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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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; 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.

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

Conditions
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Colorectal Cancer, Quality of Life, Recurrent Cancer

Intervention / Treatment
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* Drug: Lidocaine hydrochloride 2% for injection
* Drug: 0.9% sterile Sodium Chloride solution for injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine<br>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<br>* 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.<br>* Other names: Xylocaine;|
| Placebo Comparator: 0.9% sterile Sodium Chloride solution for injection<br>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<br>* Administered as lidocaine<br>* Other names: Saline;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous lidocaine, cancer recurrence, colorectal cancer, quality of life, Perioperative