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Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02005770
First received: December 3, 2013
Last updated: April 25, 2014
Last verified: April 2014

December 3, 2013
April 25, 2014
January 2014
December 2015   (final data collection date for primary outcome measure)
Proportion of "CTC positive" patients before and after administration of anesthetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02005770 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.
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. However, CTC positivity in breast cancer patients has been recently recognized as an independent prognostic factor and proposed as an early indicator for therapy response. In this respect, we postulated that changes in the proportion of CTC-positive patients before and after general anesthesia would help to determine the effect of anesthesia on tumor recurrence.

  • Trial with medicinal product
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
216
December 2015
December 2015   (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
Female
18 Years to 85 Years
No
Contact: Beatrice Beck Schimmer, Prof MD beatrice.beck@usz.ch
Switzerland
 
NCT02005770
2013-0408
Not Provided
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Institute of Anesthesiology
University of Zurich
April 2014

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