Clinical trial NCT01716065: Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Anesthesia, Circulating tumor cells
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Circulating Tumor Cells
timeFrame: 5 days
Secondary outcomes:
measure: Levels of cytokines
timeFrame: 5 days
measure: breast cancer antibodies
timeFrame: 5 days
measure: Dendritic Cells
timeFrame: 5 days
measure: T and B lymphocytes
timeFrame: 5 days
measure: Natural Killer Cells (NK cells)
timeFrame: 5 days
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References: