Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- changes in PD1 and PD1ligand
研究概览
简要总结
this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain
详细描述
The use of opioids is the mainstay in the treatment of many types of chronic pain, including cancer and non-cancer-related pain]. Opioids are known to suppress immune function following both acute and chronic administration; however, they appear to be different according to the schedule of administration as well as the state of the organism. Programmed death-1 (PD-1, also known as CD279) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
tramadol or morphine
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cancer pain of varying etiology,
- •documented metastatic cancer, currently on step I WHO ladder and whose pain necessitates a shift to step II,
- •those who have never received radiotherapy, chemotherapy, or immunosuppressive drugs, -- and in good general and nutritional condition and without infectious diseases at the time of investigation.
排除标准
- •abnormal hepatic, renal, and pulmonary function, gastrointestinal pathology, and
- •those with cerebral metastases and/or psychological disorders,
- •patients with contraindication to morphine or tramadol according to their respective data sheets, and
- •patients who could not complete the diary information correctly.
研究组 & 干预措施
tramadol group
tramadol hydrochloride 100 mg three times daily
干预措施: Tramadol Hydrochloride (Drug)
morphine group
morphine 30 mg twise times daily
干预措施: Tramadol Hydrochloride (Drug)
结局指标
主要结局
changes in PD1 and PD1ligand
时间窗: baseline(0), day15 , day 30
this is flow cytomertic analyses to the human peripheral blood mononuclear cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately.
次要结局
- pain assessment(baseline(0), day15 ,day 30)
研究者
Shereen Mamdouh
Lectruer of anesthesia, ICU and pain manegement
Assiut University
