Back to resultsThe 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)
Primary Purpose
Anesthesia, Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia focused on measuring Anesthesia, Breast Cancer, Phagocyte Cell Dysfunction, Immune Suppression, Inhalation anesthesia, volatile anesthesia, total intravenous anesthesia, interleukins, phagocytosis, neutrophil-lymphocyte ratio, natural killers, oncology
Eligibility Criteria
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).
Sites / Locations
- Moscow Scientific Clinical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inhalation anesthesia
Total intravenous anesthesia
Arm Description
Outcomes
Primary Outcome Measures
Neutrophil-lymphocyte ratio
Absolute number of neutrophils divided by the absolute number of lymphocytes
Neutrophil-lymphocyte ratio
Absolute number of neutrophils divided by the absolute number of lymphocytes
Secondary Outcome Measures
Matrix metallopeptidase 9
ng/mL
Matrix metallopeptidase 9
ng/mL
C-reactive protein
mg/L
C-reactive protein
mg/L
Natural killer cells of blood (CD3-CD16 +)
Absolute number (х 10^9 /L)
Natural killer cells of blood (CD3-CD16 +)
Absolute number (х 10^9 /L)
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
the ratio of T helper cells to cytotoxic T cells
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
the ratio of T helper cells to cytotoxic T cells
IL-6
pg/ml
IL-6
pg/ml
Full Information
NCT ID
NCT04800393
First Posted
March 12, 2021
Last Updated
April 25, 2023
Sponsor
Moscow Clinical Scientific Center
Collaborators
Negovsky Reanimatology Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04800393
Brief 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.
Acronym
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).
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Moscow Clinical Scientific Center
Collaborators
Negovsky Reanimatology Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Cho J.S. et al., 2017 - 48 patients (PMID: 28924368, TIVA group: NLR = 3.37 ± 1.27; inhalation group: NLR = 3.85 ± 1.46)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Breast Cancer
Keywords
Anesthesia, Breast Cancer, Phagocyte Cell Dysfunction, Immune Suppression, Inhalation anesthesia, volatile anesthesia, total intravenous anesthesia, interleukins, phagocytosis, neutrophil-lymphocyte ratio, natural killers, oncology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inhalation anesthesia
Arm Type
Experimental
Arm Title
Total intravenous anesthesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
propofol-based total intravenous anesthesia during breast cancer surgery
Primary Outcome Measure Information:
Title
Neutrophil-lymphocyte ratio
Description
Absolute number of neutrophils divided by the absolute number of lymphocytes
Time Frame
1 hour after surgery
Title
Neutrophil-lymphocyte ratio
Description
Absolute number of neutrophils divided by the absolute number of lymphocytes
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Matrix metallopeptidase 9
Description
ng/mL
Time Frame
1 hour after surgery
Title
Matrix metallopeptidase 9
Description
ng/mL
Time Frame
24 hour after surgery
Title
C-reactive protein
Description
mg/L
Time Frame
1 hour after surgery
Title
C-reactive protein
Description
mg/L
Time Frame
24 hour after surgery
Title
Natural killer cells of blood (CD3-CD16 +)
Description
Absolute number (х 10^9 /L)
Time Frame
1 hour after surgery
Title
Natural killer cells of blood (CD3-CD16 +)
Description
Absolute number (х 10^9 /L)
Time Frame
24 hour after surgery
Title
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
Description
the ratio of T helper cells to cytotoxic T cells
Time Frame
1 hour after surgery
Title
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
Description
the ratio of T helper cells to cytotoxic T cells
Time Frame
24 hour after surgery
Title
IL-6
Description
pg/ml
Time Frame
1 hour after surgery
Title
IL-6
Description
pg/ml
Time Frame
24 hour after surgery
Other Pre-specified Outcome Measures:
Title
T cells of blood (CD3 +)
Description
Absolute number (х 10 /L)
Time Frame
1 hour after surgery
Title
T cells of blood (CD3 +)
Description
Absolute number (х 10^9 /L)
Time Frame
24 hours after surgery
Title
T helpers of blood (CD3 + CD4 +)
Description
Absolute number (х 10^9 /L)
Time Frame
1 hour after surgery
Title
T helpers of blood (CD3 + CD4 +)
Description
Absolute number (х 10^9 /L)
Time Frame
24 hours after surgery
Title
Cytotoxic T cells of blood (CD3 + CD8 +)
Description
Absolute number (х 10^9 /L)
Time Frame
1 hour after surgery
Title
Cytotoxic T cells of blood (CD3 + CD8 +)
Description
Absolute number (х 10^9 /L)
Time Frame
24 hours after surgery
Title
B cells of blood (CD19 + CD3-)
Description
Absolute number (х 10^9 /L)
Time Frame
1 hour after surgery
Title
B cells of blood (CD19 + CD3-)
Description
Absolute number (х 10^9 /L)
Time Frame
24 hour after surgery
Title
T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood
Description
percentage
Time Frame
1 hour after surgery
Title
T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood
Description
percentage
Time Frame
24 hours after surgery
Title
Phagocytosis
Description
percentage
Time Frame
1 hour after surgery
Title
Phagocytosis
Description
percentage
Time Frame
24 hours after surgery
Title
IgA
Description
g/L
Time Frame
1 hour after surgery
Title
IgA
Description
g/L
Time Frame
24 hours after surgery
Title
IgM
Description
g/L
Time Frame
1 hour after surgery
Title
IgM
Description
g/L
Time Frame
24 hours after surgery
Title
IgG
Description
g/L
Time Frame
1 hour after surgery
Title
IgG
Description
g/L
Time Frame
24 hours after surgery
Title
Complement component C3
Description
g/L
Time Frame
1 hour after surgery
Title
Complement component C3
Description
g/L
Time Frame
24 hours after surgery
Title
Complement component C4
Description
g/L
Time Frame
1 hour after surgery
Title
Complement component C4
Description
g/L
Time Frame
24 hours after surgery
Title
Overall survival
Description
percentage of survival patients
Time Frame
1 year
Title
Overall survival
Description
percentage of survival patients
Time Frame
3 year
Title
Overall survival
Description
percentage of survival patients
Time Frame
5 year
Title
Disease-free survival
Description
percentage of survival patients
Time Frame
1 year
Title
Disease-free survival
Description
percentage of survival patients
Time Frame
3 year
Title
Disease-free survival
Description
percentage of survival patients
Time Frame
5 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerii Subbotin, PhD
Phone
+79166122504
Email
subbotin67@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Kadantseva
Phone
+79168306947
Email
kristina161093@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerii Subbotin, PhD
Organizational Affiliation
Moscow Scientific Clinical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valery Likhvantsev, PhD
Organizational Affiliation
Negovsky Reanimatology Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Moscow Scientific Clinical Center
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerii Subbotin, PhD
Phone
+79166122504
Email
subbotin67@mail.ru
First Name & Middle Initial & Last Name & Degree
Kristina Kadantseva, MD
Phone
+79168306947
Email
kristina161093@gmail.com
12. IPD Sharing Statement
Learn more about this trial
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.
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