Colorectal Cancer, Quality of Life, Recurrent Cancer
Conditions
Keywords
Perioperative, Intravenous lidocaine, cancer recurrence, colorectal cancer, quality of life
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.
Interventions
DRUGLidocaine 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.
DRUG0.9% sterile Sodium Chloride solution for injection
Administered as lidocaine
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical staff feedback of study experiences | 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. |
| The completion of data collection instruments | 6 months post randomisation | on eCRF |
| Participant's feedback of study experiences | 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. |
| Feasibility of recruitment | Baseline | The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3. |
| Trial retention | 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. |
| Clinicians' reasons for not recruiting patients. | Screening | Clinicians will be asked their reasons for not recruiting patients |
| Patients' reasons to refuse consent. | Baseline | Patients who refuse consent will be asked for their reasons at the point of recruitment only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of healthcare and social care resource use questionnaires | 6 months post randomisation | This will be a bespoke patient questionnaire on primary and secondary healthcare and social care resource use. |
| Disease-free survival | 12-months post randomisation | Cancer recurrence and death from any cause |
| Completion of EQ-5D-5L | Baseline | 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. |
| Completion of the cancer-specific quality of life questionnaires | Baseline | Feasibility and completion of the Cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire. |
| Total hospital stays including readmission | 12-months post randomisation | Recorded from medical notes and healthcare resource use form. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quantity of circulating free DNA | Day 3 hospital stay | Change from baseline quantity of circulating free DNA at treatment completion |
| Pro-inflammatory cytokine levels | Day 3 hospital stay | Change from baseline pro-inflammatory cytokine levels at treatment completion |
| Circulating tumour cells functional characteristics | Day 3 hospital stay | Comparison between lidocaine and placebo treatment group |
| Quantity of circulating tumour cells | Day 3 hospital stay | Change from baseline circulating tumour cells quantity at treatment completion |
| DNA whole-genome sequencing | Day 3 hospital stay | Quantitative genomic analysis of the blood cells to study the characteristics and investigate the technical feasibility of this for the future definitive trial. |
Countries
United Kingdom
Contacts
Primary ContactWest Raha, MBChB
Outcome results
None listed