Daily oral cannabis doses for people with cancer
A Phase I Study of the Effects of Cannabis on Cancer Burden: Placebo-Controlled, Double-Blind, Randomized Trial
This phase 1 test will give adults with cancer daily oral cannabis or placebo for about four months to see if it helps symptoms like pain, nausea, appetite, sleep, and quality of life.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06601218 on ClinicalTrials.gov |
What this trial studies
Participants are randomized in a 3:1 ratio to receive daily oral cannabis (5 mg THC, 15 mg THC, or 15 mg THC + 15 mg CBD) or placebo for approximately four months in this Phase 1 interventional protocol. The primary goal is to measure safety and tolerability by comparing withdrawal rates and adverse events across dose groups versus placebo, with acute monitoring of vitals and device-recorded heart rate and oxygen saturation after dosing. Secondary outcomes include determining a tolerated dose for future studies and measuring effects on cancer symptom burden using the FACT Symptom Index at baseline, during dosing, and follow-up. Eligible adults have histologically confirmed locally advanced or metastatic solid tumors on a stable anti-cancer regimen and must pass screening tests such as a negative urine drug screen and adequate labs; the study is conducted at the University of Kentucky in Lexington.
Who should consider this trial
Good fit: Adults (≥18) with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are on a stable anti-cancer therapy for at least one month, have adequate organ and marrow function, and a negative urine drug screen would be ideal candidates.
Not a fit: Patients receiving checkpoint inhibitors or other investigational anti-cancer agents, those with positive THC/CBD or illicit drug screens, pregnant individuals, or those with significant organ dysfunction are unlikely to be eligible or receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer a tolerable, oral option to reduce cancer- and treatment-related symptoms like pain, nausea, poor appetite, and poor sleep, improving quality of life.
How similar studies have performed: Some prior clinical and observational work and anecdotal reports suggest cannabinoids can help cancer-related symptoms, but rigorous randomized data in patients on active anti-cancer therapy remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Shanna Babalonis, PhD — University of Kentucky College of Medicine
- Study coordinator: Grayson Fuller, MPH
- Email: grayson.fuller@uky.edu
- Phone: 859-257-4581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.