TeMP: 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.

Sponsor
Moscow Clinical Scientific Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04800393
Collaborator
Negovsky Reanimatology Research Institute (Other)
130
1
2
72.1
1.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
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).
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inhalation anesthesia

Drug: Sevoflurane
induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery

Active Comparator: Total intravenous anesthesia

Drug: Propofol
propofol-based total intravenous anesthesia during breast cancer surgery

Outcome Measures

Primary Outcome Measures

  1. Neutrophil-lymphocyte ratio [1 hour after surgery]

    Absolute number of neutrophils divided by the absolute number of lymphocytes

  2. Neutrophil-lymphocyte ratio [24 hours after surgery]

    Absolute number of neutrophils divided by the absolute number of lymphocytes

Secondary Outcome Measures

  1. Matrix metallopeptidase 9 [1 hour after surgery]

    ng/mL

  2. Matrix metallopeptidase 9 [24 hour after surgery]

    ng/mL

  3. C-reactive protein [1 hour after surgery]

    mg/L

  4. C-reactive protein [24 hour after surgery]

    mg/L

  5. Natural killer cells of blood (CD3-CD16 +) [1 hour after surgery]

    Absolute number (х 10^9 /L)

  6. Natural killer cells of blood (CD3-CD16 +) [24 hour after surgery]

    Absolute number (х 10^9 /L)

  7. 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

  8. Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +) [24 hour after surgery]

    the ratio of T helper cells to cytotoxic T cells

  9. IL-6 [1 hour after surgery]

    pg/ml

  10. IL-6 [24 hour after surgery]

    pg/ml

Other Outcome Measures

  1. T cells of blood (CD3 +) [1 hour after surgery]

    Absolute number (х 10 /L)

  2. T cells of blood (CD3 +) [24 hours after surgery]

    Absolute number (х 10^9 /L)

  3. T helpers of blood (CD3 + CD4 +) [1 hour after surgery]

    Absolute number (х 10^9 /L)

  4. T helpers of blood (CD3 + CD4 +) [24 hours after surgery]

    Absolute number (х 10^9 /L)

  5. Cytotoxic T cells of blood (CD3 + CD8 +) [1 hour after surgery]

    Absolute number (х 10^9 /L)

  6. Cytotoxic T cells of blood (CD3 + CD8 +) [24 hours after surgery]

    Absolute number (х 10^9 /L)

  7. B cells of blood (CD19 + CD3-) [1 hour after surgery]

    Absolute number (х 10^9 /L)

  8. B cells of blood (CD19 + CD3-) [24 hour after surgery]

    Absolute number (х 10^9 /L)

  9. T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood [1 hour after surgery]

    percentage

  10. T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood [24 hours after surgery]

    percentage

  11. Phagocytosis [1 hour after surgery]

    percentage

  12. Phagocytosis [24 hours after surgery]

    percentage

  13. IgA [1 hour after surgery]

    g/L

  14. IgA [24 hours after surgery]

    g/L

  15. IgM [1 hour after surgery]

    g/L

  16. IgM [24 hours after surgery]

    g/L

  17. IgG [1 hour after surgery]

    g/L

  18. IgG [24 hours after surgery]

    g/L

  19. Complement component C3 [1 hour after surgery]

    g/L

  20. Complement component C3 [24 hours after surgery]

    g/L

  21. Complement component C4 [1 hour after surgery]

    g/L

  22. Complement component C4 [24 hours after surgery]

    g/L

  23. Overall survival [1 year]

    percentage of survival patients

  24. Overall survival [3 year]

    percentage of survival patients

  25. Overall survival [5 year]

    percentage of survival patients

  26. Disease-free survival [1 year]

    percentage of survival patients

  27. Disease-free survival [3 year]

    percentage of survival patients

  28. Disease-free survival [5 year]

    percentage of survival patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 74 Years
Sexes Eligible for Study:
Female
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moscow Scientific Clinical Center Moscow Russian Federation 111123

Sponsors and Collaborators

  • Moscow Clinical Scientific Center
  • Negovsky Reanimatology Research Institute

Investigators

  • Principal Investigator: Valerii Subbotin, PhD, Moscow Scientific Clinical Center
  • Study Director: Valery Likhvantsev, PhD, Negovsky Reanimatology Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Valerii Subbotin, PhD, Moscow Clinical Scientific Center
ClinicalTrials.gov Identifier:
NCT04800393
Other Study ID Numbers:
  • TeMP 2021
First Posted:
Mar 16, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Valerii Subbotin, PhD, Moscow Clinical Scientific Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022