NCT07427888

Brief Summary

This study evaluates the effectiveness and safety of an implantable intrathecal pump for the treatment of cancer-related pain compared with standard subcutaneous analgesic infusion. Cancer-related pain can be difficult to control with systemic opioid therapy and is often associated with significant side effects and reduced quality of life. Implantable intrathecal pumps allow direct delivery of analgesic medication into the intrathecal space, enabling effective pain control with lower drug doses and fewer systemic adverse effects. The study compares pain intensity, symptom burden, medication requirements, and quality of life in patients receiving analgesia via an implantable intrathecal pump versus those treated with a subcutaneous pump. The results of this study aim to support the introduction of implantable intrathecal pumps into routine clinical practice for selected patients with refractory cancer pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 4, 2026

Last Update Submit

February 16, 2026

Conditions

Cancer PainNeoplasm-Related Pain

Keywords

Intrathecal pumpCancer pain management

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity

    Change in pain intensity assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain), including assessment of average and maximum pain.

    Baseline and 4 weeks after initiation of analgesic therapy

Study Arms (2)

Intrathecal Pump Group

EXPERIMENTAL

Implantable intrathecal pump used for continuous intrathecal delivery of analgesic medication for cancer pain.

Device: Implantable Intrathecal Pump

Subcutaneous Pump Group

ACTIVE COMPARATOR

Subcutaneous infusion pump used for continuous analgesic medication delivery.

Device: Subcutaneous Analgesic Pump

Interventions

Subcutaneous Analgesic PumpDEVICE

Subcutaneous infusion pump used for continuous delivery of analgesic medication in patients with cancer-related pain.

Subcutaneous Pump Group
Implantable Intrathecal PumpDEVICE

Implantable intrathecal pump surgically implanted for continuous delivery of analgesic medication into the intrathecal space for management of refractory cancer-related pain.

Intrathecal Pump Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced malignant disease.
  • Age between 40 and 80 years.
  • Cancer-related pain with intensity ≥ 5 on the Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) despite optimized conventional analgesic therapy.
  • Daily opioid requirement equivalent to ≥ 200 mg oral morphine, or inability to tolerate systemic opioid therapy due to adverse effects.
  • Expected life expectancy of at least 6 months.
  • Physical condition allowing implantation of an intrathecal pump or use of a subcutaneous infusion pump.
  • Ability to understand the study procedures and provide written informed consent

You may not qualify if:

  • Refusal or inability to provide informed consent.
  • Severe cardiac disease (NYHA class \> III).
  • Severe chronic obstructive pulmonary disease (FEV1 \< 40%).
  • Presence of significant neurological disease.
  • Presence of severe psychiatric disorder.
  • Regular use of psychotropic medications that could interfere with pain assessment.
  • Age younger than 40 years or older than 80 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, non-randomized, parallel-group interventional study comparing intrathecal pump analgesia with subcutaneous analgesic infusion in patients with cancer-related pain.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 23, 2026

Study Start

October 1, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)