Clinical trial · Interventional
Treatment of Cancer Pain Using an Implantable Intrathecal Pump
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
| Neoplasm-Related Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implantable Intrathecal Pump | Device | — | UNRESOLVED |
| Subcutaneous Analgesic Pump | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intrathecal Pump Group
- description
- Implantable intrathecal pump used for continuous intrathecal delivery of analgesic medication for cancer pain.
- interventionNames
- Device: Implantable Intrathecal Pump
- type
- ACTIVE_COMPARATOR
- label
- Subcutaneous Pump Group
- description
- Subcutaneous infusion pump used for continuous analgesic medication delivery.
- interventionNames
- Device: Subcutaneous Analgesic Pump
Primary outcomes (1)
- measure
- Change in Pain Intensity
- timeFrame
- Baseline and 4 weeks after initiation of analgesic therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available