Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    Erasmus Medical Center
Updated on 20 November 2025

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.

Details
Condition Cancer Pain
Age 18years - 120years
Clinical Study IdentifierNCT06498037
SponsorErasmus Medical Center
Last Modified on20 November 2025

Eligibility

Yes No Not Sure

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
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