Oral Cannabis for Cancer

Overseen By Grayson Fuller, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Shanna Babalonis, PhD

Must not be taking: Cannabis, THC, CBD, Checkpoint inhibitors

Disqualifiers: Cardiac conditions, HPV-related cancer, Psychiatric illness, others

Compensation: Varies

Number of Visits: 2

Duration: 4 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of oral cannabis on people with cancer. It aims to determine the safety of cannabis and its potential benefits for cancer-related issues such as nausea, pain, and sleep problems. Participants will receive either a real dose of cannabis or a placebo (a fake dose with no cannabis) for about four months. Those with cancer who are not currently using cannabis products and have controlled symptoms may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using cannabis, THC-containing medications, or certain investigational drugs. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that many adults with cancer prefer taking a cannabis treatment with THC and CBD by mouth instead of a placebo, indicating that most people tolerate the treatment well. However, the FDA has not approved cannabis for treating cancer or any other medical condition. Although cannabis use is increasing, there is not yet enough solid evidence to confirm its effectiveness in treating cancer. The treatment remains under study, and researchers are working to understand its safety for people. Joining this trial will help gather important information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about oral cannabis for cancer because it offers a natural and potentially less harmful alternative to traditional treatments like chemotherapy and radiation. Unlike other options, this treatment uses active ingredients THC and CBD, which may help manage pain and improve quality of life without the harsh side effects. Additionally, the study explores different dosing strategies, including low and high doses, as well as combinations of THC and CBD, to find the most effective approach. This personalized approach could lead to more tailored and effective cancer care.

What evidence suggests that oral cannabis might be an effective treatment for cancer-related side effects?

Research has shown that cannabis can help people with cancer by reducing symptoms like nausea, vomiting, and pain. Approximately 70% to 90% of cancer patients using cannabis report feeling better. Some studies suggest that cannabis might enhance the effectiveness of chemotherapy and lessen its side effects. However, cannabis does not treat or cure cancer itself. In this trial, participants may receive different formulations of cannabis, including a combination of THC and CBD, which has shown promise in improving the quality of life for cancer patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Zin W. Myint

Principal Investigator

University of Kentucky College of Medicine

Shanna Babalonis, PhD

Principal Investigator

University of Kentucky College of Medicine

Are You a Good Fit for This Trial?

This trial is for cancer patients experiencing pain. Participants must be willing to take a daily oral dose of cannabis or placebo for about 4 months. They have a higher chance of receiving active cannabis than a placebo.

Inclusion Criteria

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 for the duration of enrollment

My cancer is advanced or has spread, confirmed by tests.

Exclusion Criteria

Current use of investigational agents, <3 months after the use of investigational agents

Providing a sample testing positive for alcohol or non-medical use of other drugs during screening

History of hypersensitivity to cannabis or cannabinoids

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 visits (in-person)

Baseline

Baseline data collection with no drug administered

2 weeks

Daily app-based questionnaires

Treatment

Participants receive daily oral cannabis or placebo doses, including titration and tapering

4 months

Weekly in-home visits, daily video calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Weekly app-based questionnaires, final in-person visit

What Are the Treatments Tested in This Trial?

Interventions

• Oral Cannabis

Trial Overview The study tests the safety and effectiveness of different doses of oral cannabis (low THC, THC/CBD mix, high THC) compared to a placebo in managing cancer-related symptoms over approximately 4 months.

How Is the Trial Designed?

Group I: Arm 2: Active Cannabis Low Active Control 1 Intervention

This arm will administer an active low dose of cannabis

Group II: Arm 4: Active Cannabis (THC+CBD) Active Control 1 Intervention

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

Group III: Arm 3: Active Cannabis High Active Control 1 Intervention

This arm will administer an active high dose of cannabis

Group IV: Arm 1: Placebo Cannabis Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Shanna Babalonis, PhD

Lead Sponsor

Trials

5

Recruited

140+

Published Research Related to This Trial

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

Cannabinoids, particularly CBD and Δ9-THC, have shown potential in preclinical studies for treating various cancers, including leukemia and glioblastoma, by blocking tumor cell growth and inducing apoptosis.

Cannabinoid-based products are approved for medical use in cancer patients and have a favorable safety profile, although psychoactive effects and poor bioavailability can limit their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis and its constituents for cancer: History, biogenesis, chemistry and pharmacological activities. Lal, S., Shekher, A., Puneet, ., et al.[2021]

A study involving 63 cancer outpatients treated with oral anticancer agents revealed that 74.6% reported at least one high-level symptom, highlighting the prevalence of adverse events in this population.

The most commonly reported symptoms included fatigue, psychological disorders, and general pain, indicating that patient-reported outcomes (PROs) are effective for identifying significant side effects and can be integrated into routine oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program. Collomb, B., Dubromel, A., Caffin, AG., et al.[2022]

Cannabis has potential benefits for cancer patients, particularly in managing symptoms like nausea, pain, and appetite loss, and may be the only effective treatment for some individuals.

Emerging evidence suggests that cannabinoids may have direct anticancer effects through mechanisms like promoting cell death and inhibiting tumor growth, although more human studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating cannabis into clinical cancer care. Abrams, DI.[2018]

A study analyzing 202 adverse events (AEs) reported by patients on health forums found that musculoskeletal disorders were reported more frequently than in the French pharmacovigilance database (FPVD), suggesting patients may experience and discuss these issues more openly online.

In contrast, skin disorders were reported less frequently on patient websites compared to the FPVD, and overall, the AEs shared by patients were less serious than those recorded in the FPVD, indicating a potential difference in the severity of AEs perceived by patients versus those documented in formal reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undesirable effects related to oral antineoplastic drugs: comparison between patients' internet narratives and a national pharmacovigilance database. Pages, A., Bondon-Guitton, E., Montastruc, JL., et al.[2021]

A follow-up program involving pharmacists for outpatients treated with oral antineoplastic agents (OAA) showed a reduction in severe adverse events (AEs) and major drug interactions compared to patients who were not monitored, indicating improved safety in the intervention group.

The study included 249 patients over a 6-month period, revealing that while AEs were still common, the intervention group experienced fewer severe AEs and had better monitoring of drug interactions, particularly with medications like erlotinib and gefitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents. Escudero-Vilaplana, V., Ribed, A., Romero-Jimenez, RM., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352579/

The Efficacy of Cannabis in Oncology Patient Care and Its Anti ... Recent studies have shown that approximately 60–70% of cancer patients incorporate cannabis products into their ongoing therapy to alleviate ...

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1490621/full

Meta-analysis of medical cannabis outcomes and ... Patient-reported outcome measures indicate that 70%–90% of patients who used cannabis to directly treat cancer symptoms reported improvements, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0163725825000634

Effect of cannabinoids on the efficacy and side ... The data available to date raise the prospect that cannabinoids may increase the efficacy of chemotherapeutic agents while reducing their side effects.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01836

Oral Cannabis Extract for Secondary Prevention of ... Our data support the claim that oral THC:CBD is an effective and safe option for the prevention of refractory CINV. Availability, access, ...

5. cancer.org cancer.org/cancer/supportive-care/integrative-medicine/cannabis/benefits-of-cannabis.html

Possible Benefits of Cannabis for People With Cancer No, cannabis does not treat or cure cancer. Studies have not shown that cannabis can stop or slow the growth of cancer cells. Experts at the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11655613/

Adverse events associated with the use of cannabis-based ... The prevalence of CBP use in this population is estimated to be 20–48%, with increased use reported in the last 10 years [2–11].

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.02596

Cannabis and Cannabinoids in Adults With Cancer Eighty-three percent of adults with cancer preferred the oral THC:CBD regimen over placebo. These data support the use of oral THC:CBD cannabis ...

8. cancer.gov cancer.gov/about-cancer/treatment/cam/hp/cannabis-pdq

Cannabis and Cannabinoids (PDQ®) - NCI The U.S. Food and Drug Administration has not approved Cannabis as a treatment for cancer or any other medical condition.

9. news.cancerresearchuk.org news.cancerresearchuk.org/2022/05/13/cannabis-cannabinoids-and-cancer-the-evidence-so-far/

Cannabis, cannabinoids and cancer – the evidence so far Right now there isn't enough reliable evidence to prove that any form of cannabis can effectively treat cancer in patients.