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

Phase 4RecruitingNCT06498037

Erasmus Medical Center45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer Pain

Interventions

FentanylDRUG

Administration of subcutaneously administered fentanyl loading boluses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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.

Locations (1)

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach

Using a paired t-test the geometric mean of the ratio of the two fentanyl plasma concentrations will be compared. The 90% confidence interval of the geomteric mean should fall within the range of 80 - 125%.

Time frame: 48 hours after dose increase

Secondary Outcomes

Investigate the safety of the loading bolus strategy by assessing whether CTCAE grade III or higher occur as a consequence of the fentanyl loading boluses.

This will be performed as a descriptive analysis

Time frame: up to 48 hours after dose increase

Describe the course of patient reported pain intensity in the 48 hours following the loading boluses.

This will be performed as a descriptive analysis

Time frame: up to 48 hours after dose increase

Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus.

The pharmacokinetic data will be imputed into a population pharmacokinetic model that allows to simulate other situations and dosing regimens which will be used to further optimize dosing of subcutaneously administered fentanyl

Time frame: up to 48 hours after dose increase

Central Contacts

Bram C Agema

CONTACT

+31107040704 b.agema@erasmusmc.nl

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.