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

June 7, 2023 updated by: Shane Brogan, University of Utah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer Pain
Placement of an intrathecal pump
Device: Intrathecal Pump Placement
Other Names:
  • Medtronic SyncroMed II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in biomarker values
Time Frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
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
Time Frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
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
Time Frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimated)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00057738

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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