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

This study is not yet open for participant recruitment.
Verified November 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02005770
First received: December 3, 2013
Last updated: December 6, 2013
Last verified: November 2013
  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
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, Division of Anaesthesiology Not yet recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Division of Anaesthesiology
  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: December 6, 2013
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on April 16, 2014