Status:
UNKNOWN
GENe EXpression After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery
Lead Sponsor:
Azienda Ospedaliera San Gerardo di Monza
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
Breast cancer is the most commonly diagnosed cancer in females and the second leading cause of death from cancer in women. It was estimated that 2 million new cases have occurred in 2018 worldwide 1. ...
Detailed Description
Background: Exposure to general or regional anesthesia, can modulate differently breast cancer biology through a direct activity on cancer cells or indirectly through modifications in host response (i...
Eligibility Criteria
Inclusion
- Women 18-85 years old
- No undergoing pregnancy
- ASA Score I-IV
- Patients scheduled for breast surgery
- No contraindications (including surgical) to regional (paravertebral) anesthesia
- No previous breast surgery
- No known hereditary or familial cancer syndromes
- No previous cancer anamnesis, radio o chemiotherapy
- Primary breast cancer with Tumor classification 1-3, Nodes 0-2 as determined
- according to the NCI stage definitions (Primary breast cancer without known extension beyond the breast and axillary nodes)
- Free from pain in preoperative period
- Patients who don't use analgesic drugs before surgery
- Patients without cognitive impairment or mental retardation
Exclusion
- Women \> 18, \< 85 years old
- Pregnancy
- ASA Score \> IV
- Previous breast surgery
- Contraindications to regional anesthesia
- Known hereditary or familial cancer syndromes
- Previous cancer anamnesis, radio or chemiotherapy
- Tumor classification \> 3, Nodes \> 2, M \> 0 as determined according to the NCI stage
- definitions
- Pain in preoperative period
- Use of analgesic drugs before surgery
- Cognitive impairment or mental retardation
- Patients who did not gave a written informed consent
- Undergoing therapy with alpha (doxazosin) or beta blockers.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03779685
Start Date
March 1 2021
End Date
March 1 2022
Last Update
August 5 2020
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