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

NCT06498037 | Recruiting Phase 4

• 1 other identifier: 2023-507355-30
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• 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%.

  48 hours after dose increase

Secondary Outcomes (3)

• 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

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

  up to 48 hours after dose increase

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

  up to 48 hours after dose increase

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Drug: Fentanyl

Interventions

Fentanyl DRUG

Administration of subcutaneously administered fentanyl loading boluses

Intervention arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bram C Agema

CONTACT

+31107040704; b.agema@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.R.H.J. Mathijssen

Model Details: a single-arm PK-study design

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 12, 2024
• Study Start: February 23, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 2, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)