Anesthesia and Circulating Tumor Cells in Breast Cancer

NCT02005770 | Completed Phase 4 DMC

• 1 other identifier: 2013-0408
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 2

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.

Conditions

Female Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of CTC before and after administration of anesthetics

  5 days

Study Arms (2)

Sevoflurane

EXPERIMENTAL

General anesthesia using Sevoflurane

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

General anesthesia using propofol TCI

Drug: Propofol

Interventions

Sevoflurane DRUG

Sevoflurane

Propofol DRUG

Propofol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85
• ASA I-III
• Primary breast cancer (TNM stage = T1-3, N0-2, M0)
• Primary surgery
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

University Hospital Zurich, Institute of Anesthesiology

Zurich, Canton of Zurich, CH-8091, Switzerland

Location

Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden

Zurich, 8032, Switzerland

Location

Related Publications (1)

• Hovaguimian F, Braun J, Z'graggen BR, Schlapfer M, Dumrese C, Ewald C, Dedes KJ, Fink D, Rolli U, Seeberger M, Tausch C, Papassotiropoulos B, Puhan MA, Beck-Schimmer B. Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial. Anesthesiology. 2020 Sep;133(3):548-558. doi: 10.1097/ALN.0000000000003409.

  PMID: 32568845 DERIVED

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Beatrice Beck Schimmer, Prof MD

  University Hospital Zurich, Institute of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: March 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

CH (2)