ROO, either INFC or SLF, during at least three days to titrate to the
optimal dose. After this, the second study period starts. After both periods a
questionnaire about the patients preference will be conducted.
Study burden and risks
This study brings neither added risks nor benefits directly for the patients.
The additional load is 12 blood samples of 2 ml for the determination of PK
data, collected with an indwelling venous catheter (Venflon), a VAS before the
blood sample collection, and a short questionnaire about the patients*
preference.
Reinier de Graafweg 3
Delft 2625AD
NL
Reinier de Graafweg 3
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
* Patients receiving stable maintenance opioid therapy for chronic cancer pain (as specified in SPCs of tested ROOs)
* Patients suffering from BTcP, according to the Davies 2009 criteria. Both incidental and idiopathic BTcP.
* Patients should have an average of 2 (and maximum of 4) episodes of BTcP per day
* Patients must use one of the formulations used in this study for BTcP, either 100 or 200 µg Instanyl® or 200 or 400 µg Abstral®.
* Patients must be mentally competent and therefore able to sign and date a written informed consent prior to entering the study
Exclusion criteria
Sleep apnea, active brain metastases (with increased intracranial pressure), severe COPD, a recent history of substance abuse
Allergy to one of the constituents of the ROOs Instanyl and Abstral
Mucositis
Participation in another clinical trial in the previous 4 weeks
Use of MAO inhibitors
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| EudraCT | EUCTR2015-000983-32-NL |
| CCMO | NL50229.098.15 |