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Anesthesia and Circulating Tumor Cells in Breast Cancer

This study is currently recruiting participants.
Verified June 2016 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT02005770
First Posted: December 9, 2013
Last Update Posted: June 20, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
December 3, 2013
December 9, 2013
June 20, 2016
March 2014
August 2017   (Final data collection date for primary outcome measure)
Number of CTC before and after administration of anesthetics [ Time Frame: 5 days ]
Proportion of "CTC positive" patients before and after administration of anesthetics [ Time Frame: 5 days ]
Complete list of historical versions of study NCT02005770 on ClinicalTrials.gov Archive Site
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Anesthesia and Circulating Tumor Cells in Breast Cancer
Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.
Serious concern about the role of anesthesia in tumor recurrence has considerably risen over years, but the lack of surrogate markers for tumor spreading made trials addressing this issue difficult to realize. In breast cancer patients CTC positivity has been recently recognized as an independent prognostic factor. In this respect, we postulated that in a first step changes in the number of CTC after general anesthesia would help to determine the effect of anesthesia on this tumor marker.
Patients with primary breast cancer will be randomized to either propofol or sevoflurane anesthesia for curative surgery. CTC will be determined in the pre- as well as postoperative phase and the kinetic of CTC in the two groups will be compared.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Female Breast Carcinoma
  • Drug: Sevoflurane
  • Drug: Propofol
  • Experimental: Sevoflurane
    General anesthesia using Sevoflurane
    Intervention: Drug: Sevoflurane
  • Active Comparator: Propofol
    General anesthesia using propofol TCI
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
231
August 2017
August 2017   (Final data collection date for primary outcome measure)

Inclusion criteria: > Female

  • Age 18 to 85
  • ASA I-III
  • Primary breast cancer (TNM stage = T1-3, N0-2, M0)
  • Primary surgery
  • Written informed consent

Exclusion criteria:

  • Metastatic breast cancer
  • Other than primary surgery (recurrence, reconstruction)
  • Pre-operative chemotherapy or radiotherapy
  • Auto-immune disease, HIV, other active cancer, age>85, ASA IV or V
  • Concomitant regional anesthesia
  • Chronic opioids medication
  • Any systemic immunosuppressive therapy
  • Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
  • Known hypersensitivity to volatile anesthetics (malignant hyperthermia)
  • Pregnancy
  • Breast feeding
  • Non German-speaking patients
  • Enrollment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion
Sexes Eligible for Study: Female
18 Years to 85 Years   (Adult, Senior)
No
Contact: Beatrice Beck Schimmer, Prof MD beatrice.beck@usz.ch
Contact: Martin Schläpfer, MD martin.schlaepfer@usz.ch
Switzerland
 
 
NCT02005770
2013-0408
Yes
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University of Zurich
University of Zurich
Not Provided
Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Institute of Anesthesiology
University of Zurich
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP