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Completed

NCT Number: NCT02151513

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huntsman Cancer Hosptial

Salt Lake City, Utah, 84112, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrathecal Pump Placement

Device

Other names: Medtronic SyncroMed II

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Serum Opioid Levels

    Time frame: Before, 4 weeks after and 8 weeks after intrathecal pump placement

    Serum Opioid Levels

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 30, 2014
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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