Actively Recruiting
Optimizing Subcutaneous Fentanyl Titration for Rapid Adequate Exposure in Cancer-Related Pain
Led by Erasmus Medical Center · Updated on 2024-07-12
45
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of administering additional loading boluses when increasing the dose of subcutaneous fentanyl in patients experiencing cancer-related pain. The main goal is to demonstrate that fentanyl plasma levels 12 hours after dose increase are not inferior to levels 48 hours after dose increase within the same patient. This Phase 4 study focuses on optimizing fentanyl dosing to better manage cancer pain. Participants will receive subcutaneous fentanyl loading boluses as their dose is increased. The study compares fentanyl concentrations at two time points: 12 hours and 48 hours after the dose augmentation. This approach aims to assess how quickly adequate fentanyl exposure is achieved following dose adjustments. During the study, participants will have plasma samples taken to measure fentanyl levels. Researchers will monitor safety by checking for severe adverse events within 48 hours after dose increase. Patient-reported pain intensity will be tracked over this same period. The study will also evaluate how rapidly fentanyl is absorbed after subcutaneous bolus administration. The total duration of participation and follow-up is centered around the 48-hour period post-dose increase.
CONDITIONS
Brief Title
Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to understand written information and provide informed consent
- Currently receiving or planning treatment with subcutaneous fentanyl for cancer-related pain
You will not qualify if you...
- Pregnancy or breastfeeding
- Use of fentanyl by other methods such as sublingual, nasal spray, or oromucosal
- Liver function classified as CPS B or C
- Use of strong CYP3A4 inhibitors or inducers
- Presence of somnolence, respiratory depression, or CTCAE grade 2 adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours after dose increase
Participants receive subcutaneously administered fentanyl loading boluses to manage cancer-related pain and achieve adequate drug exposure rapidly.
Visits occur during the 48 hours following dose increases to monitor fentanyl plasma concentrations and patient-reported pain intensity
Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
B
Bram C Agema
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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