Anesthesia, Breast Cancer
Conditions
Keywords
Anesthesia, Breast Cancer, Phagocyte Cell Dysfunction, Immune Suppression, Inhalation anesthesia, volatile anesthesia, total intravenous anesthesia, interleukins, phagocytosis, neutrophil-lymphocyte ratio, natural killers, oncology
Brief summary
Even decade ago it was believed that the choice method of anesthesia did not affect the course of the oncological process, but recent evidence has begun to emerge that inhalation anesthesia vs TIVA is associated with a higher number of adverse outcomes. Apparently, it makes sense to conduct mRCT in order to assess the effect of IA on immune system in patients operated on for breast cancer comprehensively. The results of that kind of RCT may finally give us an answer whether the choice of anesthesia affects the immune status of patients undergoing surgery for breast cancer. The evaluation of complications and long-term survival will allow to recommend to use or not to use IA for this type of surgery. Objective: The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery
Detailed description
The power calculation for this study was based on an assessment of Neutrophil-lymphocyte ratio (NLR) in patients undergoing breast cancer resection with total intravenous and inhalation anesthesia in two studies: 1. Cho J.S. et al., 2017 - 48 patients (PMID: 28924368, TIVA group: NLR = 3.37 ± 1.27; inhalation group: NLR = 3.85 ± 1.46) 2. Ní Eochagáin A. et al., 2018 - 116 patients (PMID: 29457215, TIVA group: NLR = 3.20 ± 1.37; inhalation group: NLR = 4.10 ± 1.90). The pooled mean NLR in the TIVA group is 3.25±1.34, in the inhalation anesthesia group: 4.03±1.78. Difference in means (effect size): 0.78, for level α=0.05, power 1-β=80% and expected standard deviation of 1.5, 65 patients in each group should be recruited, taking into account a 10% margin (total number of patients: 130).
Interventions
DRUGSevoflurane
induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery
DRUGPropofol
propofol-based total intravenous anesthesia during breast cancer surgery
Sponsors
Negovsky Reanimatology Research Institute
Moscow Clinical Scientific Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* The age of the patients is from 45 to 74 years; * Primary operable breast cancer (BC) without prior chemotherapy; * Cytologically confirmed breast malignant tumor of IA-IIA stages (T1-2, N0, M0); * Signed informed consent.
Exclusion criteria
* Acute cerebrovascular accident (CVA) occurred in the previous 6 months; * Myocardial infarction (MI) occurred in the previous 6 months; * Acute arterial thrombosis occurred in the previous 6 months; * Acute venous thromboembolism occurred in the previous 6 months; * Subarachnoid hemorrhage occurred during the previous 3 months; * Chronic kidney disease (CKD) stage 3B-5; * Сhronic heart failure (NYHA) class 3-4; * Pregnancy; * History of another location cancer; * History of drug addiction; * Autoimmune diseases in history; * Post-randomization: withdrawal of informed consent (refusal to continue participating in the study); * Post-randomization: surgical intervention, performed not in full (verified non-resected lesions in the early p/o period, 2 weeks p/o).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil-lymphocyte ratio | 1 hour after surgery | Absolute number of neutrophils divided by the absolute number of lymphocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Matrix metallopeptidase 9 | 1 hour after surgery | ng/mL |
| C-reactive protein | 1 hour after surgery | mg/L |
| Natural killer cells of blood (CD3-CD16 +) | 1 hour after surgery | Absolute number (х 10\^9 /L) |
| Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +) | 1 hour after surgery | the ratio of T helper cells to cytotoxic T cells |
| IL-6 | 1 hour after surgery | pg/ml |
Other
| Measure | Time frame | Description |
|---|---|---|
| IgA | 1 hour after surgery | g/L |
| IgM | 1 hour after surgery | g/L |
| IgG | 1 hour after surgery | g/L |
| T cells of blood (CD3 +) | 1 hour after surgery | Absolute number (х 10 /L) |
| Complement component C4 | 1 hour after surgery | g/L |
| Overall survival | 1 year | percentage of survival patients |
| Disease-free survival | 1 year | percentage of survival patients |
| Complement component C3 | 1 hour after surgery | g/L |
| T helpers of blood (CD3 + CD4 +) | 1 hour after surgery | Absolute number (х 10\^9 /L) |
| Cytotoxic T cells of blood (CD3 + CD8 +) | 1 hour after surgery | Absolute number (х 10\^9 /L) |
| B cells of blood (CD19 + CD3-) | 1 hour after surgery | Absolute number (х 10\^9 /L) |
| T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood | 1 hour after surgery | percentage |
| Phagocytosis | 1 hour after surgery | percentage |
Countries
Russia
Contacts
Primary ContactValerii Subbotin, PhD
Backup ContactKristina Kadantseva
Outcome results
None listed