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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589494
• Other study ID #: 493
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 16, 2020
• Est. completion date: May 2021

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: shereen M Kamal, Associate professor
• Phone: 01006279209
• Email: sheridouh79[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Chronic Pain

Intervention

Drug:
• Tramadol Hydrochloride
tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in PD1 and PD1ligand	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.	baseline(0), day15 , day 30
Secondary	pain assessment	patient describ his pain severty from 0= no pain to 10= the most sever pain	baseline(0), day15 ,day 30