Cancer PainNCT07427888
Treatment of Cancer Pain Using an Implantable Intrathecal Pump
A study testing Subcutaneous Analgesic Pump and Implantable Intrathecal Pump in people with Cancer Pain and Neoplasm-Related Pain, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cancer Pain, Neoplasm-Related Pain
- What is being tested?
- Subcutaneous Analgesic Pump and Implantable Intrathecal Pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This prospective interventional clinical study investigates the use of an implantable intrathecal pump for the management of refractory cancer-related pain. Patients with advanced malignant disease and insufficient pain control despite optimized systemic opioid therapy are included.
Participants are assigned to one of two treatment approaches: implantation of an intrathecal pump for continuous intrathecal delivery of analgesic medication, or standard care using a subcutaneous infusion pump delivering equipotent analgesic doses. Analgesic regimens are adjusted according to clinical response and patient needs.
Pain intensity is assessed using validated pain scales, and symptom burden is monitored regularly. Quality of life is evaluated using standardized questionnaires at baseline and during follow-up. Additional outcomes include opioid consumption, adverse events, and patient satisfaction with pain management.
The study is conducted at a single tertiary oncology center and follows ethical principles outlined in the Declaration of Helsinki. All participants provide written informed consent prior to enrollment. Findings from this study are intended to inform clinical decision-making and support the integration of implantable intrathecal pumps into standard oncological pain management.
- Conditions
- Cancer Pain, Neoplasm-Related Pain
- Being tested
- Subcutaneous Analgesic Pump, Implantable Intrathecal Pump
- Keywords
- Intrathecal pump, Cancer pain management
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous Analgesic PumpDevice
Subcutaneous infusion pump used for continuous delivery of analgesic medication in patients with cancer-related pain.
Implantable Intrathecal PumpDevice
Implantable intrathecal pump surgically implanted for continuous delivery of analgesic medication into the intrathecal space for management of refractory cancer-related pain.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Pump Group | Experimental | Implantable intrathecal pump used for continuous intrathecal delivery of analgesic medication for cancer pain. Receives: Device: Implantable Intrathecal Pump |
| Subcutaneous Pump Group | Active comparator | Subcutaneous infusion pump used for continuous analgesic medication delivery. Receives: Device: Subcutaneous Analgesic Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Change in pain intensity assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain), including assessment of average and maximum pain.
Measured: Baseline and 4 weeks after initiation of analgesic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Oct 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, non-randomized, parallel-group interventional study comparing intrathecal pump analgesia with subcutaneous analgesic infusion in patients with cancer-related pain.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427888
- Sponsor's protocol ID
- OIL-ITP-2022
- Other IDs
- ERID-KSOPKR-0062/2022
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cancer Pain Using an Implantable Intrathecal Pump
- ClinicalTrials.gov ID
- NCT07427888
- Acronym / sponsor ID
- OIL-ITP-2022
- Conditions
- Cancer Pain, Neoplasm-Related Pain
- Keywords
- Intrathecal pump, Cancer pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Feb 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.
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.
Detailed description
This prospective interventional clinical study investigates the use of an implantable intrathecal pump for the management of refractory cancer-related pain. Patients with advanced malignant disease and insufficient pain control despite optimized systemic opioid therapy are included.
Participants are assigned to one of two treatment approaches: implantation of an intrathecal pump for continuous intrathecal delivery of analgesic medication, or standard care using a subcutaneous infusion pump delivering equipotent analgesic doses. Analgesic regimens are adjusted according to clinical response and patient needs.
Pain intensity is assessed using validated pain scales, and symptom burden is monitored regularly. Quality of life is evaluated using standardized questionnaires at baseline and during follow-up. Additional outcomes include opioid consumption, adverse events, and patient satisfaction with pain management.
The study is conducted at a single tertiary oncology center and follows ethical principles outlined in the Declaration of Helsinki. All participants provide written informed consent prior to enrollment. Findings from this study are intended to inform clinical decision-making and support the integration of implantable intrathecal pumps into standard oncological pain management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, non-randomized, parallel-group interventional study comparing intrathecal pump analgesia with subcutaneous analgesic infusion in patients with cancer-related pain.
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Pump Group | Experimental | Device: Implantable Intrathecal PumpImplantable intrathecal pump used for continuous intrathecal delivery of analgesic medication for cancer pain. |
| Subcutaneous Pump Group | Active comparator | Device: Subcutaneous Analgesic PumpSubcutaneous infusion pump used for continuous analgesic medication delivery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Subcutaneous Analgesic PumpSubcutaneous infusion pump used for continuous delivery of analgesic medication in patients with cancer-related pain. | Device | Subcutaneous Pump Group |
| Implantable Intrathecal PumpImplantable intrathecal pump surgically implanted for continuous delivery of analgesic medication into the intrathecal space for management of refractory cancer-related pain. | Device | Intrathecal Pump Group |
Primary outcome
Change in Pain Intensity
Time frame: Baseline and 4 weeks after initiation of analgesic therapy
Change in pain intensity assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain), including assessment of average and maximum pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Analgesic Pump and Implantable Intrathecal Pump in people with Cancer Pain and Neoplasm-Related Pain, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 23 Feb 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline and 4 weeks after initiation of analgesic therapy). 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 23 Feb 2026.