Intrathecal drug delivery vs standard care for severe cancer pain
Official title: Intrathecal Drug Delivery Systems Versus Comprehensive Medical Management for Severe Cancer Pain: a Randomized Controlled Trial
Run by Universitair Ziekenhuis Brussel · NCT07691840 · Data updated 2026-11-12
This trial tests whether delivering pain medicine directly into the spinal fluid helps people with severe cancer pain experience better relief than usual oral medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Jette) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | October 31, 2029 |
| Study ends | October 31, 2029 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07691840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced cancer and refractory pain who are on or require continued opioid therapy and are suitable for intrathecal therapy.
✕Probably not a fit
Patients whose pain is not primarily driven by mechanisms amenable to intrathecal delivery or who experience prohibitive complications may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares intrathecal drug delivery with conventional medical management for adults with severe, refractory cancer pain. Participants must have ongoing opioid use and failed or intolerant systemic opioid therapy. The study aims to see if targeted intrathecal infusion improves health-related quality of life compared with standard oral pain medications. Enrollment is at a single center, with follow-up likely to monitor pain, side effects, and overall well-being.
Why it matters
Potential benefit: If successful, patients could experience better pain control with fewer systemic side effects, potentially improving quality of life.
How similar studies have gone: Previous work in intrathecal therapy for cancer-related pain has shown potential benefits in pain relief and reduced systemic medication needs, though results vary by patient and setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) with severe cancer refractory pain (all types of cancer), who have been receiving treatment with oral/systemic opioids for at least 4 weeks, and are expected to remain on opioids for the entire duration of the study. More than one opioid rotation has to be done before defining pain refractoriness. * Intrathecal therapy is recommended because of inefficacy or intolerance to strong systemic opioid treatment. Inefficacy is defined as mean daily visual analogue scale (VAS) pain intensity score at rest of ≥ 50 mm. Intolerance is defined as the occurrence of (S)AEs (even with dosage less than 200 mg/day of oral morphine equivalents) which prevents a further increase in the opioid dosage to obtain pain relief. * Patients suitable for IDD and with the ability to comply with the medical protocol and visits. * Survival prognosis of ≥ 6 months. Exclusion Criteria: * Patients with active, severe infection. * Patients with known brain metastases. * Patients with high risk of hemorrhaging. * Patients with respiratory depression (for use of morphine). * Patients with severe respiratory compromise; baseline oxygen SpO2 \< 90%, chronic CO2 retention. * Patients with severe cardiac disease or risk of cardiotoxicity (for use of bupivacaine). * Patients with severe liver impairment or liver failure (for use of ropivacaine). * Patients with allergies for medication or IDD hardware. * Pregnant or lactating women. * Women who plan to become pregnant within 1 month after the study.
Where it's running
-
UZ Brussel
Jette, Belgium Recruiting
Study contacts
- Study coordinator: Maarten Moens, MD PhD MBA
- Email: stimulusresearchgroup@gmail.com
- Phone: +3224775514
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.