Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04800393
Status:
RECRUITING
Last Update Posted:
2023-04-26
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'T cells of blood (CD3 +)', 'timeFrame': '1 hour after surgery', 'description': 'Absolute number (х 10 /L)'}, {'measure': 'T cells of blood (CD3 +)', 'timeFrame': '24 hours after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'T helpers of blood (CD3 + CD4 +)', 'timeFrame': '1 hour after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'T helpers of blood (CD3 + CD4 +)', 'timeFrame': '24 hours after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'Cytotoxic T cells of blood (CD3 + CD8 +)', 'timeFrame': '1 hour after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'Cytotoxic T cells of blood (CD3 + CD8 +)', 'timeFrame': '24 hours after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'B cells of blood (CD19 + CD3-)', 'timeFrame': '1 hour after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'B cells of blood (CD19 + CD3-)', 'timeFrame': '24 hour after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood', 'timeFrame': '1 hour after surgery', 'description': 'percentage'}, {'measure': 'T cells (CD3 +) + B cells (CD19 + CD3 -) + Natural killer cells (CD3-CD16 +) of blood', 'timeFrame': '24 hours after surgery', 'description': 'percentage'}, {'measure': 'Phagocytosis', 'timeFrame': '1 hour after surgery', 'description': 'percentage'}, {'measure': 'Phagocytosis', 'timeFrame': '24 hours after surgery', 'description': 'percentage'}, {'measure': 'IgA', 'timeFrame': '1 hour after surgery', 'description': 'g/L'}, {'measure': 'IgA', 'timeFrame': '24 hours after surgery', 'description': 'g/L'}, {'measure': 'IgM', 'timeFrame': '1 hour after surgery', 'description': 'g/L'}, {'measure': 'IgM', 'timeFrame': '24 hours after surgery', 'description': 'g/L'}, {'measure': 'IgG', 'timeFrame': '1 hour after surgery', 'description': 'g/L'}, {'measure': 'IgG', 'timeFrame': '24 hours after surgery', 'description': 'g/L'}, {'measure': 'Complement component C3', 'timeFrame': '1 hour after surgery', 'description': 'g/L'}, {'measure': 'Complement component C3', 'timeFrame': '24 hours after surgery', 'description': 'g/L'}, {'measure': 'Complement component C4', 'timeFrame': '1 hour after surgery', 'description': 'g/L'}, {'measure': 'Complement component C4', 'timeFrame': '24 hours after surgery', 'description': 'g/L'}, {'measure': 'Overall survival', 'timeFrame': '1 year', 'description': 'percentage of survival patients'}, {'measure': 'Overall survival', 'timeFrame': '3 year', 'description': 'percentage of survival patients'}, {'measure': 'Overall survival', 'timeFrame': '5 year', 'description': 'percentage of survival patients'}, {'measure': 'Disease-free survival', 'timeFrame': '1 year', 'description': 'percentage of survival patients'}, {'measure': 'Disease-free survival', 'timeFrame': '3 year', 'description': 'percentage of survival patients'}, {'measure': 'Disease-free survival', 'timeFrame': '5 year', 'description': 'percentage of survival patients'}], 'primaryOutcomes': [{'measure': 'Neutrophil-lymphocyte ratio', 'timeFrame': '1 hour after surgery', 'description': 'Absolute number of neutrophils divided by the absolute number of lymphocytes'}, {'measure': 'Neutrophil-lymphocyte ratio', 'timeFrame': '24 hours after surgery', 'description': 'Absolute number of neutrophils divided by the absolute number of lymphocytes'}], 'secondaryOutcomes': [{'measure': 'Matrix metallopeptidase 9', 'timeFrame': '1 hour after surgery', 'description': 'ng/mL'}, {'measure': 'Matrix metallopeptidase 9', 'timeFrame': '24 hour after surgery', 'description': 'ng/mL'}, {'measure': 'C-reactive protein', 'timeFrame': '1 hour after surgery', 'description': 'mg/L'}, {'measure': 'C-reactive protein', 'timeFrame': '24 hour after surgery', 'description': 'mg/L'}, {'measure': 'Natural killer cells of blood (CD3-CD16 +)', 'timeFrame': '1 hour after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'Natural killer cells of blood (CD3-CD16 +)', 'timeFrame': '24 hour after surgery', 'description': 'Absolute number (х 10\\^9 /L)'}, {'measure': 'Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)', 'timeFrame': '1 hour after surgery', 'description': 'the ratio of T helper cells to cytotoxic T cells'}, {'measure': 'Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)', 'timeFrame': '24 hour after surgery', 'description': 'the ratio of T helper cells to cytotoxic T cells'}, {'measure': 'IL-6', 'timeFrame': '1 hour after surgery', 'description': 'pg/ml'}, {'measure': 'IL-6', 'timeFrame': '24 hour after surgery', 'description': 'pg/ml'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Breast Cancer', 'Phagocyte Cell Dysfunction', 'Immune Suppression', 'Inhalation anesthesia', 'volatile anesthesia', 'total intravenous anesthesia', 'interleukins', 'phagocytosis', 'neutrophil-lymphocyte ratio', 'natural killers', 'oncology'], 'conditions': ['Anesthesia', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nObjective: The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery', 'detailedDescription': '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:\n\n1. Cho J.S. et al., 2017 - 48 patients (PMID: 28924368, TIVA group: NLR = 3.37 ± 1.27; inhalation group: NLR = 3.85 ± 1.46)\n2. Ní Eochagáin A. et al., 2018 - 116 patients (PMID: 29457215, TIVA group: NLR = 3.20 ± 1.37; inhalation group: NLR = 4.10 ± 1.90).\n\nThe pooled mean NLR in the TIVA group is 3.25±1.34, in the inhalation anesthesia group: 4.03±1.78.\n\nDifference 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age of the patients is from 45 to 74 years;\n* Primary operable breast cancer (BC) without prior chemotherapy;\n* Cytologically confirmed breast malignant tumor of IA-IIA stages (T1-2, N0, M0);\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Acute cerebrovascular accident (CVA) occurred in the previous 6 months;\n* Myocardial infarction (MI) occurred in the previous 6 months;\n* Acute arterial thrombosis occurred in the previous 6 months;\n* Acute venous thromboembolism occurred in the previous 6 months;\n* Subarachnoid hemorrhage occurred during the previous 3 months;\n* Chronic kidney disease (CKD) stage 3B-5;\n* Сhronic heart failure (NYHA) class 3-4;\n* Pregnancy;\n* History of another location cancer;\n* History of drug addiction;\n* Autoimmune diseases in history;\n* Post-randomization: withdrawal of informed consent (refusal to continue participating in the study);\n* Post-randomization: surgical intervention, performed not in full (verified non-resected lesions in the early p/o period, 2 weeks p/o).'}, 'identificationModule': {'nctId': 'NCT04800393', 'acronym': 'TeMP', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Moscow Clinical Scientific Center'}, 'officialTitle': '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).', 'orgStudyIdInfo': {'id': 'TeMP 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhalation anesthesia', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total intravenous anesthesia', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery', 'armGroupLabels': ['Inhalation anesthesia']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'propofol-based total intravenous anesthesia during breast cancer surgery', 'armGroupLabels': ['Total intravenous anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111123', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Valerii Subbotin, PhD', 'role': 'CONTACT', 'email': 'subbotin67@mail.ru', 'phone': '+79166122504'}, {'name': 'Kristina Kadantseva, MD', 'role': 'CONTACT', 'email': 'kristina161093@gmail.com', 'phone': '+79168306947'}], 'facility': 'Moscow Scientific Clinical Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Valerii Subbotin, PhD', 'role': 'CONTACT', 'email': 'subbotin67@mail.ru', 'phone': '+79166122504'}, {'name': 'Kristina Kadantseva', 'role': 'CONTACT', 'email': 'kristina161093@gmail.com', 'phone': '+79168306947'}], 'overallOfficials': [{'name': 'Valerii Subbotin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Scientific Clinical Center'}, {'name': 'Valery Likhvantsev, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Negovsky Reanimatology Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Clinical Scientific Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Negovsky Reanimatology Research Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Valerii Subbotin', 'investigatorAffiliation': 'Moscow Clinical Scientific Center'}}}}