Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in biomarker values
研究概览
简要总结
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.
详细描述
Biomarkers of immune function will be measured before and after patients receive an intrathecal pain pump for management of cancer pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in biomarker values
时间窗: Before, 4 weeks after and 8 weeks after intrathecal pump placement
Change in biomarker values as measured by blood
次要结局
- 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)
研究者
Shane Brogan
Associate Professor, Anesthesiology
University of Utah