The Change of NK Cell Activity After Head and Neck Cancer Surgery

The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661776
• Other study ID #: 4-2015-0987
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: September 27, 2017
• Start date: March 24, 2016
• Est. completion date: May 4, 2017

Study information

• Verified date: September 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. In addition, the use of opioids as analgesics during the perioperative period depress cellular immunity, in particular the activity of the natural killer (NK) cells. This perioperative immunosuppression may cause deleterious consequences on postoperative outcome in cancer patients. The aim of this study is to confirm the presence or extent of the change of NK cell activity between before and after head and neck surgery. Additionally, investigators will identify the clinical or genetic factors related to the change of NK cell activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1) The patients undergoing head and neck surgery including tumor removal and reconstruction with flap

Exclusion Criteria:

1. patients refusal

2. patients not able to read, or understand the consent form

3. History of Active viral or bacterial infection

4. History of use of immunosuppressive drugs within the last six months

5. History of chemotherapy

6. History of autoimmune disorders

7. Known HIV, Hepatitis B, or Hepatitis C infection

8. Female who is pregnant, nursing

9. ethnicity, other than asian

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of NK cell activity	Preoperative NK cell activity will be measured using the NK vue diagnostic test before surgery and anesthesia. Postoperative NK cell activity will be measured using the NK vue diagnostic test after 24 hours since stopping the use of intravenous remifentanil as analgesics during anesthesia in the operating room or sedation in the intensive care unit.	24 hours