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

January 13, 2021 updated by: Shereen Mamdouh, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hassan M Kotb, Professor
  • Phone Number: 01287332042
  • Email: kotbhi@yahoo.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline(0), day15 , day 30

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2020

Primary Completion (ANTICIPATED)

February 1, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 493

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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