Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
NCT ID: NCT02151513
Last Updated: 2023-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2014-04-01
2018-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cancer Pain
Placement of an intrathecal pump
Intrathecal Pump Placement
Interventions
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Intrathecal Pump Placement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Shane Brogan
Associate Professor, Anesthesiology
Locations
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Huntsman Cancer Hosptial
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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IRB_00057738
Identifier Type: -
Identifier Source: org_study_id
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