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Lidocaine Infusion in Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lidocaine Hydrochloride

Saline Solution for Injection

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreas, Pancreatic Cancer, Lidocaine, Enzymatic Activity, Cytokines, Chemokines, Gene Expression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
Has measurable disease, defined as at least 1 tumor that fulfills the criteria
Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease
Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC)
Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.

Exclusion Criteria:

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

Sites / Locations

University of Illnois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine Hydrochloride

Saline Solution for Injection

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Specimen outcome measure.

Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.

Specimen outcome measure.

Cytokine Levels in Serum (pg/ml)

Specimen outcome measure.

Chemokine levels in serum (pg/ml)

Upregulation or Downregulation of Gene Expression.

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

Specimen outcome measure

CTCs Enumeration

Full Information

NCT ID

NCT04048278

First Posted

June 18, 2019

Last Updated

April 8, 2022

Sponsor

University of Illinois at Chicago

1. Study Identification

Unique Protocol Identification Number

NCT04048278

Brief Title

Lidocaine Infusion in Pancreatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 8, 2018 (Actual)

Primary Completion Date

November 8, 2022 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Pancreas, Pancreatic Cancer, Lidocaine, Enzymatic Activity, Cytokines, Chemokines, Gene Expression

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare Provider

Masking Description

Both patients and the physicians performing the cases will be unaware of who receives lidocaine or placebo.

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine Hydrochloride

Arm Type

Experimental

Arm Description

Arm Title

Saline Solution for Injection

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lidocaine Hydrochloride

Other Intervention Name(s)

Xylocaine

Intervention Description

IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Intervention Type

Drug

Intervention Name(s)

Saline Solution for Injection

Other Intervention Name(s)

Sodium Chloride

Intervention Description

IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Primary Outcome Measure Information:

Title

Specimen outcome measure.

Description

Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.

Time Frame

Outcomes will be evaluated perioperatively

Title

Specimen outcome measure.

Description

Cytokine Levels in Serum (pg/ml)

Time Frame

Outcomes will be evaluated perioperatively

Title

Specimen outcome measure.

Description

Chemokine levels in serum (pg/ml)

Time Frame

Outcomes will be evaluated perioperatively

Title

Upregulation or Downregulation of Gene Expression.

Description

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

Time Frame

Outcomes will be evaluated perioperatively

Secondary Outcome Measure Information:

Title

Specimen outcome measure

Description

CTCs Enumeration

Time Frame

Perioperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Has measurable disease, defined as at least 1 tumor that fulfills the criteria Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC) Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy. Exclusion Criteria: Has American Society of Anesthesiologists (ASA) physical status > 3 Has hypersensitivity or allergy to amide-linked local anesthetics Has a second or third degree heart block Has severe sinoatrial block Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide Has been treated with amiodarone in the past Has Adams-Stoke syndrome Has Wolff-Parkinson-White syndrome Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Barabanova, MS

Phone

(312)996-4020

barabano@uic.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Gina E. Votta-Velis, MD PhD

Phone

(312)996-4020

barabano@uic.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gina E. Votta-Velis, MD PhD

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Illnois at Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gina E Votta-Velis, MD PhD

Phone

312-996-4020

ginavot@uic.edu

First Name & Middle Initial & Last Name & Degree

Alexandra Barabanova, MS

Phone

(312)355-5733

barabano@uic.edu

First Name & Middle Initial & Last Name & Degree

E. Gina Votta-Velis, MD PhD

First Name & Middle Initial & Last Name & Degree

Ajay Rana, PhD

First Name & Middle Initial & Last Name & Degree

Pier C. Giulianotti, MD

First Name & Middle Initial & Last Name & Degree

Alain A. Borgeat, MD

First Name & Middle Initial & Last Name & Degree

Sandeep Kumar, PhD

First Name & Middle Initial & Last Name & Degree

Antonio Gangemi, MD

First Name & Middle Initial & Last Name & Degree

Valentina Valle, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14527919

Citation

Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.

Results Reference

background

PubMed Identifier

10744945

Citation

Mokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195. doi: 10.1053/ejso.1999.0771. No abstract available.

Results Reference

background

PubMed Identifier

30640648

Citation

Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.

Results Reference

background

PubMed Identifier

24218336

Citation

Han L, Chen W, Zhao Q. Prognostic value of circulating tumor cells in patients with pancreatic cancer: a meta-analysis. Tumour Biol. 2014 Mar;35(3):2473-80. doi: 10.1007/s13277-013-1327-5. Epub 2013 Nov 12.

Results Reference

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Lidocaine Infusion in Pancreatic Cancer

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