Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome

Colorectal Cancer Clinical Trial

— FLICOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250791
• Other study ID #: 21CX7298
• Secondary ID: 2021-006185-20NI
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: June 2023
• Source: Imperial College London
• Contact: West Raha, MBChB
• Phone: 07496833117
• Email: flicor.trial[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Quality of Life
• Recurrence
• Recurrent Cancer

Intervention

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.
• 0.9% sterile Sodium Chloride solution for injection
Administered as lidocaine

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantity of circulating free DNA	Change from baseline quantity of circulating free DNA at treatment completion	Day 3 hospital stay
Other	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
Other	Quantity of circulating tumour cells	Change from baseline circulating tumour cells quantity at treatment completion	Day 3 hospital stay
Other	Circulating tumour cells functional characteristics	Comparison between lidocaine and placebo treatment group	Day 3 hospital stay
Other	Pro-inflammatory cytokine levels	Change from baseline pro-inflammatory cytokine levels at treatment completion	Day 3 hospital stay
Primary	Feasibility of recruitment	The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3.	Baseline
Primary	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
Primary	The completion of data collection instruments	on eCRF	6 months post randomisation
Primary	The completion of data collection instruments	on eCRF	12 months post randomisation
Primary	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
Primary	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
Primary	Patients' reasons to refuse consent.	Patients who refuse consent will be asked for their reasons at the point of recruitment only	Baseline
Primary	Clinicians' reasons for not recruiting patients.	Clinicians will be asked their reasons for not recruiting patients	Screening
Secondary	Disease-free survival	Cancer recurrence and death from any cause	12-months post randomisation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total hospital stays including readmission	Recorded from medical notes and healthcare resource use form.	12-months post randomisation