Colorectal CancerFLICORNCT05250791
Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome
A study testing Lidocaine hydrochloride 2% for injection and 0.9% sterile Sodium Chloride solution for injection in people with Colorectal Cancer and Quality of Life, run by Imperial College London at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Quality of Life, Recurrent Cancer
- What is being tested?
- Lidocaine hydrochloride 2% for injection and 0.9% sterile Sodium Chloride solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 Feb 2023to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Chelsea and Westminster Hospital NHS Foundation Trust
London
Marcela Vizcaychipi
- Recruiting
Imperial College Healthcare NHS Trust
London
Jamie Murphy
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Colorectal Cancer, Quality of Life, Recurrent Cancer
- Being tested
- Lidocaine hydrochloride 2% for injection, 0.9% sterile Sodium Chloride solution for injection
- Keywords
- Perioperative, Intravenous lidocaine, cancer recurrence, colorectal cancer, quality of life
- Medical subject headings
- Colorectal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine hydrochloride 2% for injectionDrug
Also called Xylocaine
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 injectionDrug
Also called Saline
Administered as lidocaine
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Active comparator | 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. Receives: Drug: Lidocaine hydrochloride 2% for injection |
| 0.9% sterile Sodium Chloride solution for injection | Placebo comparator | 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. Receives: Drug: 0.9% sterile Sodium Chloride solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3.
Measured: 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.
Measured: 12 months post randomisation
The completion of data collection instruments
on eCRF
Measured: 6 months post randomisation
The completion of data collection instruments
on eCRF
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Clinicians' reasons for not recruiting patients.
Clinicians will be asked their reasons for not recruiting patients
Measured: Screening
Secondary outcomes (10)
Disease-free survival
Cancer recurrence and death from any cause
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-months post randomisation
Total hospital stays including readmission
Recorded from medical notes and healthcare resource use form.
Measured: 12-months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start2 Feb 2023
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- West Raha, MBChB, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250791
- Sponsor's protocol ID
- 21CX7298
- Other IDs
- 2021-006185-20, NIHR301741, 1004491
- Acronym
- FLICOR
- Status last verified
- Jun 2023
- First submitted
- 28 Jan 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
West R, Soo CP, Murphy J, Vizcaychipi MP, Ma D. A protocol for a pilot study to assess the feasibility of a randomised clinical trial of perioperative intravenous lidocaine on colorectal cancer outcome after surgery (FLICOR trial). BJA Open. 2023 Jun;6:100138. doi: 10.1016/j.bjao.2023.100138.
PubMed 37387798
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Study Evaluating the Effect of Perioperative Intravenous Lidocaine on Colorectal Cancer Outcome After Surgery
- ClinicalTrials.gov ID
- NCT05250791
- Acronym / sponsor ID
- FLICOR / 21CX7298
- Conditions
- Colorectal Cancer, Quality of Life, Recurrent Cancer
- Keywords
- Perioperative, Intravenous lidocaine, cancer recurrence, colorectal cancer, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Active comparator | Drug: Lidocaine hydrochloride 2% for injectionAn 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 | Placebo comparator | Drug: 0.9% sterile Sodium Chloride solution for injectionAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine hydrochloride 2% for injectionAlso: XylocaineAn 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 |
| 0.9% sterile Sodium Chloride solution for injectionAlso: SalineAdministered as lidocaine | Drug | 0.9% sterile Sodium Chloride solution for injection |
Primary outcome
Feasibility of recruitment
Time frame: Baseline
The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3.
Trial retention
Time frame: 12 months post randomisation
The number of participants who consent to participate who remain in the study until the end of follow up at 12 months.
The completion of data collection instruments
Time frame: 6 months post randomisation
on eCRF
The completion of data collection instruments
Time frame: 12 months post randomisation
on eCRF
Participant's feedback of study experiences
Time frame: Day 3 hospital stay
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.
Clinical staff feedback of study experiences
Time frame: Day 3 hospital stay
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.
Patients' reasons to refuse consent.
Time frame: Baseline
Patients who refuse consent will be asked for their reasons at the point of recruitment only
Clinicians' reasons for not recruiting patients.
Time frame: Screening
Clinicians will be asked their reasons for not recruiting patients
10 secondary outcomes
Disease-free survival
Time frame: 12-months post randomisation
Completion of EQ-5D-5L
Time frame: Baseline
Completion of EQ-5D-5L
Time frame: 6 months post randomisation
Completion of EQ-5D-5L
Time frame: 12-months post randomisation
Completion of the cancer-specific quality of life questionnaires
Time frame: Baseline
Completion of the cancer-specific quality of life questionnaires
Time frame: 6 months post randomisation
Completion of the cancer-specific quality of life questionnaires
Time frame: 12-months post randomisation
Completion of healthcare and social care resource use questionnaires
Time frame: 6 months post randomisation
Completion of healthcare and social care resource use questionnaires
Time frame: 12-months post randomisation
Total hospital stays including readmission
Time frame: 12-months post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Derived from this study: PubMed 37387798West R, Soo CP, Murphy J, Vizcaychipi MP, Ma D. A protocol for a pilot study to assess the feasibility of a randomised clinical trial of perioperative intravenous lidocaine on colorectal cancer outcome after surgery (FLICOR trial). BJA Open. 2023 Jun;6:100138. doi: 10.1016/j.bjao.2023.100138.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
West Raha, MBChB principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine hydrochloride 2% for injection and 0.9% sterile Sodium Chloride solution for injection in people with Colorectal Cancer and Quality of Life, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact West Raha, MBChB (07496833117, flicor.trial@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.