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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2021-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

tramadol or morphine

Study Groups

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tramadol group

tramadol hydrochloride 100 mg three times daily

Group Type ACTIVE_COMPARATOR

Tramadol Hydrochloride

Intervention Type DRUG

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

morphine group

morphine 30 mg twise times daily

Group Type ACTIVE_COMPARATOR

Tramadol Hydrochloride

Intervention Type DRUG

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

Interventions

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Tramadol Hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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morphine sulphate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No