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

Completed

• Conditions: Cancer-associated Pain
• Interventions: Device: Intrathecal Pump Placement

• Registration Number: NCT02151513
• Lead Sponsor: University of Utah

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04-01
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Pain	Intrathecal Pump Placement	Placement of an intrathecal pump

Primary Outcome Measures

Name	Time	Method
Change in biomarker values	Before, 4 weeks after and 8 weeks after intrathecal pump placement	Change in biomarker values as measured by blood

Secondary Outcome Measures

Name	Time	Method
Serum Opioid Levels	Before, 4 weeks after and 8 weeks after intrathecal pump placement	Serum Opioid Levels
Change in Quality of Life as measured by a Brief Pain Inventory	Before, 4 weeks after and 8 weeks after intrathecal pump placement	Quality of life surveys as measured by a Brief Pain Inventory questionnaire
Change in Quality of Life as measured by MD Anderson Symptom Inventory	Before, 4 weeks after and 8 weeks after intrathecal pump placement	Quality of life surveys as measured by MD Anderson Symptom Inventory questionnaire

Trial Locations

Locations (1)

Huntsman Cancer Hosptial; 🇺🇸 Salt Lake City, Utah, United States