NCT02151513

Completed

Pilot Study on the Effect of Intrathecal Opioids on Immune F...

University of Utah Source

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Other study identifiers

Sponsor study identifier

IRB_00057738

Study Type

observational

Actual enrollment (reported)

51

Locations

1 country

Sites

1

Timeline

Study Start

April 1, 2014

Actual (reported)

Primary Completion

June 1, 2018

Actual (reported)

Study Completion

June 1, 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 51 participants
Study completion date: June 1, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 1, 2014
Actual (reported)
First Submitted
May 28, 2014
Actual (reported)
First Posted
May 30, 2014
Actual (reported)
Primary Completion
June 1, 2018
Actual (reported)
Study Completion
June 1, 2018
Actual (reported)

Last Updated: June 9, 2023
Status Verified: June 2023
Last Update Submitted: June 7, 2023

Conditions

Cancer-associated Pain

Keywords

Cancer-associated painImmune function

Outcome Measures

Primary Outcomes (1)

Change in biomarker values
Change in biomarker values as measured by blood
Before, 4 weeks after and 8 weeks after intrathecal pump placement

Secondary Outcomes (3)

Change in Quality of Life as measured by a Brief Pain Inventory
Before, 4 weeks after and 8 weeks after intrathecal pump placement
Change in Quality of Life as measured by MD Anderson Symptom Inventory
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

Study Arms (1)

Cancer Pain

Placement of an intrathecal pump

Device: Intrathecal Pump Placement

Interventions

Intrathecal Pump PlacementDevice

Also known as: Medtronic SyncroMed II

Cancer Pain

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Diagnosis of cancer

Sponsors & Collaborators

University of Utah
Otherlead

Study Sites (1)

Huntsman Cancer Hosptial

Salt Lake City, Utah, 84112, United States

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

51 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor, Anesthesiology

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

April 1, 2014

Actual (reported)

NCT04095234

Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)

Phase 2Active Not Recruiting

NCT00804076

Gene Transfer for Cancer Pain

Phase 1Completed

NCT05910190

Buprenorphine for Cancer Pain

Phase 4Unknown

NCT05917171

Pilot Trial of an Online Pain Coping Skills Training Program in Spanish

Not ApplicableCompleted

NCT07605546

RAD ONC FREEDOM Oncology Pain

Not ApplicableRecruiting

NCT01384877

Subcutaneous Lidocaine For Cancer-Related Pain

Phase 2/3Completed

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

June 1, 2018

Actual (reported)

Study Completion

June 1, 2018

Actual (reported)

Last Updated

June 9, 2023

Record last verified: 2023-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02151513
Data provider: ClinicalTrials.gov
Source updated: 2023-06-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:33 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Cancer Pain

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations