Anesthesia and Circulating Tumor Cells in Breast Cancer

April 10, 2020 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden
    • ZH
      • Zurich, ZH, Switzerland, CH-8091
        • University Hospital Zurich, Institute of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane
General anesthesia using Sevoflurane
Drug: Sevoflurane
Active Comparator: Propofol
General anesthesia using propofol TCI
Drug: Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of CTC before and after administration of anesthetics
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Beatrice Beck Schimmer, Prof MD, University Hospital Zurich, Institute of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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