NCT05250791

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

January 28, 2022

Last Update Submit

June 8, 2023

Conditions

Colorectal CancerQuality of LifeRecurrent Cancer

Keywords

PerioperativeIntravenous lidocainecancer recurrencecolorectal cancerquality of life

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (10)

  • Disease-free survival

    12-months post randomisation

  • Completion of EQ-5D-5L

    Baseline

  • Completion of EQ-5D-5L

    6 months post randomisation

  • Completion of EQ-5D-5L

    12-months post randomisation

  • Completion of the cancer-specific quality of life questionnaires

    Baseline

  • +5 more secondary outcomes

Other Outcomes (5)

  • Quantity of circulating free DNA

    Day 3 hospital stay

  • DNA whole-genome sequencing

    Day 3 hospital stay

  • Quantity of circulating tumour cells

    Day 3 hospital stay

  • +2 more other outcomes

Study Arms (2)

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.

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.

Drug: 0.9% sterile Sodium Chloride solution for injection

Interventions

Lidocaine hydrochloride 2% for injectionDRUG

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.

Also known as: Xylocaine
lidocaine
0.9% sterile Sodium Chloride solution for injectionDRUG

Administered as lidocaine

Also known as: Saline
0.9% sterile Sodium Chloride solution for injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37387798DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsRecurrence

Interventions

LidocaineInjectionsSodium Chloride

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDrug Administration RoutesDrug TherapyTherapeuticsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • West Raha, MBChB

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

West Raha, MBChB

CONTACT

07496833117flicor.trial@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 22, 2022

Study Start

February 2, 2023

Primary Completion

September 15, 2024

Study Completion

September 15, 2024

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)