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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier:
NCT01716065
First received: October 17, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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
Breast Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Defense and Veterans Center for Integrative Pain Management:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: June 2012
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716065

Locations
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
  More Information

No publications provided

Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT01716065     History of Changes
Other Study ID Numbers: 355841-17
Study First Received: October 17, 2012
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014