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Trial Title:
Effect of Propofol and Sevoflurane Anesthesia on HSP70 Expression in Tumor Cells
NCT ID:
NCT06626711
Condition:
Anesthesia
Cancer Recurrence
Cancer
Conditions: Official terms:
Recurrence
Propofol
Sevoflurane
Conditions: Keywords:
Cancer
Anesthesia
Sevoflurane
Propofol
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Propofol
Description:
Propofol as a part of total venous anesthesia
Arm group label:
Propofol-based total venous anesthesia group
Intervention type:
Drug
Intervention name:
Sevoflurane
Description:
Sevoflurane as a part of intravenous anesthesia
Arm group label:
Sevoflurane-based inhalational anesthesia group
Summary:
The goal of this clinical trial is to learn if sevoflurane-based inhalational anesthesia
(s-IA) and propofol-based total intravenous anesthesia (p-TVA) have different effects on
HSP70 expression in different types of tumour cells. The main questions it aims to answer
are:
- if p-TVA/s-IA increase or suppress HSP70 expression in tumor cells in comparison
with a pre-anesthesia level;
- does this change in HSP70 expression cause any difference in vital characteristics
of tumor cells, such as proliferation, apoptosis, colony formation and migration.
Researchers will compare p-TVA with s-IA by ability of these types of anesthesia to
change the HSP70 expression level and modulate HSP70-mediated effects in tumor cells.
Participants will:
- be randomly allocated to p-TVA or s-IA groups;
- donate 12 ml of blood before anesthesia induction and 12 ml after 2 hours of
anesthesia.
The blood serum will be used to prepare cell medium. After exposure to this medium, cells
from different tumor types will be investigated using cytological and molecular
biological methods.
Detailed description:
This study will be conducted in adult cancer patients who undergo planned radical or
palliative tumor resection and signed informed consent. Patients with diabetes mellitus,
HIV, hepatitis B and C, as well as patients who undergo emergency surgery will not be
included to the study. Patients will be randomly allocated to propofol-based TVA (p-TVA)
and sevoflurane-based IA (s-IA) groups. After the collection of blood before the
anesthesia induction and in 2 hours of anesthesia, probes will be centrifuged to prepare
serum. Cell medium will contain 50% of blood serum. Different tumor cell lines (human
lung adenocarcinoma A549, large cell lung carcinoma NCI-H460, human colorectal
adenocarcinoma DLD1) will be exposed to the cell medium for 4 hours what corresponds to
an approximate duration of anesthesia for oncology surgery. HSP70 expression level will
be determined using SDS-PAGE (polyacrilamide gel electrophoresis) and Western-blot
analysis (intracellular HSP70 content), ELISA of cell medium (extracellular HSP70
expression) and confocal microscopy.
The A549 cell line with stable knockdown of HSP70 developed by shRNA will be used to
distinguish HSP70-based effects of cell medium from p-TVA and s-IA groups on vital
characteristics of tumor cells, including proliferation (MTT assay), apoptosis (LDH
cytotoxicity assay), colony formation and migration (the Wound healing assay).
Researchers will compare HSP70 expression levels and vital characteristics of tumor cells
exposed to patient serum before and after each type of anesthesia, as well as p-TVA group
with s-IA group.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed malignant neoplasm
- Planned surgery for radical or palliative tumor resection
- Age over 18 years
- Signed informed consent
Exclusion Criteria:
- Diabetes mellitus type 2
- HIV, hepatitis B or C
- Emergency surgery
- Known or suspected allergy to studied drugs
- Other conditions when one of the types of anesthesia is more preferable (hemodynamic
disorders, bronchial asthma etc)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Saint Petersburg State University
Address:
City:
Saint Petersburg
Zip:
1999034
Country:
Russian Federation
Contact:
Last name:
Elizaveta Leonova
Phone:
89538016806
Email:
eliz.leonova@gmail.com
Investigator:
Last name:
Sergey M Efremov, MD, PhD, Dr.Sci.Med.
Email:
Principal Investigator
Investigator:
Last name:
Elizaveta Leonova
Email:
Sub-Investigator
Investigator:
Last name:
Elena Mikhaylova, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Daria Marchenko
Email:
Sub-Investigator
Investigator:
Last name:
Irina Guzhova, PhD, Dr.Sci.Biol.
Email:
Sub-Investigator
Investigator:
Last name:
Boris Margulis, PhD, Dr.Sci.Biol.
Email:
Sub-Investigator
Start date:
October 10, 2024
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Saint Petersburg State University, Russia
Agency class:
Other
Collaborator:
Agency:
Institute of Cytology of the Russian Academy of Sciences
Agency class:
Other
Source:
Saint Petersburg State University, Russia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06626711
