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Lidocaine Infusion in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT04048278
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Effrossyni Votta-Velis, University of Illinois at Chicago

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Lidocaine Hydrochloride Drug: Saline Solution for Injection Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective randomized placebo-controlled double blinded trial design will be used for the proposed study.
Masking: Double (Participant, Care Provider)
Masking Description: Both patients and the physicians performing the cases will be unaware of who receives lidocaine or placebo.
Primary Purpose: Treatment
Official Title: Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : November 8, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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
Drug: Lidocaine Hydrochloride
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Name: 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)
Drug: Saline Solution for Injection
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Name: Sodium Chloride




Primary Outcome Measures :
  1. 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.

  2. Specimen outcome measure. [ Time Frame: Outcomes will be evaluated perioperatively ]
    Cytokine Levels in Serum (pg/ml)

  3. Specimen outcome measure. [ Time Frame: Outcomes will be evaluated perioperatively ]
    Chemokine levels in serum (pg/ml)

  4. 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


Secondary Outcome Measures :
  1. Specimen outcome measure [ Time Frame: Perioperatively ]
    CTCs Enumeration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048278


Contacts
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Contact: Alexandra Barabanova, MS (312)996-4020 barabano@uic.edu
Contact: Gina E. Votta-Velis, MD PhD (312)996-4020 barabano@uic.edu

Locations
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United States, Illinois
University of Illnois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Gina E Votta-Velis, MD PhD    312-996-4020    ginavot@uic.edu   
Contact: Alexandra Barabanova, MS    (312)355-5733    barabano@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         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Gina E. Votta-Velis, MD PhD Associate Professor
  Study Documents (Full-Text)

Documents provided by Effrossyni Votta-Velis, University of Illinois at Chicago:
Informed Consent Form  [PDF] June 10, 2018


Publications:
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Responsible Party: Effrossyni Votta-Velis, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04048278     History of Changes
Other Study ID Numbers: 2017-1365
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Effrossyni Votta-Velis, University of Illinois at Chicago:
Pancreas
Pancreatic Cancer
Lidocaine
Enzymatic Activity
Cytokines
Chemokines
Gene Expression
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action