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New treatment option for Opioid-Refractory Chronic Cancer-Related Pain
Official title The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.
ClinicalTrials.gov ID: NCT07408193
What this study is testing
What is Lidocaine and Ketamine Infusion?
Lidocaine and Ketamine Infusion is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for opioid-refractory chronic cancer-related pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Elevated intracranial or intraocular pressure
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Attica, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Attica, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.