Colorectal CancerPhase 1NCT04162535
Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery
A Phase 1 study testing Lidocaine 1% Injectable Solution, Blood extraction and Sevoflurane in people with Colorectal Cancer, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Lidocaine 1% Injectable Solution, Blood extraction and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- 26 Nov 2018to 31 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 80 years old patients admitted for elective colorectal surgery
Who cannot join
- Pre-existing chronic pain
- Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids
- Contraindications to any of the medications in the study
- Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)
- Hepatic (ALT and / or AST> 2 normal wave) or renal (serum creatinine> 2 mg / dl)
- Convulsive conditions that require medication in the last 2 years
Show all 10Show fewer
- Planned regional analgesia and / or anesthesia (spinal or epidural)
- Corticosteroid-dependent asthma
- Autoimmune disorders
- Antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor
Cluj-Napoca, Cluj, 400469
Alexandru Alexa, +40752691911, alexandru_reziati@yahoo.com
About this study
Official title: Contributions to the Elucidation of the Mechanisms and Effects by Which Certain Perianesthetic Interventions Modify Long-term Evolution of Patients With Digestive Cancers Subjected to Surgery
Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.
- Conditions
- Colorectal Cancer
- Being tested
- Lidocaine 1% Injectable Solution, Blood extraction, Sevoflurane, Propofol
- Keywords
- Anesthesia, Propofol, Sevoflurane, Lidocaine, Cell Culture
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1% Injectable SolutionDrug
Also called Antiarrythmic drug
Lidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm
- Induction: 1.5 mg / kg i.v. bolus before induction (at the vein catch).
- Maintaining anesthesia: continuous infusion with Lidocaine 2 mg / kg / h, up to a maximum of 200 mg / h during maintenance (after IOT until waking)
- Infusion with 1% Lidocaine will be reduced to 1.0- 1.5 mg / kg / hour, max 100 mg / hour, for the first 48 hours postop
Blood extractionBiological
Also called Biologic Human Blood
The patients will donate after consent 10 ml of blood prior and after surgery for further study
SevofluraneDrug
Also called Volatile Anesthetic Drug
Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
PropofolDrug
Also called Intravenous Anesthetic Drug
Patients will receive a general anesthesia with Propofol as anesthetic agent
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent Receives: Biological: Blood extraction; Drug: Sevoflurane |
| Total intravenous anesthesia | Experimental | Patients will receive a general anesthesia with Propofol as anesthetic agent Receives: Biological: Blood extraction; Drug: Propofol |
| Total intravenous anesthesia and Lidocaine | Experimental | Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol Receives: Drug: Lidocaine 1% Injectable Solution; Biological: Blood extraction |
| Placebo | No intervention | 10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the antiproliferative and apoptotic effects of anesthetic agents
The investigators aim to correlate the anticancer effects of two anesthetic techniques with tumor markers (p53;p38) and cell proteins involved in proliferation or apoptosis (IGFR;Bcl-2;Bcl-6).
The investigators will report if the anesthetic agent used in cancer surgery influences the serologic values of these markers.
Measured: up to 4 years
Evaluation of patients serum on cell culture
The investigators will investigate the serum of the patients who received different types of anesthesia (elective colorectal cancer surgery) by incubating it with colon cell lines (HCT116). The investigators will concentrate on cell proliferation assay.
The investigators aim to discover how the growth of HCT116 will be influenced by patients' serum in terms of rate of proliferation. The measurements which will be used are Inhibitory Concentration (IC50) measured at 0 , 24 and 48 hours after incubation.
The concentrations will be measured in mcg/ml.
Measured: up to 1 week
Secondary outcomes (2)
Lidocaine concentration
The investigators aim to determine de plasmatic concentration of lidocaine in the patients serum , which have received lidocaine perioperatively.
The investigators will do a Mass-Spec analysis of lidocaine
Measured: up to 4 years
Survival Comparison
The investigators will do a follow up for the patients in all the 3 groups. The investigators want to investigate the survival ratio for the patients that had a elective colorectal cancer surgery.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start26 Nov 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Prof. Dr. I. Chiricuta Institute of Oncology
- Responsible party
- Principal investigator, Alexandru Alexa, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Ionescu Daniela, MD PHD DEEA, Study director, UMF Iuliu Hatieganu Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162535
- Sponsor's protocol ID
- 418/14.11.2018
- Status last verified
- Feb 2021
- First submitted
- 13 Oct 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contributions to the Elucidation of the Mechanisms and Effects by Which Certain Perianesthetic Interventions Modify Long-term Evolution of Patients With Digestive Cancers Subjected to Surgery
- ClinicalTrials.gov ID
- NCT04162535
- Acronym / sponsor ID
- 418/14.11.2018
- Conditions
- Colorectal Cancer
- Keywords
- Anesthesia, Propofol, Sevoflurane, Lidocaine, Cell Culture
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Prof. Dr. I. Chiricuta Institute of Oncology
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Nov 2019 (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.
Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Biological: Blood extraction, Drug: SevofluranePatients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent |
| Total intravenous anesthesia | Experimental | Biological: Blood extraction, Drug: PropofolPatients will receive a general anesthesia with Propofol as anesthetic agent |
| Total intravenous anesthesia and Lidocaine | Experimental | Drug: Lidocaine 1% Injectable Solution, Biological: Blood extractionPatients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol |
| Placebo | No intervention | –10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 80 years old patients admitted for elective colorectal surgery
Key exclusion criteria (10 listed)
- Pre-existing chronic pain
- Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids
- Contraindications to any of the medications in the study
- Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)
- Hepatic (ALT and / or AST> 2 normal wave) or renal (serum creatinine> 2 mg / dl)
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 |
|---|---|---|
| Lidocaine 1% Injectable SolutionAlso: Antiarrythmic drugLidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm * Induction: 1.5 mg / kg i.v. bolus before induction (at the vein catch). * Maintaining anesthesia: continuous infusion with Lidocaine 2 mg / kg / h, up to a maximum of 200 mg / h during maintenance (after IOT until waking) * Infusion with 1% Lidocaine will be reduced to 1.0- 1.5 mg / kg / hour, max 100 mg / hour, for the first 48 hours postop | Drug | Total intravenous anesthesia and Lidocaine |
| Blood extractionAlso: Biologic Human BloodThe patients will donate after consent 10 ml of blood prior and after surgery for further study | Biological | Sevoflurane, Total intravenous anesthesia, Total intravenous anesthesia and Lidocaine |
| SevofluraneAlso: Volatile Anesthetic DrugPatients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent | Drug | Sevoflurane |
| PropofolAlso: Intravenous Anesthetic DrugPatients will receive a general anesthesia with Propofol as anesthetic agent | Drug | Total intravenous anesthesia |
Primary outcome
Evaluation of the antiproliferative and apoptotic effects of anesthetic agents
Time frame: up to 4 years
The investigators aim to correlate the anticancer effects of two anesthetic techniques with tumor markers (p53;p38) and cell proteins involved in proliferation or apoptosis (IGFR;Bcl-2;Bcl-6). The investigators will report if the anesthetic agent used in cancer surgery influences the serologic values of these markers.
Evaluation of patients serum on cell culture
Time frame: up to 1 week
The investigators will investigate the serum of the patients who received different types of anesthesia (elective colorectal cancer surgery) by incubating it with colon cell lines (HCT116). The investigators will concentrate on cell proliferation assay. The investigators aim to discover how the growth of HCT116 will be influenced by patients' serum in terms of rate of proliferation. The measurements which will be used are Inhibitory Concentration (IC50) measured at 0 , 24 and 48 hours after incubation. The concentrations will be measured in mcg/ml.
2 secondary outcomes
Lidocaine concentration
Time frame: up to 4 years
Survival Comparison
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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. This study is not recruiting at the moment.
Ionescu Daniela, MD PHD DEEA study director
UMF Iuliu Hatieganu Cluj-Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine 1% Injectable Solution, Blood extraction and Sevoflurane in people with Colorectal Cancer, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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 Romania. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandru Alexa, MD (+40752691911, alexandru_reziati@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the antiproliferative and apoptotic effects of anesthetic agents (time frame: up to 4 years). 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 10 Feb 2021.