Lidocaine Infusion in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04048278
• Other study ID #: 2017-1365
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 8, 2018
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: University of Illinois at Chicago
• Contact: Alexandra Barabanova, MS
• Phone: (312)996-4020
• Email: barabano[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 1, 2025
• Est. primary completion date: November 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Lidocaine Hydrochloride
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
• Saline Solution for Injection
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Locations

Country	Name	City	State
United States	University of Illnois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specimen outcome measure.	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
Primary	Specimen outcome measure.	Cytokine Levels in Serum (pg/ml)	Outcomes will be evaluated perioperatively
Primary	Specimen outcome measure.	Chemokine levels in serum (pg/ml)	Outcomes will be evaluated perioperatively
Primary	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	Outcomes will be evaluated perioperatively
Secondary	Specimen outcome measure	CTCs Enumeration	Perioperatively