Status:
RECRUITING
Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
Lead Sponsor:
Erasmus Medical Center
Conditions:
Cancer Pain
Eligibility:
All Genders
18-120 years
Phase:
PHASE4
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-infer...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06498037
Start Date
February 23 2024
End Date
December 2 2025
Last Update
July 12 2024
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD