Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Circulating Tumor Cells [ Time Frame: 5 days ] [ Designated as safety issue: No ]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
- Levels of cytokines [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- breast cancer antibodies [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Dendritic Cells [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- T and B lymphocytes [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Natural Killer Cells (NK cells) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Samples collected for CTC analysis (2 tubes of 8ml of blood) will be drawn at 4 time points: pre-operative (at least 24 hours before surgery), immediate prior to surgery, 12-24 hours post-operative, and 5-7 days post-operative.
|Study Start Date:||June 2012|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716065
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|