Lidocaine Infusion in Pancreatic Cancer

NCT04048278 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2017-1365
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• Specimen outcome measure.

  Cytokine Levels in Serum (pg/ml)

  Outcomes will be evaluated perioperatively

• Specimen outcome measure.

  Chemokine levels in serum (pg/ml)

  Outcomes will be evaluated perioperatively

• 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 Outcomes (1)

• Specimen outcome measure

  Perioperatively

Study Arms (2)

Lidocaine Hydrochloride

EXPERIMENTAL

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

Saline Solution for Injection

PLACEBO COMPARATOR

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

Interventions

Lidocaine Hydrochloride DRUG

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

Also known as: Xylocaine

Lidocaine Hydrochloride

Saline Solution for Injection DRUG

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

Also known as: Sodium Chloride

Saline Solution for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illnois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 14527919 BACKGROUND

• 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.

  PMID: 10744945 BACKGROUND

• 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.

  PMID: 30640648 BACKGROUND

• 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.

  PMID: 24218336 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Lidocaine; Saline Solution; Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gina E. Votta-Velis, MD PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Barabanova, MS

CONTACT

(312)996-4020; barabano@uic.edu

Gina E. Votta-Velis, MD PhD

CONTACT

(312)996-4020; barabano@uic.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both patients and the physicians performing the cases will be unaware of who receives lidocaine or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: August 7, 2019
• Study Start: November 8, 2018
• Primary Completion: November 8, 2025
• Study Completion: January 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)