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
  Purpose

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

Condition Intervention Phase
Female Breast Carcinoma
Drug: Sevoflurane
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Proportion of "CTC positive" patients before and after administration of anesthetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sevoflurane
General anesthesia using Sevoflurane
Drug: Sevoflurane
Active Comparator: Propofol
General anesthesia using propofol TCI
Drug: Propofol

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005770

Contacts
Contact: Beatrice Beck Schimmer, Prof MD beatrice.beck@usz.ch

Locations
Switzerland
University Hospital Zurich, Institute of Anesthesiology Recruiting
Zurich, ZH, Switzerland, CH-8091
Contact: Beatrice Beck-Schimmer, Prof MD       beatrice.beck@usz.ch   
Sub-Investigator: Frédérique Hovaguimian, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Institute of Anesthesiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02005770     History of Changes
Other Study ID Numbers: 2013-0408
Study First Received: December 3, 2013
Last Updated: April 25, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on September 22, 2014