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

Erasmus University

Status and phase: Enrolling; Phase 4

Conditions: Cancer Pain

Treatments: Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06498037

2023-507355-30

Details and patient eligibility

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Intervention arm

Experimental group

Description:

Patients are given loading doses when dose-increasing fentanyl. The concentrations at 12 and 48 hours after dose increase will be compared

Treatment:

Drug: Fentanyl