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New combo infusion aims to tame Opioid-Resistant cancer pain

NCT ID NCT07408193

Symptom relief Sponsor: National and Kapodistrian University of Athens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This early-phase trial tests whether combining lidocaine and ketamine can reduce severe cancer-related pain that doesn't respond to opioids. Twenty-four adults will receive two weekly infusions of the drug combination or an active placebo in a blinded, crossover design. The goal is to see if this approach provides better pain relief than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cancer Pain neoplasm opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid-refractory chronic cancer-related pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School

    RECRUITING

    Athens, Attica, 12461, Greece