Chronic Pain
Conditions
Keywords
morphine, tramadol, PD1 and PD1 ligand
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
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.
Interventions
DRUGTramadol Hydrochloride
tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
tramadol or morphine
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| pain assessment | baseline(0), day15 ,day 30 | patient describ his pain severty from 0= no pain to 10= the most sever pain |
Countries
Egypt
Contacts
Primary Contactshereen M Kamal, Associate professor
Backup ContactHassan M Kotb, Professor
Outcome results
None listed