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

Cancer-associated Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151513
• Other study ID #: IRB_00057738
• Status: Completed
• Start date: April 1, 2014
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Cancer-associated Pain

Intervention

Device:
• Intrathecal Pump Placement

Locations

Country	Name	City	State
United States	Huntsman Cancer Hosptial	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biomarker values	Change in biomarker values as measured by blood	Before, 4 weeks after and 8 weeks after intrathecal pump placement
Secondary	Change in Quality of Life as measured by a Brief Pain Inventory	Quality of life surveys as measured by a Brief Pain Inventory questionnaire	Before, 4 weeks after and 8 weeks after intrathecal pump placement
Secondary	Change in Quality of Life as measured by MD Anderson Symptom Inventory	Quality of life surveys as measured by MD Anderson Symptom Inventory questionnaire	Before, 4 weeks after and 8 weeks after intrathecal pump placement
Secondary	Serum Opioid Levels	Serum Opioid Levels	Before, 4 weeks after and 8 weeks after intrathecal pump placement