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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-23

Study Completion Date

2025-12-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a single-arm PK-study design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention arm

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Administration of subcutaneously administered fentanyl loading boluses

Interventions

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Fentanyl

Administration of subcutaneously administered fentanyl loading boluses

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No