NCT02758249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

February 26, 2016

Last Update Submit

January 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • immune cell (NK cell and CD8+ T cell)

    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 Outcomes (1)

  • cancer cell (MCF-7) apoptosis

    Baseline. postoperative 1 hours and 24 hours

Study Arms (2)

sevoflurane

ACTIVE COMPARATOR

patients under sevoflurane anesthesia

Drug: Sevoflurane

propofol

ACTIVE COMPARATOR

patients under propofol anesthesia

Drug: propofol

Interventions

patients are anesthetized by using sevoflurane inhalation

sevoflurane

patients are anesthetized by using propofol infusion

propofol

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient who was planned to undergo breast cancer surgery.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Related Publications (1)

  • Lim JA, Oh CS, Yoon TG, Lee JY, Lee SH, Yoo YB, Yang JH, Kim SH. The effect of propofol and sevoflurane on cancer cell, natural killer cell, and cytotoxic T lymphocyte function in patients undergoing breast cancer surgery: an in vitro analysis. BMC Cancer. 2018 Feb 7;18(1):159. doi: 10.1186/s12885-018-4064-8.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Seong-Hyop Kim, M.D., Ph.D.

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 26, 2016

First Posted

May 2, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations