To hear about similar clinical trials, please enter your email below
Trial Title:
Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
NCT ID:
NCT06498037
Condition:
Cancer Pain
Conditions: Official terms:
Cancer Pain
Fentanyl
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
a single-arm PK-study design
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fentanyl
Description:
Administration of subcutaneously administered fentanyl loading boluses
Arm group label:
Intervention arm
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Bram C Agema
Phone:
+31107040704
Email:
b.agema@erasmusmc.nl
Start date:
February 23, 2024
Completion date:
December 2, 2025
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498037
