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

Trial Summary

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.

What data supports the effectiveness of the drug Oral Cannabis for cancer?

Research shows that cannabis, including its components like CBD and THC, can help manage cancer-related symptoms such as pain, nausea, and appetite loss. Some studies also suggest that cannabinoids might have direct anticancer effects, like blocking cancer cell growth and enhancing the effectiveness of other cancer treatments. ^{1 2 3 4 5}

Is oral cannabis generally safe for humans?

The safety of oral cannabis specifically for cancer treatment isn't directly addressed in the provided research, but studies on oral anticancer drugs show that patients often experience side effects like fatigue, psychological issues, and pain. Monitoring and reporting systems help manage these side effects to improve patient safety. ^{6 7 8 9 10}

How does the drug Oral Cannabis differ from other treatments for cancer?

Oral Cannabis is unique because it is taken by mouth and may help manage cancer symptoms like pain, nausea, and loss of appetite, which are common side effects of cancer and its treatments. Unlike some other treatments, it may also have a direct anticancer effect by promoting cancer cell death and preventing cancer spread, although more research is needed to confirm these effects. ^{2 4 5 11 12}

What is the purpose of this trial?

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.

Research Team

Zin W. Myint

Principal Investigator

University of Kentucky College of Medicine

Shanna Babalonis, PhD

Principal Investigator

University of Kentucky College of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Medical cannabis is effective for cancer-related pain: Quebec Cannabis Registry results. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Cannabis and Cannabinoids in Patients With Cancer. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cannabis and its constituents for cancer: History, biogenesis, chemistry and pharmacological activities. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A large Australian longitudinal cohort registry demonstrates sustained safety and efficacy of oral medicinal cannabis for at least two years. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating cannabis into clinical cancer care. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Oral agents in cancer treatment: the context for adherence. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Undesirable effects related to oral antineoplastic drugs: comparison between patients' internet narratives and a national pharmacovigilance database. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program. [2022]

9. United States 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. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Novel tetrahydrocurcumin integrated mucoadhesive nanocomposite κ-carrageenan/xanthan gum sponges: a strategy for effective local treatment of oral cancerous and precancerous lesions. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Potential, Limitations and Risks of Cannabis-Derived Products in Cancer Treatment. [2023]