Anesthetic Effect on Immune Cell in Patients With Cancer

January 23, 2018 updated by: Seong-Hyop Kim, Konkuk University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline. postoperative 1 hours and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Investigators

  • Principal Investigator: Seong-Hyop Kim, M.D., Ph.D., Konkuk University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1160098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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