C-PAIN: Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Pain control.
研究概览
简要总结
This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Persons receiving ongoing oncology care at the University of Chicago Medical Center for whom near-future pain opioid pain medication therapy is anticipated
- •Subjects must be at least 18 years of age.
排除标准
- •Subjects taking an opioid at the time of enrollment, or within the past 30 days
- •Subjects who are currently undergoing palliative radiation
- •Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
- •Subjects with a history of or active blood cancer (e.g., leukemia).
- •Chronic kidney disease, as defined by Glomerular filtration rate (GFR) < 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
- •Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin greater than or equal to1.5 mg/dL, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) greater than or equal to 2.5 X upper limit of normal*. (*Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \ greater than or equal to 5 X upper limit of normal if hepatic metastases are present).
- •Inability to understand and give informed consent to participate in the opinion of the investigator
- •Subjects who are known to be pregnant at the time of enrollment
- •Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.
研究组 & 干预措施
PGx Arm
PGX information is provided to clinicals to inform opioid dosing and selection.
干预措施: Pharmacogenomic (PGx) results. (Other)
Control Arm
No PGX information provided opioid dosing and selection is according to standard of care.
结局指标
主要结局
Pain control.
时间窗: 45 days
Measuring changes in composite pain intensity rating via the numeric rating scale: * Brief Pain Inventory-Short Form (BPI-SF) * Score range: 0 (no pain) to 10 (most pain) * Composite pain intensity score (mean of worst, least, average, and current pain) From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone.
次要结局
- Type of First Opioid Prescribed(From enrollment until study end (up to 5 years))
- Pain Medication Regimen Changes(45 days)
- Hospitalization or Emergency Visit for Pain Control(45 days)
- Cumulative Morphine Equivalents Required(45 days)