Anesthesia and Circulating Tumor Cells in Breast Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
221 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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