RECRUITING

Impact of Daily Oral Cannabis Doses in Patients With Cancer

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months. There is a 3/4 (or 75%) chance that a participant will receive an active cannabis dose in the study. There is a 1/4 (or 25% chance) that a participant will receive a placebo dose (meaning a blank dose/no cannabis/no active drug). The goals of this study are to determine 1) the safety and tolerability of cannabis in individuals with cancer and 2) if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting, appetite, pain, sleep, and quality of life.

Official Title

A Phase I Study of the Effects of Cannabis on Cancer Burden: Placebo-Controlled, Double-Blind, Randomized Trial

Quick Facts

Study Start:2025-06-17

Study Completion:2030-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06601218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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, \&lt;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

Inclusion Criteria

Exclusion 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)

* 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, \&lt;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

Contacts and Locations

Study Contact

Grayson Fuller, MPH

CONTACT

859-257-4581

grayson.fuller@uky.edu

Principal Investigator

Shanna Babalonis, PhD

PRINCIPAL_INVESTIGATOR

University of Kentucky College of Medicine

Zin Myint, MD

PRINCIPAL_INVESTIGATOR

University of Kentucky College of Medicine

Study Locations (Sites)

University of Kentucky

Lexington, Kentucky, 40508

United States

Collaborators and Investigators

Sponsor: Shanna Babalonis, PhD

Shanna Babalonis, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky College of Medicine
Zin Myint, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17

Study Completion Date2030-12-01

Study Record Updates

Study Start Date2025-06-17

Study Completion Date2030-12-01

Terms related to this study

Additional Relevant MeSH Terms

Cancer
Cancers, Pain