Cancer-associated PainNCT02151513
Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
An observational study of Cancer-associated Pain, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to examine the changes in immune function, as measured by biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid medications for the treatment of moderate to severe cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-associated Pain
- What is being tested?
- Intrathecal Pump Placement
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to 1 Jun 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer-associated pain who are receiving an intrathecal pump for management of cancer pain
Who may be able to join
- Diagnosis of cancer
- Evaluation by a pain management physician and confirmation that cancer is the primary etiology of patient's pain
- Moderate to severe pain, as specified by a baseline Pain Rating Score of 5 or above on a scale from 0 (no pain) to 10 (worst pain imaginable) despite current opioid therapy
- Pain management plan (as developed by Interventional Pain Service, patient and primary service) that includes placement of an intrathecal drug delivery system for pain management
- Able and willing to give informed consent
Who cannot join
- Patients with an expected life expectancy of less than 12 weeks
- Patients not felt be a safe surgical candidate by pain management physician for placement of and intrathecal drug delivery system (IDDS) due to the presence of severe medical comorbidities
- Patients who are not a candidate for intrathecal drug therapy due to coagulopathy, concurrent necessary use of blood thinners, presence of systemic infection, drug allergy to analgesic agent, evidence of CSF obstruction or other technical factor
- Severe or untreated psychiatric disease
- Refusal of informed consent
- Pregnant patients or patients less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Hosptial
Salt Lake City, Utah, 84112
About this study
The purpose of this study is to examine the changes in immune function, as measured by biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid medications for the treatment of moderate to severe cancer pain.
Hypothesis: Treatment of pain with intrathecal (spinal) therapy is associated with little alteration of immune function as measured by biomarkers in the blood of cancer patients with moderate to severe pain.
Read the detailed description
Biomarkers of immune function will be measured before and after patients receive an intrathecal pain pump for management of cancer pain.
- Conditions
- Cancer-associated Pain
- Being tested
- Intrathecal Pump Placement
- Keywords
- Cancer-associated pain, Immune function
- 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 Pump PlacementDevice
Also called Medtronic SyncroMed II
| Study group | Role | What they receive |
|---|---|---|
| Cancer Pain | Placement of an intrathecal pump Receives: Device: Intrathecal Pump Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarker values
Change in biomarker values as measured by blood
Measured: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Secondary outcomes (3)
Change in Quality of Life as measured by a Brief Pain Inventory
Quality of life surveys as measured by a Brief Pain Inventory questionnaire
Measured: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Change in Quality of Life as measured by MD Anderson Symptom Inventory
Quality of life surveys as measured by MD Anderson Symptom Inventory questionnaire
Measured: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Serum Opioid Levels
Serum Opioid Levels
Measured: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start1 Apr 2014
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-associated PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shane Brogan, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151513
- Sponsor's protocol ID
- IRB_00057738
- Status last verified
- Jun 2023
- First submitted
- 28 May 2014
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
- ClinicalTrials.gov ID
- NCT02151513
- Acronym / sponsor ID
- IRB_00057738
- Conditions
- Cancer-associated Pain
- Keywords
- Cancer-associated pain, Immune function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 30 May 2014 (estimated)
- 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.
The purpose of this study is to examine the changes in immune function, as measured by biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid medications for the treatment of moderate to severe cancer pain.
Hypothesis: Treatment of pain with intrathecal (spinal) therapy is associated with little alteration of immune function as measured by biomarkers in the blood of cancer patients with moderate to severe pain.
Detailed description
Biomarkers of immune function will be measured before and after patients receive an intrathecal pain pump for management of cancer pain.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Pain | – | Device: Intrathecal Pump PlacementPlacement of an intrathecal pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer-associated pain who are receiving an intrathecal pump for management of cancer pain
Key inclusion criteria (5 listed)
- Diagnosis of cancer
- Evaluation by a pain management physician and confirmation that cancer is the primary etiology of patient's pain
- Moderate to severe pain, as specified by a baseline Pain Rating Score of 5 or above on a scale from 0 (no pain) to 10 (worst pain imaginable) despite current opioid therapy
- Pain management plan (as developed by Interventional Pain Service, patient and primary service) that includes placement of an intrathecal drug delivery system for pain management
- Able and willing to give informed consent
Key exclusion criteria (6 listed)
- Patients with an expected life expectancy of less than 12 weeks
- Patients not felt be a safe surgical candidate by pain management physician for placement of and intrathecal drug delivery system (IDDS) due to the presence of severe medical comorbidities
- Patients who are not a candidate for intrathecal drug therapy due to coagulopathy, concurrent necessary use of blood thinners, presence of systemic infection, drug allergy to analgesic agent, evidence of CSF obstruction or other technical factor
- Severe or untreated psychiatric disease
- Refusal of informed consent
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 Pump PlacementAlso: Medtronic SyncroMed II | Device | Cancer Pain |
Primary outcome
Change in biomarker values
Time frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Change in biomarker values as measured by blood
3 secondary outcomes
Change in Quality of Life as measured by a Brief Pain Inventory
Time frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Change in Quality of Life as measured by MD Anderson Symptom Inventory
Time frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Serum Opioid Levels
Time frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
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 9 Jun 2023.
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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?
An observational study of Cancer-associated Pain, run by University of Utah at 1 site in United States.
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 5 inclusion and 6 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 9 Jun 2023. 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 United States. 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 biomarker values (time frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement). 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 Jun 2023.