Actively Recruiting
Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
Led by Erasmus Medical Center · Updated on 2024-07-12
45
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 6518 years
- Able to understand the written information and able to give informed consent
- Current or planned treatment with subcutaneous fentanyl for cancer-related pain
You will not qualify if you...
- Pregnancy or breastfeeding
- Use of fentanyl in forms other than subcutaneous (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
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Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
B
Bram C Agema
CONTACT
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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