Optimizing fentanyl dosing for cancer pain management
Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
This study is testing if giving extra doses of fentanyl faster can help people with cancer pain feel better without waiting as long for the medication to work.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06498037 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of loading boluses in increasing the dose of subcutaneous fentanyl for patients suffering from cancer-related pain. The primary goal is to determine if plasma concentrations of fentanyl after 12 hours of dose augmentation are non-inferior to those measured after 48 hours. Patients will receive additional loading doses, and plasma pharmacokinetic samples will be collected to assess the outcomes. This approach aims to enhance pain management by achieving adequate fentanyl exposure more rapidly.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are currently receiving or planning to receive subcutaneous fentanyl for cancer-related pain.
Not a fit: Patients who are pregnant, breastfeeding, or using alternative forms of fentanyl delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for cancer patients, allowing for quicker relief from pain.
How similar studies have performed: There is limited information on similar studies, making this approach relatively novel in the context of optimizing fentanyl dosing for cancer pain.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rotterdam, South Holland
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Bram C Agema
- Email: b.agema@erasmusmc.nl
- Phone: +31107040704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.