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Effect of Anesthesia on Expression of Programmed Death-1 and Programmed Death-1 Ligand in Breast Cancer

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ClinicalTrials.gov Identifier: NCT04657237
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Shereen Mamdouh, Assiut University

Study Description
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Brief Summary:
Surgery is first-line treatment for solid tumors. However, surgical trauma-induced physiologic stress has been demonstrated to facilitate metastasis and recurrence in different types of cancer. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress. Hence, we instigate the effect of anesthetic technique on expression of PD1 and PD1 ligand.

Condition or disease Intervention/treatment Phase
Programmed Cell Death 1 Procedure: Thoracic Paravertebral block Not Applicable

Detailed Description:
The cellular immune response plays a central part in postoperative clearance of tumor cells. T lymphocytes and natural killer (NK) cells are two predominant cytotoxic effector cells that are the major components of antitumor immunity. In mouse models, proliferation of T lymphocytes in response to surgical trauma is defective . Programmed death-1 (PD-1) 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. Hence, we instigate the effect of anesthetic technique on expression of PD1 and PD1 ligand.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Anesthesia and Surgical Stress on the Expression of Programmed Death-1 and Programmed Death-1 Ligand on T Lymphocyte After Breast Cancer Surgeries
Study Start Date : January 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: control group
all patients will receive general anesthesia and will receive intravenous paracetamol (1 g) before skin closure and then given every 6 hrs in the 1st postoperative day
Active Comparator: TPVB group
Patients will receive total volume (20 ml) 0.25% bubivicaine divided equally at each level of T4 and T6 at thoracic paravertebral space then they will recive general anesthesia.
 Procedure: Thoracic Paravertebral block
TPVB will be given using high frequency linear U/S transducer, place the U/S ultrasound probe was placed parallel to the vertebral spine at T4, and, T6 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle was inserted in caudocranial direction using in-plane approach. Confirm negative vessel or pleural breach via aspiration then proceed with local anaesthetic 0.25% bupivacaine (20 ml) delivery slowly divided equally at T4and T6; the pleura will be seen to be pushed downward


Outcome Measures
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Primary Outcome Measures :
  1. change in level of PD1 and PD1 ligand postoperatively [ Time Frame: preoerative (day-0),1st day, and 3 rd day after surgery ]
    blood sample will be withdrawn and human peripheral blood monocyte cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately. For ex vivo experiments, PBMCs will be cultured with Iscove's modified Dulbecco's medium (IMDM) containing 10 % human serum albumin.


Secondary Outcome Measures :
  1. total request of analgesia [ Time Frame: 24 hours postoperative ]
    the total amount of analgesia (paracetamol) will be recorded and calculated


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for breast cancer surgery

Exclusion Criteria:

  • compromised immune function (such as infection with the human immunodeficiency virus, immunodeficiency, or treatment with corticosteroids, immunosuppressive drugs, or chemotherapy)
  • ASA > III
  • age> 70 years old.
  • patients refusal to the procedure.
  • Infection of the skin at or near site of needle puncture.
  • Coagulopathy .
  • Drug hypersensitivity or allergy to the studied drugs.
  • Central or peripheral neuropthy .
  • Pre-operative opoid consumption ( within 24 hours preoperative )
  • Anomalies of the vertebral column .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657237


Contacts
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Contact: shereen M kamal, assocate professor 01006279209 sheridouh79@yahoo.com
Contact: Hassan I Kotb, professor 01287332042 kotbhi@yahoo.com

Locations
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Egypt
South Egypt Cancer Institute Recruiting
Assiut, Egypt, 11715
Contact: Shereen M Kamal, Lecturer    01006279209    sheridouh79@yahoo.com   
Contact: Hassan M Kotb, Professor       kotbhi@yahoo.com   
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Shereen Mamdouh, Lecturer of anesthesia, ICU and pain managment, Assiut University
ClinicalTrials.gov Identifier: NCT04657237    
Other Study ID Numbers: 359
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shereen Mamdouh, Assiut University:
brest cancer
programmed cell death1
programmed cell death ligand 1
Additional relevant MeSH terms:
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Death
Pathologic Processes