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Anesthetic Effect on Immune Cell in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT02758249
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Seong-Hyop Kim, Konkuk University Medical Center

Brief Summary:

Anesthetics agents has an effect on immune response during the cancer surgery.This influence can regulatory to immune activity or cancer cell survival.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Sevoflurane Drug: propofol Not Applicable

Detailed Description:

The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

  1. immediate before anesthesia induction
  2. postoperative 1 hours
  3. postoperative 24 hours

Immune cells isolation from patients peripheral blood mononuclear cells. Next, immune cell were co-culture with human cancer cell line (MCF-7) for 24 hours. investigation for immune cell or cancer cell survival by flow cytometry.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Anesthetic Effect on Immune Cell in Patients With Cancer
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: sevoflurane
patients under sevoflurane anesthesia
Drug: Sevoflurane
patients are anesthetized by using sevoflurane inhalation

Active Comparator: propofol
patients under propofol anesthesia
Drug: propofol
patients are anesthetized by using propofol infusion




Primary Outcome Measures :
  1. immune cell (NK cell and CD8+ T cell) [ Time Frame: up to 24 hours ]
    Patients blood sample are collect up to 24 hours postoperatively. These blood sample are collect in EDTA tube for NK cell and CD8+ T cell isolation from peripheral blood mononuclear cells (PBMCs). Isolation for NK cell, Ab stain with CD16 and CD56. Also, isolation for CD8+ T cell, Ab stain with CD8, that are purified from PBMCs, using FACSAria according to the manufacturer's protocol. These cell are culture with MCF-7 cancer cell line for 24 hours. After 24h, the degree of apoptosis of NK cell and CD8+ T cell was determined by flow cytometry. Suspension cell is NK cell or CD8+ T cell, these cells were harvest and washed with cell staining buffer. After washing, cell resuspended with Annexin-V binding buffer and stained with FITC-Annexin-V according to the manufacturer's protocol with analysis


Secondary Outcome Measures :
  1. cancer cell (MCF-7) apoptosis [ Time Frame: Baseline. postoperative 1 hours and 24 hours ]
    Patients blood sample are collect before and 1h after anesthesia induction and at 24h postoperatively. These blood sample are collect in EDTA tube for NK cell and CD8+ T cell isolation from peripheral blood mononuclear cells (PBMCs). Isolation for NK cell, Ab stain with CD16 and CD56. Also, isolation for CD8+ T cell, Ab stain with CD8, that are purified from PBMCs, using FACSAria according to the manufacturer's protocol. These cell are culture with MCF-7 cancer cell line for 24 hours. After 24h, the degree of apoptosis of cancer cell was determined by flow cytometry. Adherent cell is cancer cell, these cells were harvest and washed with cell staining buffer. After washing, cell resuspended with Annexin-V binding buffer and stained with FITC-Annexin-V according to the manufacturer's protocol with analysis



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient who was planned to undergo breast cancer surgery.

Exclusion Criteria:

  • age < 20 years old
  • history of hypersensitivity reaction in propofol or sevoflurane
  • history of previous cancer
  • patient with ongoing inflammation

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): NCT02758249


Locations
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Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
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Principal Investigator: Seong-Hyop Kim, M.D., Ph.D. Konkuk University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seong-Hyop Kim, Associate Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02758249    
Other Study ID Numbers: KUH1160098
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation