Anesthesia and Circulating Tumor Cells in Breast Cancer

Female Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005770
• Other study ID #: 2013-0408
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: April 2018

Study information

• Verified date: April 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Female Breast Carcinoma
• Neoplastic Cells, Circulating

Intervention

Drug:
• Sevoflurane

• Propofol

Locations

Country	Name	City	State
Switzerland	Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden	Zurich
Switzerland	University Hospital Zurich, Institute of Anesthesiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CTC before and after administration of anesthetics		5 days