Could cannabis ease Cancer's worst side effects?
NCT ID NCT06601218
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study tests whether daily oral cannabis can safely help manage symptoms like pain, nausea, poor appetite, and sleep problems in people with advanced solid tumors. Participants are randomly assigned to receive one of three cannabis formulations or a placebo for about four months. The main goal is to see if cannabis is well-tolerated and whether it improves quality of life during cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral cannabis with varying levels of THC and CBD
- What this could lead to
- If it works, this could point toward a safe way to use cannabis to manage common cancer-related symptoms like pain, nausea, and poor appetite.
- What could go wrong
- This is an early phase 1 trial focused on safety, not yet on effectiveness. The results may not show clear symptom relief, and side effects from cannabis could occur.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Example Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic solid tumors with any types. This applies to either newly diagnosed cancer or preexisting ones on treatment. * Patients with active cancers and currently under any line of treatment (please see notable exceptions in the exclusion criteria - patients taking checkpoint inhibitors and investigational agents will not be eligible - also exclusionary medications). * Patients have been taking their current anti-cancer therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation). * Age ≥18 years. * ECG and lab values demonstrating adequate organ and marrow function at baseline (pre-study). * Negative urine drug screen for all illicit drugs and THC, CBD prior to randomization * Ability to understand and the willingness to sign a written informed consent document * Individuals able to become pregnant will agree to practice an effective form of contraception (e.g., oral birth control pills, condoms, abstinence) for the duration of enrollment (note: urine pregnancy testing will occur monthly) Exclusion Criteria: * History of hypersensitivity to cannabis or cannabinoids * Current, regular use of cannabis/marijuana or THC-containing medications (dronabinol, nabilone) or cannabidiol (Epidiolex) or over-the-counter (OTC) CBD oil. * Concomitant use of checkpoint inhibitors (e.g., anti-PD1, PDL1, CTLA4) or other drugs for which an cannabinoid interaction may occur. * Current use of investigational agents, \<3 months after the use of investigational agents * Cardiac conditions contraindicated for cannabis use * Diagnosis of HPV-related cancer, as there is some evidence that cannabis is contraindicated * Allergy to any constituent/ingredient contained in the edible dose * Psychiatric illness/social situations that would limit compliance with study requirements (e.g., bipolar disorder, psychosis, severe depression/anxiety). * Pregnant or breastfeeding (note: participants will be tested for pregnancy (urine sample) once per month during enrollment) * Current moderate/severe drug or alcohol use disorder (including cannabis use disorder), positive urine drug screen for illicit drugs or cannabis, or positive alcohol (breathalyzer) during screening * History of seizure disorder, epilepsy (controlled or uncontrolled) * Current legal obligations (parole, probation, incarceration, urine drug screen requirements as part of parole/probation/previous incarceration) * Currently enrolled in substance use treatment * Self-reported cannabis and synthetic cannabinoid use in the past 30 days (medical or non-medical use is exclusionary) * Self-reported illicit drug use in past 60 days (ex: methamphetamine, heroin, illicit fentanyl) * Self-reported daily alcohol use * Providing a urine sample testing positive for cannabinoids (THC, CBD) or synthetic cannabinoids (K2, Spice-like compounds) * Providing a sample testing positive for alcohol (breathalyzer) or non-medical use of other drugs (methamphetamine, cocaine) during screening; testing positive during enrollment will lead to discontinuation of the participant's enrollment * No access to internet/data or devices needed to participate in daily video calls
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Kentucky
RECRUITINGLexington, Kentucky, 40508, United States
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