Impact of Daily Oral Cannabis Doses in Patients With Cancer

NCT06601218 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 87078
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Cancers, Pain

Outcome Measures

Primary Outcomes (1)

• Percent of participants that withdraw from the study or are removed due to adverse events

  The percent of patients who elect to withdrawal from the study or removed by physician/investigators due AEs or safety concerns in each group will be measured and compared to the placebo group.

  5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)

Secondary Outcomes (4)

• Change in Heart Rate

  During each daily dose (daily for 4 months of daily dosing)

• Change in O2 saturation

  During each daily dose (daily for 4 months of daily dosing)

• Study withdraw rate

  5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)

• Cancer Burden Assessment

  5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)

Study Arms (4)

Arm 1: Placebo Cannabis

PLACEBO COMPARATOR

This arm will administer a placebo dose of oral cannabis (no active drug)

Drug: Placebo Comparator

Arm 2: Active Cannabis Low

ACTIVE COMPARATOR

This arm will administer an active low dose of cannabis

Drug: Oral cannabis low THC

Arm 3: Active Cannabis High

ACTIVE COMPARATOR

This arm will administer an active high dose of cannabis

Drug: Oral cannabis high THC

Arm 4: Active Cannabis (THC+CBD)

ACTIVE COMPARATOR

This arm will administer an active dose of cannabis (THC+CBD)

Drug: Oral cannabis THC/CBD

Interventions

Oral cannabis low THC DRUG

4 months daily dosing with oral cannabis low THC

Also known as: THC

Arm 2: Active Cannabis Low

Placebo Comparator DRUG

4 months of daily dosing with oral placebo

Also known as: Placebo

Arm 1: Placebo Cannabis

Oral cannabis high THC DRUG

4 months of daily dosing with oral cannabis with high THC

Also known as: THC

Arm 3: Active Cannabis High

Oral cannabis THC/CBD DRUG

4 months of daily dosing with oral cannabis with THC and CBD

Also known as: THC/CBD

Arm 4: Active Cannabis (THC+CBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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, \<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)

Sponsors & Collaborators

• Shanna Babalonis, PhD: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Shanna Babalonis, PhD

  University of Kentucky College of Medicine

  PRINCIPAL INVESTIGATOR

• Zin Myint, MD

  University of Kentucky College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grayson Fuller, MPH

CONTACT

859-257-4581; grayson.fuller@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, College of Medicine

Model Details: Randomization into 4 arms - each arm administers a dose of oral cannabis or placebo

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: June 17, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)