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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567929
• Other study ID #: KUH1160086
• Status: Completed
• Phase: N/A
• First received: September 2, 2015
• Last updated: March 30, 2018
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• propofol group
Patient will be anesthetized by using propofol infusion during operation.
• sevoflurane group
Patient will be anesthetized by using sevoflurane inhalation during operation.

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Circulating type 1 and type 17 helper T cells	change of percentage of helper T cell (scores range from 0 to 100)	preoperative time. postoperative 1 hours and 24 hours
Primary	CD39 and CD73 on circulating regualtory T cells	change of percentage of CD39 and CD73 (scores range from 0 to 100)	preoperative time. postoperative 1 hours and 24 hours
Secondary	Circulating natural killer cells	change of percentage of circulating natural killer cell (scores range from 0 to 100)	preoperative time. postoperative 1 hours and 24 hours