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Spinal pain pump may offer relief for cancer patients when opioids fail

NCT ID NCT07691840

Symptom relief Sponsor: Universitair Ziekenhuis Brussel Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests whether a small pump implanted in the abdomen that delivers pain medicine directly to the spinal fluid can improve quality of life for people with severe cancer pain that is not controlled by oral opioids. Participants are randomly assigned to get the pump or to continue with standard oral pain medications. The study measures quality of life, comfort, and survival over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intrathecal drug delivery system (implanted pump delivering morphine and/or local anesthetics into spinal fluid)
What this could lead to
If it works, this could offer a more effective way to manage severe cancer pain with fewer side effects than high-dose oral opioids.
What could go wrong
This is a moderate-sized trial, and the pump implant is a surgical procedure with risks like infection or device malfunction. It may not improve quality of life more than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer Cancer Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Conventional medical management Intrathecal drug delivery Refractory cancer pain

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • UZ Brussel

    RECRUITING

    Jette, 1090, Belgium

    Contact Email: •••••@•••••

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