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

NCT04589494 | Unknown Phase 2

• 1 other identifier: 493
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain

Keywords

morphine; tramadol; PD1 and PD1 ligand

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline(0), day15 , day 30

Secondary Outcomes (1)

• pain assessment

  baseline(0), day15 ,day 30

Study Arms (2)

tramadol group

ACTIVE COMPARATOR

tramadol hydrochloride 100 mg three times daily

Drug: Tramadol Hydrochloride

morphine group

ACTIVE COMPARATOR

morphine 30 mg twise times daily

Drug: Tramadol Hydrochloride

Interventions

Tramadol Hydrochloride DRUG

tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily

Also known as: morphine sulphate

morphine group; tramadol group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Tramadol; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Shereen M Kamal, Associate Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shereen M Kamal, Associate professor

CONTACT

01006279209; sheridouh79@yahoo.com

Hassan M Kotb, Professor

CONTACT

01287332042; kotbhi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: tramadol or morphine
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lectruer of anesthesia, ICU and pain manegement

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 19, 2020
• Study Start: April 16, 2020
• Primary Completion: February 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

EG (1)