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

NCT02151513 | Completed

• 1 other identifier: IRB_00057738
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-associated Pain

Keywords

Cancer-associated pain; Immune function

Outcome Measures

Primary Outcomes (1)

• Change in biomarker values

  Change in biomarker values as measured by blood

  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

  Before, 4 weeks after and 8 weeks after intrathecal pump placement

• Change in Quality of Life as measured by MD Anderson Symptom Inventory

  Before, 4 weeks after and 8 weeks after intrathecal pump placement

• Serum Opioid Levels

  Before, 4 weeks after and 8 weeks after intrathecal pump placement

Study Arms (1)

Cancer Pain

Placement of an intrathecal pump

Device: Intrathecal Pump Placement

Interventions

Intrathecal Pump Placement DEVICE

Also known as: Medtronic SyncroMed II

Cancer Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer-associated pain who are receiving an intrathecal pump for management of cancer pain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Hosptial

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Anesthesiology

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

US (1)