Anesthesia and Circulating Tumor Cells in Breast Cancer

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005770

Enrollment

221

Registered

2013-12-09

Start date

2014-03-31

Completion date

2018-04-30

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Breast Carcinoma

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.

Interventions

DRUGSevoflurane

DRUGPropofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026