Clinical trial NCT02151513: Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
Official title: Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer-associated Pain
Keywords: Cancer-associated pain
Immune function
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer-associated pain who are receiving an intrathecal pump for management of cancer pain

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in biomarker values
timeFrame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Secondary outcomes:
measure: Change in Quality of Life as measured by a Brief Pain Inventory
timeFrame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
measure: Change in Quality of Life as measured by MD Anderson Symptom Inventory
timeFrame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
measure: Serum Opioid Levels
timeFrame: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hosptial
state: Utah
Study officials:
References: