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

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tramadol Hydrochloride
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring morphine, tramadol, PD1 and PD1 ligand

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

tramadol group

morphine group

Arm Description

tramadol hydrochloride 100 mg three times daily

morphine 30 mg twise times daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

pain assessment
patient describ his pain severty from 0= no pain to 10= the most sever pain

Full Information

First Posted
September 14, 2020
Last Updated
January 13, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04589494
Brief Title
Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
Official Title
Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
morphine, tramadol, PD1 and PD1 ligand

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
tramadol or morphine
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tramadol group
Arm Type
Active Comparator
Arm Description
tramadol hydrochloride 100 mg three times daily
Arm Title
morphine group
Arm Type
Active Comparator
Arm Description
morphine 30 mg twise times daily
Intervention Type
Drug
Intervention Name(s)
Tramadol Hydrochloride
Other Intervention Name(s)
morphine sulphate
Intervention Description
tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily
Primary Outcome Measure Information:
Title
changes in PD1 and PD1ligand
Description
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.
Time Frame
baseline(0), day15 , day 30
Secondary Outcome Measure Information:
Title
pain assessment
Description
patient describ his pain severty from 0= no pain to 10= the most sever pain
Time Frame
baseline(0), day15 ,day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shereen M Kamal, Associate professor
Phone
01006279209
Email
sheridouh79@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan M Kotb, Professor
Phone
01287332042
Email
kotbhi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Associate Professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
171516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahar A. Mohamed, MD
Phone
01003611410
Email
drsaher2008@yahoo.com
First Name & Middle Initial & Last Name & Degree
Shereen M. Mohamed, MD
Phone
01006279209
Email
sheridouh79@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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