Anesthesia and Circulating Tumor Cells in Breast Cancer

Phase 4CompletedNCT02005770

University of Zurich221 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

221

Conditions

Female Breast Carcinoma

Interventions

SevofluraneDRUG

PropofolDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Zurich, Institute of Anesthesiology

Zurich, Canton of Zurich, Switzerland

Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden

Zurich, Switzerland

Outcomes

Primary Outcomes

Number of CTC before and after administration of anesthetics

Time frame: 5 days

Data from ClinicalTrials.gov

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