Comparing inhalation and intravenous anesthesia effects on immune status in breast cancer surgery
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).
This study is testing whether using inhalation anesthesia or intravenous anesthesia during breast cancer surgery affects the immune system and survival rates in patients aged 45 to 74.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 45 Years to 74 Years |
| Sex | Female |
| Sponsor | Moscow Clinical Scientific Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT04800393 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of inhalation anesthesia versus total intravenous anesthesia on the immune system and mortality rates in patients undergoing surgery for breast cancer. It aims to determine whether the choice of anesthesia influences immune responses and long-term survival outcomes. The study will recruit 130 patients aged 45 to 74 with operable breast cancer, assessing their neutrophil-lymphocyte ratio as a key indicator of immune status. Participants will be randomly assigned to receive either sevoflurane or propofol anesthesia, with outcomes evaluated post-surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 45 to 74 with primary operable breast cancer at IA-IIA stages without prior chemotherapy.
Not a fit: Patients with recent cardiovascular events, chronic kidney disease, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing anesthesia choices to improve immune function and survival rates in breast cancer patients.
How similar studies have performed: Previous studies have suggested potential differences in outcomes based on anesthesia type, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Moscow
- Moscow Scientific Clinical Center — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Valerii Subbotin, PhD — Moscow Scientific Clinical Center
- Study coordinator: Valerii Subbotin, PhD
- Email: subbotin67@mail.ru
- Phone: +79166122504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.