CompletedNot Applicable

Treatment of Cancer Pain Using an Implantable Intrathecal Pump

Slovenia8 participantsStarted 2022-10-01

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Pain Intensity

Timeframe: Baseline and 4 weeks after initiation of analgesic therapy

Trial details

NCT IDNCT07427888

SponsorInstitute of Oncology Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31