AnesthesiaTeMPNCT04800393
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.
A study testing Sevoflurane and Propofol in people with Anesthesia and Breast Cancer, run by Moscow Clinical Scientific Center at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, women only
- Conditions the study is for
- Anesthesia, Breast Cancer
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- 29 Mar 2022to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Moscow Scientific Clinical Center
Moscow, 111123
Valerii Subbotin, PhD, +79166122504, subbotin67@mail.ru
Kristina Kadantseva, MD, +79168306947, kristina161093@gmail.com
About this study
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).
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
Read the 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).
- Conditions
- Anesthesia, Breast Cancer
- Being tested
- Sevoflurane, Propofol
- Keywords
- Anesthesia, Breast Cancer, Phagocyte Cell Dysfunction, Immune Suppression, Inhalation anesthesia, volatile anesthesia, total intravenous anesthesia, interleukins, phagocytosis, neutrophil-lymphocyte ratio, natural killers, oncology
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery
PropofolDrug
propofol-based total intravenous anesthesia during breast cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Inhalation anesthesia | Experimental | Not described Receives: Drug: Sevoflurane |
| Total intravenous anesthesia | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-lymphocyte ratio
Absolute number of neutrophils divided by the absolute number of lymphocytes
Measured: 1 hour after surgery
Neutrophil-lymphocyte ratio
Absolute number of neutrophils divided by the absolute number of lymphocytes
Measured: 24 hours after surgery
Secondary outcomes (10)
Matrix metallopeptidase 9
ng/mL
Measured: 1 hour after surgery
Matrix metallopeptidase 9
ng/mL
Measured: 24 hour after surgery
C-reactive protein
mg/L
Measured: 1 hour after surgery
C-reactive protein
mg/L
Measured: 24 hour after surgery
Natural killer cells of blood (CD3-CD16 +)
Absolute number (х 10^9 /L)
Measured: 1 hour after surgery
Natural killer cells of blood (CD3-CD16 +)
Absolute number (х 10^9 /L)
Measured: 24 hour after surgery
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
the ratio of T helper cells to cytotoxic T cells
Measured: 1 hour after surgery
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
the ratio of T helper cells to cytotoxic T cells
Measured: 24 hour after surgery
IL-6
pg/ml
Measured: 1 hour after surgery
IL-6
pg/ml
Measured: 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start29 Mar 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Collaborators
- Negovsky Reanimatology Research Institute
- Responsible party
- Principal investigator, Valerii Subbotin, Moscow Clinical Scientific Center
- Investigators
- Valerii Subbotin, PhD, Principal investigator, Moscow Scientific Clinical CenterValery Likhvantsev, PhD, Study director, Negovsky Reanimatology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800393
- Sponsor's protocol ID
- TeMP 2021
- Acronym
- TeMP
- Status last verified
- Apr 2023
- First submitted
- 12 Mar 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04800393
- Acronym / sponsor ID
- TeMP / TeMP 2021
- Conditions
- Anesthesia, Breast Cancer
- Keywords
- Anesthesia, Breast Cancer, Phagocyte Cell Dysfunction, Immune Suppression, Inhalation anesthesia, volatile anesthesia, total intravenous anesthesia, interleukins
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Collaborators
- Negovsky Reanimatology Research Institute
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalation anesthesia | Experimental | Drug: Sevoflurane |
| Total intravenous anesthesia | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevofluraneinduction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery | Drug | Inhalation anesthesia |
| Propofolpropofol-based total intravenous anesthesia during breast cancer surgery | Drug | Total intravenous anesthesia |
Primary outcome
Neutrophil-lymphocyte ratio
Time frame: 1 hour after surgery
Absolute number of neutrophils divided by the absolute number of lymphocytes
Neutrophil-lymphocyte ratio
Time frame: 24 hours after surgery
Absolute number of neutrophils divided by the absolute number of lymphocytes
10 secondary outcomes
Matrix metallopeptidase 9
Time frame: 1 hour after surgery
Matrix metallopeptidase 9
Time frame: 24 hour after surgery
C-reactive protein
Time frame: 1 hour after surgery
C-reactive protein
Time frame: 24 hour after surgery
Natural killer cells of blood (CD3-CD16 +)
Time frame: 1 hour after surgery
Natural killer cells of blood (CD3-CD16 +)
Time frame: 24 hour after surgery
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
Time frame: 1 hour after surgery
Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)
Time frame: 24 hour after surgery
IL-6
Time frame: 1 hour after surgery
IL-6
Time frame: 24 hour after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valerii Subbotin, PhD principal investigator
Moscow Scientific Clinical Center
Valery Likhvantsev, PhD study director
Negovsky Reanimatology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Propofol in people with Anesthesia and Breast Cancer, run by Moscow Clinical Scientific Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerii Subbotin, PhD (+79166122504, subbotin67@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-lymphocyte ratio (time frame: 1 hour after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.