The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial.

Breast Cancer Clinical Trial

— TeMP  

Official title:

The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial (TeMP - Trial).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800393
• Other study ID #: TeMP 2021
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: April 1, 2028

Study information

• Verified date: April 2023
• Source: Moscow Clinical Scientific Center
• Contact: Valerii Subbotin, PhD
• Phone: +79166122504
• Email: subbotin67[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: April 1, 2028
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 74 Years

Eligibility

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;

• ?hronic 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).

Related Conditions & MeSH terms

• Anesthesia
• Breast Cancer
• Breast Neoplasms
• Respiratory Aspiration

Intervention

Drug:
• Sevoflurane
induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery
• Propofol
propofol-based total intravenous anesthesia during breast cancer surgery

Locations

Country	Name	City	State
Russian Federation	Moscow Scientific Clinical Center	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Moscow Clinical Scientific Center	Negovsky Reanimatology Research Institute

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T cells of blood (CD3 +)	Absolute number (? 10 /L)	1 hour after surgery
Other	T cells of blood (CD3 +)	Absolute number (? 10^9 /L)	24 hours after surgery
Other	T helpers of blood (CD3 + CD4 +)	Absolute number (? 10^9 /L)	1 hour after surgery
Other	T helpers of blood (CD3 + CD4 +)	Absolute number (? 10^9 /L)	24 hours after surgery
Other	Cytotoxic T cells of blood (CD3 + CD8 +)	Absolute number (? 10^9 /L)	1 hour after surgery
Other	Cytotoxic T cells of blood (CD3 + CD8 +)	Absolute number (? 10^9 /L)	24 hours after surgery
Other	B cells of blood (CD19 + CD3-)	Absolute number (? 10^9 /L)	1 hour after surgery
Other	B cells of blood (CD19 + CD3-)	Absolute number (? 10^9 /L)	24 hour after surgery
Other	T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood	percentage	1 hour after surgery
Other	T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood	percentage	24 hours after surgery
Other	Phagocytosis	percentage	1 hour after surgery
Other	Phagocytosis	percentage	24 hours after surgery
Other	IgA	g/L	1 hour after surgery
Other	IgA	g/L	24 hours after surgery
Other	IgM	g/L	1 hour after surgery
Other	IgM	g/L	24 hours after surgery
Other	IgG	g/L	1 hour after surgery
Other	IgG	g/L	24 hours after surgery
Other	Complement component C3	g/L	1 hour after surgery
Other	Complement component C3	g/L	24 hours after surgery
Other	Complement component C4	g/L	1 hour after surgery
Other	Complement component C4	g/L	24 hours after surgery
Other	Overall survival	percentage of survival patients	1 year
Other	Overall survival	percentage of survival patients	3 year
Other	Overall survival	percentage of survival patients	5 year
Other	Disease-free survival	percentage of survival patients	1 year
Other	Disease-free survival	percentage of survival patients	3 year
Other	Disease-free survival	percentage of survival patients	5 year
Primary	Neutrophil-lymphocyte ratio	Absolute number of neutrophils divided by the absolute number of lymphocytes	1 hour after surgery
Primary	Neutrophil-lymphocyte ratio	Absolute number of neutrophils divided by the absolute number of lymphocytes	24 hours after surgery
Secondary	Matrix metallopeptidase 9	ng/mL	1 hour after surgery
Secondary	Matrix metallopeptidase 9	ng/mL	24 hour after surgery
Secondary	C-reactive protein	mg/L	1 hour after surgery
Secondary	C-reactive protein	mg/L	24 hour after surgery
Secondary	Natural killer cells of blood (CD3-CD16 +)	Absolute number (? 10^9 /L)	1 hour after surgery
Secondary	Natural killer cells of blood (CD3-CD16 +)	Absolute number (? 10^9 /L)	24 hour after surgery
Secondary	Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)	the ratio of T helper cells to cytotoxic T cells	1 hour after surgery
Secondary	Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)	the ratio of T helper cells to cytotoxic T cells	24 hour after surgery
Secondary	IL-6	pg/ml	1 hour after surgery
Secondary	IL-6	pg/ml	24 hour after surgery