Back to resultsAnesthesia and Circulating Tumor Cells in Breast Cancer
Primary Purpose
Female Breast Carcinoma
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Female Breast Carcinoma
Eligibility 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
Sites / Locations
- University Hospital Zurich, Institute of Anesthesiology
- Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sevoflurane
Propofol
Arm Description
General anesthesia using Sevoflurane
General anesthesia using propofol TCI
Outcomes
Primary Outcome Measures
Number of CTC before and after administration of anesthetics
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02005770
Brief Title
Anesthesia and Circulating Tumor Cells in Breast Cancer
Official Title
Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Breast Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
General anesthesia using Sevoflurane
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
General anesthesia using propofol TCI
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Primary Outcome Measure Information:
Title
Number of CTC before and after administration of anesthetics
Time Frame
5 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice Beck Schimmer, Prof MD
Organizational Affiliation
University Hospital Zurich, Institute of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Institute of Anesthesiology
City
Zurich
State/Province
ZH
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Institute of Physicians for Anesthesia and Intensive Care Klinik Hirslanden
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
32568845
Citation
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.
Results Reference
derived
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Anesthesia and Circulating Tumor Cells in Breast Cancer
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