Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
Suresh Kumar
Primary Investigator
Brief description of study.
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer Pain
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Age: 18 years - 120 years
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Gender: All
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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