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
1 other identifier
interventional
130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
March 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
ExpectedApril 26, 2023
April 1, 2023
1.3 years
March 12, 2021
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neutrophil-lymphocyte ratio
Absolute number of neutrophils divided by the absolute number of lymphocytes
1 hour after surgery
Neutrophil-lymphocyte ratio
Absolute number of neutrophils divided by the absolute number of lymphocytes
24 hours after surgery
Secondary Outcomes (10)
Matrix metallopeptidase 9
1 hour after surgery
Matrix metallopeptidase 9
24 hour after surgery
C-reactive protein
1 hour after surgery
C-reactive protein
24 hour after surgery
Natural killer cells of blood (CD3-CD16 +)
1 hour after surgery
- +5 more secondary outcomes
Other Outcomes (28)
T cells of blood (CD3 +)
1 hour after surgery
T cells of blood (CD3 +)
24 hours after surgery
T helpers of blood (CD3 + CD4 +)
1 hour after surgery
- +25 more other outcomes
Study Arms (2)
Inhalation anesthesia
EXPERIMENTALTotal intravenous anesthesia
ACTIVE COMPARATORInterventions
induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery
propofol-based total intravenous anesthesia during breast cancer surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moscow Scientific Clinical Center
Moscow, 111123, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerii Subbotin, PhD
Moscow Scientific Clinical Center
- STUDY DIRECTOR
Valery Likhvantsev, PhD
Negovsky Reanimatology Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 12, 2021
First Posted
March 16, 2021
Study Start
March 29, 2022
Primary Completion
July 1, 2023
Study Completion (Estimated)
April 1, 2028
Last Updated
April 26, 2023
Record last verified: 2023-04