Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
Study Details
Study Description
Brief Summary
this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: tramadol group tramadol hydrochloride 100 mg three times daily |
Drug: Tramadol Hydrochloride
tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily
Other Names:
|
Active Comparator: morphine group morphine 30 mg twise times daily |
Drug: Tramadol Hydrochloride
tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- changes in PD1 and PD1ligand [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.
Secondary Outcome Measures
- pain assessment [baseline(0), day15 ,day 30]
patient describ his pain severty from 0= no pain to 10= the most sever pain
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Assiut University | Assiut | Egypt | 171516 |
Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: Shereen M Kamal, Associate Professor, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 493