GENe EXpression After Regional or General ANesthesia in Patients Undergoing Breast Cancer Surgery

NCT03779685 | Unknown

• 1 other identifier: GENEXAN
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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. Standard anesthetic procedures for the surgery of breast cancer include general and regional anesthesia 2. Growing preclinical and clinical data support the hypothesis that anesthetic choice may affect cancer-related outcomes. Recurrence in breast cancer was reduced to four-fold in a retrospective study with a 2.5 to 4 year follow up 3. Recurrence and metastasis-free survival, with multivariate analysis, was 94% (95% CI 87,100) versus 82% (74, 91) at 24 months, and 94 (87, 100) versus 77 (68, 87) at 36 months in the paravertebral and general anesthesia patients, respectively, (p=0.013). Currently large confirmatory randomized trials evaluating breast cancer recurrence in patients operated with general or regional anesthesia are yet undergoing 4.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• Whole genome expression by microarray

  tumor, biopsy, normal wound tissue

  before tumor excision

• Whole genome expression by mircoarray

  tumor, wound tissue

  during surgery (just after tumor excision)

Secondary Outcomes (6)

• Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII

  before tumor excision

• cancer recurrence

  each 6 months for up to 7 years

• survival from cancer

  each 6 months for up to 7 years

• Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII

  at the end of surgery

• Immune progenitors (MDBCs, GMPs, HPSCs), Natural Killer, T regulatory Lymphocytes, PentraxinIII

  at 24 hours

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

Breast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print)

Procedure: General anesthesia

Regional anesthesia

EXPERIMENTAL

Breast cancer surgery (Tumor Stage 1-3, Nodes 0-2 as determined according to the NCI stage definitions http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page3/print)

Procedure: Regional anesthesia

Interventions

General anesthesia PROCEDURE

Sevoflurane and morphine

General anesthesia

Regional anesthesia PROCEDURE

Paravertebral block

Regional anesthesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera San Gerardo di Monza: lead

MeSH Terms

Interventions

Anesthesia, General; Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 19, 2018
• Study Start: March 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share