Anesthesia and Circulating Tumor Cells in Breast Cancer | NCT02005770

Studies
Anesthesia and Circulating Tumor Cells in Breast Cancer

NCT02005770

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Apr 14, 2020Actual

Enrollment

221Actual

Phase

Phase 4

Conditions

Female Breast Carcinoma

Interventions

Sevoflurane
Propofol

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Dec 3, 2013

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2020

Last Update Posted Date

Apr 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

221Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Experimental	General anesthesia using Sevoflurane	Drug: Sevoflurane
Propofol	Active Comparator	General anesthesia using propofol TCI	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug		Sevoflurane
Propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of CTC before and after administration of anesthetics		5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beatrice Beck Schimmer, Prof MD	University Hospital Zurich, Institute of Anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Institute of Anesthesiology		Zurich	Canton of Zurich	CH-8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32568845	Derived	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.

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated