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

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Chronic Pain

Treatments: Drug: Tramadol Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04589494

493

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

tramadol group

Active Comparator group

Description:

tramadol hydrochloride 100 mg three times daily

Treatment:

Drug: Tramadol Hydrochloride

morphine group

Active Comparator group

Description:

morphine 30 mg twise times daily

Treatment:

Drug: Tramadol Hydrochloride