Intrathecal Drug DeliveryCAREGIVERNCT07691840
Intrathecal Therapy Versus Standard Care for Severe Cancer Pain
A study testing Intrathecal Drug Delivery and Comprehensive Medical Management in people with Intrathecal Drug Delivery and Refractory Cancer Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrathecal Drug Delivery, Refractory Cancer Pain, Conventional Medical Management
- What is being tested?
- Intrathecal Drug Delivery and Comprehensive Medical Management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, 1090
Maarten Moens, MD PhD MBA, +3224775514, stimulusresearchgroup@gmail.com
Ulrike Van Hoey, MSc
About this study
Official title: Intrathecal Drug Delivery Systems Versus Comprehensive Medical Management for Severe Cancer Pain: a Randomized Controlled Trial
Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Conventional pharmacologic management, ranging from simple analgesics to strong opioids, is frequently limited by insufficient efficacy and systemic side effects. Intrathecal drug delivery (IDD) offers targeted, continuous medication infusion directly into the intrathecal space, allowing lower systemic doses and potentially reducing side effects while maintaining effective analgesia. The CAREGIVER study is a randomized, controlled trial designed to evaluate whether patients with severe refractory cancer pain receiving IDD experience a difference in HRQoL compared to those receiving conventional medical management (CMM) with oral pain medications.
- Being tested
- Intrathecal Drug Delivery, Comprehensive Medical Management
- Keywords
- Intrathecal pumps, Intrathecal drug delivery, Refractory cancer pain, Health-related quality of life, Neuromodulation
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Drug DeliveryProcedure or surgery
Patients assigned to the IDD-group (intervention group) will undergo implantation of an IDD pump (Synchromed™, Medtronic). The device will be placed subcutaneously in the abdominal region and connected to a catheter delivering pain medication directly into the intrathecal space surrounding the spinal cord. At the time of implantation, the pump will be filled with medication, such as morphine, local anesthetics, or a combination thereof, and an initial daily dose will be selected.
In the days following surgery, dose titration will be performed to establish the optimal balance between pain relief and tolerability. Following implantation, the most common postoperative procedure is the drug refill. This involves aseptic access to the pump reservoir, removal of any residual volume, and replenishment with a fresh dose of medication. Refill intervals will depend on the patient's daily dosage, ranging from monthly to once every 2-3 months.
Comprehensive Medical ManagementDrug
Participants randomized to the CMM-group will receive standard care.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Drug Delivery | Active comparator | Not described Receives: Procedure: Intrathecal Drug Delivery |
| Comprehensive Medical Management | Active comparator | Not described Receives: Drug: Comprehensive Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Health-related quality of life will be evaluated with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Measured: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
Secondary outcomes (11)
Patient comfort
Patient comfort is evaluated with the General Comfort Questionnaire (GCQ), a self-reported instrument consisting of 48 items that reflect the physical, spiritual, environmental, and social dimension.
Measured: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Survival
The survival rate will be determined by recording the time from treatment initiation until death.
Measured: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Pain intensity
Pain intensity will be measured with the Visual Analogue Scale (ranging from 0 (no pain) to 100 (maximal pain)) in electronic format. Momentary data collection will be used to collect pain intensity scores for VAS (valid and reliable for pain experience), whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias.
Measured: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
Perceived stress
Perceived stress will be assessed by using the 10-item Perceived Stress Scale.
Measured: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Anxiety
Patient anxiety will be provided through the State Trait Anxiety Inventory (STAI).
Measured: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Perceived Injustice
Using the Injustice Experience Questionnaire (IEQ), perceived injustice related to current health status will be assessed.
Measured: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Self-efficacy
The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy.
Measured: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Caregiver burden
To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed. This 12-item self-report instrument assesses caregiver burden and is a shortened version of the original 22-item Zarit Burden Scale.
Measured: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Health expenditure
Expenditures related to in-hospital care will be extracted from hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients, conducted each month after treatment initiation. During these calls, researchers will ask patients whether they have had any medical consultations, hospital admissions, AEs, changes in medication (such as daily morphine, MED, antidepressants,…), or incurred any additional healthcare costs.
Measured: monthly after treatment initiation until 12 months
Safety
Recording of (serious) adverse events.
Measured: Throughout the duration of the study, an average of 12 months.
Number of responders
Responder status will be determined based on pain scores, adverse events, and medication dose changes. Responders are defined as patients achieving a clinically meaningful reduction in pain intensity (≥30% from baseline) without intolerable adverse effects.
Measured: at 1, 2, 4, 6, and 12 months post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal Drug DeliveryStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691840
- Sponsor's protocol ID
- 2025-522381-68-00
- Other IDs
- 2025
- Acronym
- CAREGIVER
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Drug Delivery Systems Versus Comprehensive Medical Management for Severe Cancer Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07691840
- Acronym / sponsor ID
- CAREGIVER / 2025-522381-68-00
- Keywords
- Intrathecal pumps, Intrathecal drug delivery, Refractory cancer pain, Health-related quality of life, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Conventional pharmacologic management, ranging from simple analgesics to strong opioids, is frequently limited by insufficient efficacy and systemic side effects. Intrathecal drug delivery (IDD) offers targeted, continuous medication infusion directly into the intrathecal space, allowing lower systemic doses and potentially reducing side effects while maintaining effective analgesia. The CAREGIVER study is a randomized, controlled trial designed to evaluate whether patients with severe refractory cancer pain receiving IDD experience a difference in HRQoL compared to those receiving conventional medical management (CMM) with oral pain medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Drug Delivery | Active comparator | Procedure: Intrathecal Drug Delivery |
| Comprehensive Medical Management | Active comparator | Drug: Comprehensive Medical Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal Drug DeliveryPatients assigned to the IDD-group (intervention group) will undergo implantation of an IDD pump (Synchromed™, Medtronic). The device will be placed subcutaneously in the abdominal region and connected to a catheter delivering pain medication directly into the intrathecal space surrounding the spinal cord. At the time of implantation, the pump will be filled with medication, such as morphine, local anesthetics, or a combination thereof, and an initial daily dose will be selected. In the days following surgery, dose titration will be performed to establish the optimal balance between pain relief and tolerability. Following implantation, the most common postoperative procedure is the drug refill. This involves aseptic access to the pump reservoir, removal of any residual volume, and replenishment with a fresh dose of medication. Refill intervals will depend on the patient's daily dosage, ranging from monthly to once every 2-3 months. | Procedure or surgery | Intrathecal Drug Delivery |
| Comprehensive Medical ManagementParticipants randomized to the CMM-group will receive standard care. | Drug | Comprehensive Medical Management |
Primary outcome
Health-related quality of life
Time frame: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
Health-related quality of life will be evaluated with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
11 secondary outcomes
Patient comfort
Time frame: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Survival
Time frame: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Pain intensity
Time frame: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation
Perceived stress
Time frame: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Anxiety
Time frame: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Perceived Injustice
Time frame: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Self-efficacy
Time frame: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Caregiver burden
Time frame: At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation
Health expenditure
Time frame: monthly after treatment initiation until 12 months
Safety
Time frame: Throughout the duration of the study, an average of 12 months.
Number of responders
Time frame: at 1, 2, 4, 6, and 12 months post-treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Drug Delivery and Comprehensive Medical Management in people with Intrathecal Drug Delivery and Refractory Cancer Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, MD PhD MBA (+3224775514, stimulusresearchgroup@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.