Lidocaine Infusion in Pancreatic Cancer

November 30, 2023 updated by: Effrossyni Votta-Velis, University of Illinois at Chicago

Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects

This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer.

A prospective randomized controlled double blinded trial design will be used for the proposed study.

Study Overview

Detailed Description

The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is expected that by downregulating the pathways by lidocaine might affect the enzymatic activity in those CTCs as well as the number of CTCs in the circulation.

A prospective randomized controlled double blinded trial design will be used for the proposed study.

Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexandra Barabanova, MS
  • Phone Number: (312)996-4020
  • Email: barabano@uic.edu

Study Contact Backup

  • Name: Gina E. Votta-Velis, MD PhD
  • Phone Number: (312)996-4020
  • Email: barabano@uic.edu

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illnois at Chicago
        • Contact:
          • Gina E Votta-Velis, MD PhD
          • Phone Number: 312-996-4020
          • Email: ginavot@uic.edu
        • Principal Investigator:
          • E. Gina Votta-Velis, MD PhD
        • Sub-Investigator:
          • Ajay Rana, PhD
        • Sub-Investigator:
          • Pier C. Giulianotti, MD
        • Sub-Investigator:
          • Alain A. Borgeat, MD
        • Sub-Investigator:
          • Sandeep Kumar, PhD
        • Sub-Investigator:
          • Antonio Gangemi, MD
        • Sub-Investigator:
          • Valentina Valle, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is considered resectable as well as other types of pancreatic cancer (malignant endocrine and exocrine tumors)
  2. Has measurable disease, defined as at least 1 tumor that fulfills the criteria
  3. Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease
  4. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC)
  5. Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.

Exclusion Criteria:

  1. Has American Society of Anesthesiologists (ASA) physical status > 3
  2. Has hypersensitivity or allergy to amide-linked local anesthetics
  3. Has a second or third degree heart block
  4. Has severe sinoatrial block
  5. Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide
  6. Has been treated with amiodarone in the past
  7. Has Adams-Stoke syndrome
  8. Has Wolff-Parkinson-White syndrome
  9. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment
  10. Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine Hydrochloride
The IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Names:
  • Xylocaine
Placebo Comparator: Saline Solution for Injection
The group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr)
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Names:
  • Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen outcome measure.
Time Frame: Outcomes will be evaluated perioperatively
Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.
Outcomes will be evaluated perioperatively
Specimen outcome measure.
Time Frame: Outcomes will be evaluated perioperatively
Cytokine Levels in Serum (pg/ml)
Outcomes will be evaluated perioperatively
Specimen outcome measure.
Time Frame: Outcomes will be evaluated perioperatively
Chemokine levels in serum (pg/ml)
Outcomes will be evaluated perioperatively
Upregulation or Downregulation of Gene Expression.
Time Frame: Outcomes will be evaluated perioperatively
Upregulation or downregulation of gene expression will be measured with the Real Time (RT) square Profiler Polimerase Chain Reaction (PCR )Array Analysis, and Real Time PCR
Outcomes will be evaluated perioperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen outcome measure
Time Frame: Perioperatively
CTCs Enumeration
Perioperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gina E. Votta-Velis, MD PhD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Estimated)

November 8, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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