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

Phase 4

Recruiting

• Conditions: Cancer Pain
• Interventions: Drug: Fentanyl

• Registration Number: NCT06498037
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-23
• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	48 hours after dose increase	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%.

Secondary Outcome Measures

Name	Time	Method
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.	up to 48 hours after dose increase	This will be performed as a descriptive analysis
Describe the course of patient reported pain intensity in the 48 hours following the loading boluses.	up to 48 hours after dose increase	This will be performed as a descriptive analysis
Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus.	up to 48 hours after dose increase	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

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands