Clinical trial · Observational
Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
NCT02151513CI-TRIAL-00067055completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-associated Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrathecal Pump Placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer Pain
- description
- Placement of an intrathecal pump
- interventionNames
- Device: Intrathecal Pump Placement
Primary outcomes (1)
- measure
- Change in biomarker values
- timeFrame
- Before, 4 weeks after and 8 weeks after intrathecal pump placement
- description
- Change in biomarker values as measured by blood
Secondary outcomes (3)
- measure
- Change in Quality of Life as measured by a Brief Pain Inventory
- timeFrame
- Before, 4 weeks after and 8 weeks after intrathecal pump placement
- description
- Quality of life surveys as measured by a Brief Pain Inventory questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.