Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)

Breast Cancer Clinical Trial

— CTC  

Official title:

Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716065
• Other study ID #: 355841-17
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: April 29, 2014
• Start date: June 2012

Study information

• Verified date: April 2014
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to determine whether the type of anesthesia during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. If the investigators find that one type of anesthesia versus the other is more beneficial to a patient's immune system, then the investigators may use this information to design a larger study to exam the effect of anesthesia better.

Description:

There are two different types of anesthesia that the investigators can use for subjects undergoing breast surgery. The first type is called "general anesthesia" (GA) which is when a person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain medicine during and after surgery to minimize surgical pain. The other type of anesthesia is called "regional anesthesia" (RA), or "nerve blocks" which numb up the nerves that supply the breast area. By doing this type of anesthesia, subjects often don't go "to sleep" with a breathing tube, instead, they get heavy IV sedation and take a "deep nap" during the surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male and female subjects should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy

• Written informed consent must be obtained from each subject prior to entering the study

• Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary lymph node dissection

• Able to stay overnight in the hospital post surgery

Exclusion Criteria:

• Any subject younger than 18 years or older than 85 years of age

• History of previous breast surgery (aside from biopsy), planned breast conserving operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap)

• American Society of Anesthesia (ASA) classification of 4 or greater, or any contraindication to having regional anesthesia

• Any subjects who receives an intraoperative or postoperative blood transfusion during the period of venous blood sampling

• Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing (urine HCG) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study

• Subjects with active infectious process at the site of proposed paravertebral injection

• Subjects with significant allergy to local anesthetics

• Subjects who convert from RA to GA during surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating Tumor Cells	blood will be drawn preoperative( at least 24 hours before surgery), immediate prior to surgery, immediately postoperative, 12-24 hours postoperative, and at postoperative appointment	5 days	No
Secondary	Levels of cytokines		5 days	No
Secondary	breast cancer antibodies		5 days	No
Secondary	Dendritic Cells		5 days	No
Secondary	T and B lymphocytes		5 days	No
Secondary	Natural Killer Cells (NK cells)		5 days	No