Back to resultsAssessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propofol group
sevoflurane group
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
propofol group
sevoflurane group
Arm Description
The patient who anesthetized by using propofol.
The patient who anesthetized by using propofol
Outcomes
Primary Outcome Measures
CD39 and CD73 on circulating regualtory T cells
change of percentage of CD39 and CD73 (scores range from 0 to 100)
Secondary Outcome Measures
Circulating natural killer cells
change of percentage of circulating natural killer cell (scores range from 0 to 100)
Full Information
NCT ID
NCT02567929
First Posted
September 2, 2015
Last Updated
March 30, 2018
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02567929
Brief Title
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
Official Title
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
immediate before anesthesia induction
postoperative 1 hours
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propofol group
Arm Type
Active Comparator
Arm Description
The patient who anesthetized by using propofol.
Arm Title
sevoflurane group
Arm Type
Active Comparator
Arm Description
The patient who anesthetized by using propofol
Intervention Type
Drug
Intervention Name(s)
propofol group
Other Intervention Name(s)
propofol
Intervention Description
Patient will be anesthetized by using propofol infusion during operation.
Intervention Type
Drug
Intervention Name(s)
sevoflurane group
Other Intervention Name(s)
sevoflurane
Intervention Description
Patient will be anesthetized by using sevoflurane inhalation during operation.
Primary Outcome Measure Information:
Title
CD39 and CD73 on circulating regualtory T cells
Description
change of percentage of CD39 and CD73 (scores range from 0 to 100)
Time Frame
preoperative time. postoperative 1 hours and 24 hours
Secondary Outcome Measure Information:
Title
Circulating natural killer cells
Description
change of percentage of circulating natural killer cell (scores range from 0 to 100)
Time Frame
preoperative time. postoperative 1 hours and 24 hours
Other Pre-specified Outcome Measures:
Title
Circulating type 1 and type 17 helper T cells
Description
change of percentage of helper T cell (scores range from 0 to 100)
Time Frame
preoperative time. postoperative 1 hours and 24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hyop Kim, M.D,Ph.D
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
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