Clinical trial NCT05250791: Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome
Official title: A Randomised Feasibility Study Evaluating the Effect of Perioperative Intravenous Lidocaine on Colorectal Cancer Outcome After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Quality of Life
Recurrent Cancer
Keywords: Perioperative
Intravenous lidocaine
cancer recurrence
colorectal cancer
quality of life
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline
measure: Trial retention
timeFrame: 12 months post randomisation
measure: The completion of data collection instruments
timeFrame: 6 months post randomisation
measure: The completion of data collection instruments
timeFrame: 12 months post randomisation
measure: Participant's feedback of study experiences
timeFrame: Day 3 hospital stay
measure: Clinical staff feedback of study experiences
timeFrame: Day 3 hospital stay
measure: Patients' reasons to refuse consent.
timeFrame: Baseline
measure: Clinicians' reasons for not recruiting patients.
timeFrame: Screening
Secondary outcomes:
measure: Disease-free survival
timeFrame: 12-months post randomisation
measure: Completion of EQ-5D-5L
timeFrame: Baseline
measure: Completion of EQ-5D-5L
timeFrame: 6 months post randomisation
measure: Completion of EQ-5D-5L
timeFrame: 12-months post randomisation
measure: Completion of the cancer-specific quality of life questionnaires
timeFrame: Baseline
measure: Completion of the cancer-specific quality of life questionnaires
timeFrame: 6 months post randomisation
measure: Completion of the cancer-specific quality of life questionnaires
timeFrame: 12-months post randomisation
measure: Completion of healthcare and social care resource use questionnaires
timeFrame: 6 months post randomisation
measure: Completion of healthcare and social care resource use questionnaires
timeFrame: 12-months post randomisation
measure: Total hospital stays including readmission
timeFrame: 12-months post randomisation
Other outcomes:
measure: Quantity of circulating free DNA
timeFrame: Day 3 hospital stay
measure: DNA whole-genome sequencing
timeFrame: Day 3 hospital stay
measure: Quantity of circulating tumour cells
timeFrame: Day 3 hospital stay
measure: Circulating tumour cells functional characteristics
timeFrame: Day 3 hospital stay
measure: Pro-inflammatory cytokine levels
timeFrame: Day 3 hospital stay
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: West Raha, MBChB
role: PRINCIPAL_INVESTIGATOR
References: