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临床试验/NCT04589494
NCT04589494Unknown2 期

Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain

Assiut University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年4月16日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

tramadol hydrochloride 100 mg three times daily

干预措施: Tramadol Hydrochloride (Drug)

morphine group

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shereen Mamdouh

Lectruer of anesthesia, ICU and pain manegement

Assiut University

研究点 (1)

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