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

Phase 2

• Conditions: Chronic Pain
• Interventions: Drug: Tramadol Hydrochloride

• Registration Number: NCT04589494
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14
• Primary Completion: 2021-02
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
morphine group	Tramadol Hydrochloride	morphine 30 mg twise times daily
tramadol group	Tramadol Hydrochloride	tramadol hydrochloride 100 mg three times daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
pain assessment	baseline(0), day15 ,day 30	patient describ his pain severty from 0= no pain to 10= the most sever pain

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt