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Anesthesia and Circulating Tumor Cells in Breast Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005770
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Female Breast Carcinoma Drug: Sevoflurane Drug: Propofol Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.
Actual Study Start Date : March 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sevoflurane
General anesthesia using Sevoflurane
 Drug: Sevoflurane
Active Comparator: Propofol
General anesthesia using propofol TCI
 Drug: Propofol


Outcome Measures
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Primary Outcome Measures :
  1. Number of CTC before and after administration of anesthetics [ Time Frame: 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005770


Locations
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Switzerland
University Hospital Zurich, Institute of Anesthesiology
Zurich, ZH, Switzerland, CH-8091
Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Institute of Anesthesiology
  Study Documents (Full-Text)

Documents provided by University of Zurich:
Study Protocol  [PDF] March 20, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02005770    
Other Study ID Numbers: 2013-0408
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Neoplasm Metastasis
Carcinoma
Neoplastic Cells, Circulating
Skin Diseases
Neoplastic Processes
 Pathologic Processes
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation