Anesthesia and Circulating Tumor Cells in Breast Cancer

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT02005770

Collaborator

(none)

221

Enrollment

Locations

Arms

Actual Duration (Months)

110.5

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Female Breast Carcinoma	Drug: Sevoflurane Drug: Propofol	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

221 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevoflurane General anesthesia using Sevoflurane	Drug: Sevoflurane
Active Comparator: Propofol General anesthesia using propofol TCI	Drug: Propofol

Arm

Intervention/Treatment

Experimental: Sevoflurane

General anesthesia using Sevoflurane

Drug: Sevoflurane

Active Comparator: Propofol

General anesthesia using propofol TCI

Drug: Propofol

Outcome Measures

Primary Outcome Measures

Number of CTC before and after administration of anesthetics [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Institute of Anesthesiology	Zurich	ZH	Switzerland	CH-8091
2	Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden	Zurich		Switzerland	8032