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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01716065
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : April 30, 2014
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management

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.

Condition or disease
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
Actual Enrollment : 12 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Circulating Tumor Cells [ Time Frame: 5 days ]
    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

Secondary Outcome Measures :
  1. Levels of cytokines [ Time Frame: 5 days ]
  2. breast cancer antibodies [ Time Frame: 5 days ]
  3. Dendritic Cells [ Time Frame: 5 days ]
  4. T and B lymphocytes [ Time Frame: 5 days ]
  5. Natural Killer Cells (NK cells) [ Time Frame: 5 days ]

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01716065

United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management

Responsible Party: Defense and Veterans Center for Integrative Pain Management Identifier: NCT01716065     History of Changes
Other Study ID Numbers: 355841-17
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014

Keywords provided by Defense and Veterans Center for Integrative Pain Management:
Anesthesia, Circulating tumor cells

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Central Nervous System Depressants
Physiological Effects of Drugs