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

Overview

this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain

Full Title of Study: “Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: February 2021

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

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

Arms, Groups and Cohorts

  • Active Comparator: tramadol group
    • tramadol hydrochloride 100 mg three times daily
  • Active Comparator: morphine group
    • morphine 30 mg twise times daily

Clinical Trial Outcome Measures

Primary Measures

  • changes in PD1 and PD1ligand
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shereen Mamdouh, Lectruer of anesthesia, ICU and pain manegement – Assiut University
  • Overall Official(s)
    • Shereen M Kamal, Associate Professor, Principal Investigator, Assiut University
  • Overall Contact(s)
    • shereen M Kamal, Associate professor, 01006279209, sheridouh79@yahoo.com

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