Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome (FLICOR)

A Randomised Feasibility Study Evaluating the Effect of Perioperative Intravenous Lidocaine on Colorectal Cancer Outcome After Surgery

This feasibility (small) study aims to see if it is possible to run a large study looking at the effect of lidocaine on large bowel cancer recurrence after surgery in the NHS hospitals.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Colorectal Cancer; Recurrent Cancer
• Intervention / Treatment: Drug: Lidocaine hydrochloride 2% for injection; Drug: 0.9% sterile Sodium Chloride solution for injection

Detailed Description

Strong preclinical evidence suggests that lidocaine, a type of local anaesthetic commonly used, could potentially reduce cancer recurrence if given during cancer surgery. This study will evaluate the feasibility of conducting a study comparing intravenous lidocaine infusion versus placebo administration for 24 hours from the start of general anaesthesia. The specific population will be any stage 2 or 3 colon or rectal cancer patient undergoing elective laparoscopic colorectal cancer surgery to look at postoperative cancer outcomes in two NHS settings. This study will explore the acceptability, facilitators and potential barriers of recruiting cancer patients, with possible anxieties of a new cancer diagnosis about to have major surgery along with other potential feasibility issues. It will also assess if follow-up and outcome data collection can be streamlined with usual care processes as much as possible and to guide the future definitive trial.

The project will:

1. Perform a feasibility study. This will be similar in design to the future bigger study and will see:

   • if there are any problems in giving lidocaine;
   • if patients and clinicians would be happy to take part in a study using a design where some patients get the drug and others get a non-active substance (known as placebo);
   • how many patients can we get from the different types and stages of bowel cancer;
   • if patients can be followed up successfully;
   • if we can collect all the data that we would need;
   • what measures might work well for the future study;
2. Look to see if blood tests can give some idea on how lidocaine might work in patients and if it can be confirmed in the bigger study.

The study will involve a small number of patients getting either lidocaine or placebo, and:

• filling in questionnaires to measure quality of life;
• follow up phone call at 6 and 12 months after surgery;
• having their records looked at to see if cancer comes back;
• both patients and clinicians to fill in a feedback questionnaire to see how they get on with the study processes;
• having extra blood tests before and after they finish the lidocaine/placebo infusion.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: West Raha, MBChB; Phone Number: 07496833117; Email: flicor.trial@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Jamie Murphy
  • London, United Kingdom
    • Recruiting
    • Chelsea and Westminster Hospital NHS Foundation Trust
    • Contact: Marcela Vizcaychipi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 and above, undergoing laparoscopic surgery with stage 2 or 3 colon cancer
• Age 18 and above, undergoing laparoscopic surgery with stage 2 or 3 rectal cancer
• Ability and willingness to consent

Exclusion Criteria:

• Stage 1 and stage 4 colon or rectal cancer
• Palliative surgery with no curative intent
• Extensive comorbidities, i.e. American Society of Anesthesiologists (ASA) Score IV
• Patients with known or suspected allergy to lidocaine
• Patients who are currently pregnant* or breastfeeding

• Patients who are likely to have adverse effects from the accumulation of intravenous lidocaine:

  • current liver disease with a liver function outside the normal laboratory range
  • current renal failure (eGFR <30)
  • epilepsy
  • cardiac conduction abnormalities based on history and confirmed by electrocardiogram

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lidocaine; An intravenous bolus of 2% lidocaine will be administered following the induction of anaesthesia at 1.5mg/kg ideal body weight over 20 minutes followed by intravenous infusion of 1.5 mg/kg/hour ideal body weight with a maximum rate of 120mg/hour for 24 hours.	Drug: Lidocaine hydrochloride 2% for injection; An intravenous bolus of 2% lidocaine will be administered following the induction of anaesthesia at 1.5mg/kg ideal body weight over 20 minutes followed by intravenous infusion of 1.5 mg/kg/hour ideal body weight with a maximum rate of 120mg/hour for 24 hours.; Other Names: Xylocaine
Placebo Comparator: 0.9% sterile Sodium Chloride solution for injection; An equivalent infusion rate (ml) of placebo will be administered following the induction of anaesthesia over 20 minutes followed by hourly equivalent intravenous infusion in ml/hr of placebo with a maximum rate of 6mls/hr (equivalent of 120mg/hour for lidocaine) for 24 hours.	Drug: 0.9% sterile Sodium Chloride solution for injection; Administered as lidocaine; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3.	Baseline
Trial retention	The number of participants who consent to participate who remain in the study until the end of follow up at 12 months.	12 months post randomisation
The completion of data collection instruments	on eCRF	6 months post randomisation
The completion of data collection instruments	on eCRF	12 months post randomisation
Participant's feedback of study experiences	10 questions close-ended questionnaire with optional free text relating to informed consent procedures, the information given, the recruitment process and any suggestions for improvement.	Day 3 hospital stay
Clinical staff feedback of study experiences	10 questions close-ended questionnaire with optional free text relating to informed consent procedures, the information given, the recruitment process and any suggestions for improvement.	Day 3 hospital stay
Patients' reasons to refuse consent.	Patients who refuse consent will be asked for their reasons at the point of recruitment only	Baseline
Clinicians' reasons for not recruiting patients.	Clinicians will be asked their reasons for not recruiting patients	Screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Cancer recurrence and death from any cause	12-months post randomisation
Completion of EQ-5D-5L	The completeness of responses to the health-related quality of life questionnaire, EQ- 5D-5L which would be the outcome measure used in an economic evaluation as part of the definitive trial.	Baseline
Completion of EQ-5D-5L	The completeness of responses to the health-related quality of life questionnaire, EQ- 5D-5L which would be the outcome measure used in an economic evaluation as part of the definitive trial.	6 months post randomisation
Completion of EQ-5D-5L	The completeness of responses to the health-related quality of life questionnaire, EQ- 5D-5L which would be the outcome measure used in an economic evaluation as part of the definitive trial.	12-months post randomisation
Completion of the cancer-specific quality of life questionnaires	Feasibility and completion of the Cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire.	Baseline
Completion of the cancer-specific quality of life questionnaires	Feasibility and completion of the Cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire.	6 months post randomisation
Completion of the cancer-specific quality of life questionnaires	Feasibility and completion of the Cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire.	12-months post randomisation
Completion of healthcare and social care resource use questionnaires	This will be a bespoke patient questionnaire on primary and secondary healthcare and social care resource use.	6 months post randomisation
Completion of healthcare and social care resource use questionnaires	This will be a bespoke patient questionnaire on primary and secondary healthcare and social care resource use.	12-months post randomisation
Total hospital stays including readmission	Recorded from medical notes and healthcare resource use form.	12-months post randomisation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of circulating free DNA	Change from baseline quantity of circulating free DNA at treatment completion	Day 3 hospital stay
DNA whole-genome sequencing	Quantitative genomic analysis of the blood cells to study the characteristics and investigate the technical feasibility of this for the future definitive trial.	Day 3 hospital stay
Quantity of circulating tumour cells	Change from baseline circulating tumour cells quantity at treatment completion	Day 3 hospital stay
Circulating tumour cells functional characteristics	Comparison between lidocaine and placebo treatment group	Day 3 hospital stay
Pro-inflammatory cytokine levels	Change from baseline pro-inflammatory cytokine levels at treatment completion	Day 3 hospital stay

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: West Raha, MBChB, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: colorectal cancer; quality of life; Perioperative; cancer recurrence; Intravenous lidocaine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 21CX7298; 2021-006185-20 (EudraCT Number); NIHR301741 (Other Grant/Funding Number: National Institute for Health Research); 1004491 (Registry Identifier: IRAS number)

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No