Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain

Study Overview
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Brief Summary
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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
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Biomarkers of immune function will be measured before and after patients receive an intrathecal pain pump for management of cancer pain.

Official Title
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Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain

Conditions
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Cancer-associated Pain

Intervention / Treatment
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* Device: Intrathecal Pump Placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Pain<br>Placement of an intrathecal pump | Device: Intrathecal Pump Placement<br> <br> * Other names: Medtronic SyncroMed II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarker values | Change in biomarker values as measured by blood | Before, 4 weeks after and 8 weeks after intrathecal pump placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life as measured by a Brief Pain Inventory | Quality of life surveys as measured by a Brief Pain Inventory questionnaire | 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 | Before, 4 weeks after and 8 weeks after intrathecal pump placement | 
| Serum Opioid Levels | Serum Opioid Levels | Before, 4 weeks after and 8 weeks after intrathecal pump placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer-associated pain, Immune function