NCT07432399 Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
| NCT ID | NCT07432399 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-09-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.
Eligibility Criteria
Inclusion Criteria: * Adult patients aged 18 years or older * Histologically confirmed colon cancer * Scheduled for elective surgical resection of colon cancer * Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol * Ability to understand the study procedures and provide written informed consent Exclusion Criteria: * Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients * Severe hepatic impairment * Severe renal impairment * Severe cardiac conduction disorders or clinically significant arrhythmias * Pregnancy or breastfeeding * Severe uncontrolled comorbidities that could interfere with study participation * Participation in another interventional clinical trial that could influence study outcomes * Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07432399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07432399 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07432399 currently recruiting?
Yes, NCT07432399 is actively recruiting participants. Contact the research team at NBesic@onko-i.si for enrollment information.
Where is the NCT07432399 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07432399 clinical trial?
NCT07432399 is sponsored by Institute of Oncology Ljubljana. The trial plans to enroll 100 participants.
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