Treatment of Cancer Pain Using an Implantable Intrathecal Pump

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.

Study Overview

• Status: Completed
• Conditions: Cancer Pain; Neoplasm-Related Pain
• Intervention / Treatment: Device: Implantable Intrathecal Pump; Device: Subcutaneous Analgesic Pump

Detailed Description

This prospective interventional clinical study investigates the use of an implantable intrathecal pump for the management of refractory cancer-related pain. Patients with advanced malignant disease and insufficient pain control despite optimized systemic opioid therapy are included.

Participants are assigned to one of two treatment approaches: implantation of an intrathecal pump for continuous intrathecal delivery of analgesic medication, or standard care using a subcutaneous infusion pump delivering equipotent analgesic doses. Analgesic regimens are adjusted according to clinical response and patient needs.

Pain intensity is assessed using validated pain scales, and symptom burden is monitored regularly. Quality of life is evaluated using standardized questionnaires at baseline and during follow-up. Additional outcomes include opioid consumption, adverse events, and patient satisfaction with pain management.

The study is conducted at a single tertiary oncology center and follows ethical principles outlined in the Declaration of Helsinki. All participants provide written informed consent prior to enrollment. Findings from this study are intended to inform clinical decision-making and support the integration of implantable intrathecal pumps into standard oncological pain management.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrathecal Pump Group; Implantable intrathecal pump used for continuous intrathecal delivery of analgesic medication for cancer pain.	Device: Implantable Intrathecal Pump; Implantable intrathecal pump surgically implanted for continuous delivery of analgesic medication into the intrathecal space for management of refractory cancer-related pain.
Active Comparator: Subcutaneous Pump Group; Subcutaneous infusion pump used for continuous analgesic medication delivery.	Device: Subcutaneous Analgesic Pump; Subcutaneous infusion pump used for continuous delivery of analgesic medication in patients with cancer-related pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intrathecal pump; Cancer pain management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cancer Pain
• Other Study ID Numbers: OIL-ITP-2022; ERID-KSOPKR-0062/2022 (Other Identifier: Clinical Research Unit, Institute of Oncology Ljubljana)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No