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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04589494
Collaborator
(none)
15
1
2
12.5
1.2

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
  • Drug: Tramadol Hydrochloride
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

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
tramadol or morphine
Primary Purpose:
Treatment
Official Title:
Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
Actual Study Start Date :
Apr 16, 2020
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
May 1, 2021

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:
  • morphine sulphate
  • 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:
  • morphine sulphate
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    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.
    Responsible Party:
    Shereen Mamdouh, Lectruer of anesthesia, ICU and pain manegement, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04589494
    Other Study ID Numbers:
    • 493
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Jan 14, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shereen Mamdouh, Lectruer of anesthesia, ICU and pain manegement, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 14, 2021