Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer

March 30, 2018 updated by: Seong-Hyop Kim, Konkuk University Medical Center

Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.

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

Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Study Type

Interventional

Enrollment (Actual)

218

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 colon 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol group
The patient who anesthetized by using propofol.
Drug: propofol group
Patient will be anesthetized by using propofol infusion during operation.
Other Names:
  • propofol
Active Comparator: sevoflurane group
The patient who anesthetized by using propofol
Drug: sevoflurane group
Patient will be anesthetized by using sevoflurane inhalation during operation.
Other Names:
  • sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD39 and CD73 on circulating regualtory T cells
Time Frame: preoperative time. postoperative 1 hours and 24 hours
change of percentage of CD39 and CD73 (scores range from 0 to 100)
preoperative time. postoperative 1 hours and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating natural killer cells
Time Frame: preoperative time. postoperative 1 hours and 24 hours
change of percentage of circulating natural killer cell (scores range from 0 to 100)
preoperative time. postoperative 1 hours and 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating type 1 and type 17 helper T cells
Time Frame: preoperative time. postoperative 1 hours and 24 hours
change of percentage of helper T cell (scores range from 0 to 100)
preoperative time. 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

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)

March 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1160086

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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