Colorectal cancer patient undergoing surgery for cancer resection Cancer
Conditions
Interventions
The feasibility trial will be a double-blinded, randomised, controlled trial, comparing intravenous lidocaine administration versus placebo. An intravenous bolus of 2% lidocaine or placebo will be adm
Sponsors
Chelsea and Westminster Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above, undergoing laparoscopic surgery with stage 2 or 3 colon cancer 2. Ability and willingness to consent
Exclusion criteria
Exclusion criteria: 1. Stage 1 and stage 4 colon or rectal cancer 2. Palliative surgery with no curative intent 3. Extensive comorbidities, i.e. American Society of Anesthesiologists (ASA) Score IV 4. Patients with known allergy to lidocaine 5. Patients who are pregnant or breastfeeding 6. Patients who are likely to have adverse effects from the accumulation of intravenous lidocaine: 6.1. Known liver disease with liver function outside the normal laboratory range 6.2. Epilepsy 6.3. Cardiac conduction abnormalities based on history and confirmed by electrocardiogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes measured at baseline, hospital discharge, 6- and 12-months follow up post-randomisation: 1. The number of eligible patients and the actual number recruited for colon and rectal cancer with stage 2 or 3, taken from screening and recruitment logs 2. Trial retention measures by the number of participants who consent to participate who remain in the study until the end of follow up at 12 months 3. The feasibility, acceptability and return rates of data collection instruments, including those for the future economic evaluation alongside the definitive trial, measured using: 3.1. The completeness of responses to the health-related quality of life questionnaire, EQ- 5D-5L, collected at baseline, 6- and 12-months follow-up visit, which would be the outcome measure used in an economic evaluation as part of the definitive trial 3.2. The completeness of resource use data collected from an NHS and personal social services perspective using inpatient resource use data collected during the hospital stay from medical notes. A healthcare resource use form will be piloted for the definitive trial. This will be a bespoke patient questionnaire on primary and secondary healthcare and social care resource use following discharge at 6- and 12-months telephone follow up 4. Participants and clinical staff's experiences of the research process will be assessed at the end of the study with a short (10-question) close-ended questionnaire with optional free text relating to informed consent procedures, the information given, the recruitment process and any suggestions for improvement 5. Patients who refuse consent will be asked for their reasons at the point of recruitment only. Clinicians will be asked their reasons for not recruiting patients. Responses will be recorded on the screening log. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and patient-reported outcomes: 1. Disease-free survival, including cancer recurrence and death from any cause, will be captured from hospital medical records, health care resource use form and GP records at 12 months post-randomisation. Cancer recurrence will be assessed from routine cancer surveillance, including CT scan, colonoscopy, serum carcinoembryonic antigen tests, and histopathology reports. The cause of death will be looked at from the hospital and GP records. 2. Feasibility and completion of the outcome measure cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire at baseline, 6- and 12-months phone follow-up 3. Return to theatre, routine blood results, complications, blood transfusion and total hospital stay including readmission up to 12 months will be recorded from medical notes and healthcare resource use form Exploratory outcomes All measured at baseline, during surgery, at 24 hours (following completion of treatment) and on day 3: 1. The quantity of circulating free DNA in patients’ blood measured using circulating nucleic acid kit (Qiagen) and quantitative polymerase chain reaction assays and DNA next-generation sequencing panel for whole-genome sequencing on samples. 2. The circulating tumour cells quantity and functional characteristics between the two treatment groups will be measured using the cellular fraction of peripheral blood mononuclear cells through a sorter for non-immune cells. Cells will be cultured in vitro; functional characterisation study with flow method. 3. Pro-inflammatory cytokine levels measured using an enzyme-linked immunosorbent assay | — |
Countries
England, United Kingdom
Outcome results
None listed