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

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We will enroll female and male military health care beneficiaries between the ages 18-85 years old presenting with the diagnosis of primary non-metastatic breast cancer, American Joint Committee on Cancer (AJCC) Stages I, II or III, undergoing surgery with curative intent

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Levels of cytokines	5 days
breast cancer antibodies	5 days
Dendritic Cells	5 days
T and B lymphocytes	5 days
Natural Killer Cells (NK cells)	5 days

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (ESTIMATE): October 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2014
• Last Update Submitted That Met QC Criteria: April 29, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Anesthesia, Circulating tumor cells
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasm Metastasis; Breast Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: 355841-17