NCT07408193 The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.
| NCT ID | NCT07408193 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Opioid-Refractory Chronic Cancer-Related Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-08 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-03-01 with a primary completion date of 2027-08.
⚠ 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 is a randomized, double-blinded, placebo-controlled, cross-over trial examining the effect of a series of two weekly intravenous infusions of lidocaine 4 mg/kg and ketamine 0.2 mg/kg in patients with moderate to severe opioid-refractory chronic cancer-related pain. The aim of this study is to investigate whether the lidocaine - ketamine (LK) regimen provides better analgesia that an active placebo of midazolam 0.02 mg/kg, in this population.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or more * Capacity to provide informed consent, ability to complete study assessments and comply with the study procedures * Meets the IASP definition for chronic cancer-related pain * Moderate or severe pain, defined as average pain of 4 or greater on an 11-point (0-10) NRS in the past 24h * Adequate trial of opioid medication, defined as a dose of at least 60 mg/day oral morphine equivalent or maximum tolerated dose, in the past 24h * For patients with neuropathic component to pain: adequate trial of at least one adjuvant analgesic, defined as a daily dose of at least Amitriptyline 37.5mg, Duloxetine 30mg, Gabapentin 900mg, Pregabalin 150mg, Venlafaxine 60mg or equivalent (26), or maximum tolerated dose in the past 24h Exclusion Criteria: * Previous adverse reaction to ketamine, lidocaine or other amide-type local anesthetics, midazolam * Severe liver disease (Child Class B or C) * SGPT or SGOT \>5 times the upper limit of normal * End stage kidney disease * Serious cardiac comorbidity (e.g. unstable angina, poorly controlled hypertension or tachycardia, high-risk coronary vascular disease, symptomatic heart failure with NYHA class III-IV, history of heart block, Wolf-Parkinson-White syndrome, Adams-Stokes syndrome) * Elevated intracranial or intraocular pressure * Pheochromocytoma or poorly controlled hyperthyroidism * History of psychosis, schizophrenia or substance abuse * Pregnant or breastfeeding * Porphyria * Life expectancy shorter than the duration of the study
Contact & Investigator
Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
✉ kkalimeris@med.uoa.gr📞 +302105831997
Konstantinos Kalimeris, Assoc Prof of Anesthesiology
STUDY CHAIR
National and Kapodistrian University of Athens
Frequently Asked Questions
Who can join the NCT07408193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid-Refractory Chronic Cancer-Related Pain. 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 NCT07408193 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07408193 currently recruiting?
Yes, NCT07408193 is actively recruiting participants. Contact the research team at kkalimeris@med.uoa.gr for enrollment information.
Where is the NCT07408193 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07408193 clinical trial?
NCT07408193 is sponsored by National and Kapodistrian University of Athens. The principal investigator is Konstantinos Kalimeris, Assoc Prof of Anesthesiology at National and Kapodistrian University of Athens. The trial plans to enroll 24 participants.
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