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

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT02151513
Collaborator
(none)
51
Enrollment
1
Location
50
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intrathecal Pump Placement

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
51 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Cancer Pain

Placement of an intrathecal pump

Device: Intrathecal Pump Placement
Other Names:
  • Medtronic SyncroMed II

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. Serum Opioid Levels [Before, 4 weeks after and 8 weeks after intrathecal pump placement]

      Serum Opioid Levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huntsman Cancer Hosptial Salt Lake City Utah United States 84112

    Sponsors and Collaborators

    • University of Utah

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shane Brogan, Associate Professor, Anesthesiology, University of Utah
    ClinicalTrials.gov Identifier:
    NCT02151513
    Other Study ID Numbers:
    • IRB_00057738
    First Posted:
    May 30, 2014
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by Shane Brogan, Associate Professor, Anesthesiology, University of Utah
    Cancer-associated pain
    Immune function
    Additional relevant MeSH terms:
    Cancer Pain

    Study Results

    No Results Posted as of Jul 5, 2019