Anesthesia and Circulating Tumor Cells in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Zurich
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: December 3, 2013
Last updated: December 15, 2014
Last verified: December 2014

December 3, 2013
December 15, 2014
January 2014
December 2015   (final data collection date for primary outcome measure)
Number of CTC before and after administration of anesthetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Proportion of "CTC positive" patients before and after administration of anesthetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02005770 on 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.
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Identifier (NCT Number) in Medline.
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion criteria: > Female

  • Age 18 to 85
  • 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
18 Years to 85 Years
Contact: Beatrice Beck Schimmer, Prof MD
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Institute of Anesthesiology
University of Zurich
December 2014

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