Medical Cannabis for Pancreatic Cancer

(CanPan Trial)

Overseen By Alissa Gavenda, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: HealthPartners Institute

Must not be taking: Immunotherapy, Non-standard chemotherapy

Disqualifiers: Alzheimer's, Epilepsy, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not be using THC products regularly and cannot be on immunotherapy or non-standard chemotherapy.

What data supports the effectiveness of the drug Medical Cannabis for treating pancreatic cancer?

Research suggests that certain components of cannabis, like cannabinoids, may help slow down tumor growth and improve survival in animal models of pancreatic cancer. Additionally, cannabis is known to help manage symptoms like pain and nausea in cancer patients, which can improve quality of life. ^{1 2 3 4 5}

Is medical cannabis safe for humans?

Medical cannabis has been used for various conditions, but it can have side effects, including gastrointestinal issues like cannabis hyperemesis syndrome (severe vomiting) and acute pancreatitis (inflammation of the pancreas). While some studies suggest it might reduce the risk of alcohol-induced pancreatitis, it can also cause pancreatitis in some users. ^{6 7 8 9 10}

How is the drug medical cannabis unique in treating pancreatic cancer?

Medical cannabis, particularly a non-psychoactive derivative called FBL-03G, shows promise in treating pancreatic cancer by increasing cancer cell death and slowing tumor growth, which is different from traditional treatments that often struggle with resistance and the tumor's protective environment. ^{2 11 12 13 14}

What is the purpose of this trial?

Many patients with Pancreatic Ductal Adenocarcinoma (PDAC) experience burdensome and difficult-to-treat symptoms. The impact of multiple symptoms (called "symptom burden") can negatively affect a patient's quality of life, decrease their ability to tolerate cancer treatments, and lead to worse survival. Current approaches to manage PDAC-associated symptoms often work poorly, with most patients reporting a moderate to severe symptom burden. Therefore, there is an urgent need for treatments that improve these symptoms in patients with PDAC, and data suggests that medical cannabis can help. In this research study, we are examining the usefulness of using medical cannabis in patients with pancreatic cancer to further study how cannabis can impact their symptom burden.

Eligibility Criteria

This trial is for patients with advanced pancreatic cancer who experience significant symptoms from their disease. Participants should have a diagnosis of Pancreatic Ductal Adenocarcinoma and be experiencing a high symptom burden that affects their quality of life.

Inclusion Criteria

Must be a resident of Minnesota

Must be willing to be registered in the Minnesota Medical Cannabis Program and follow all rules and requirements of the state program

My pancreatic cancer is advanced and surgery isn't planned within 4 months.

Exclusion Criteria

Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis)

Patients with Alzheimer's dementia, epilepsy, or history of traumatic brain injury

Uncontrolled acute or chronic medical conditions, psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the early group receive medical cannabis immediately, while the delayed group abstains for the first 8 weeks

8 weeks

Weekly PRO assessments, QOL every 4 weeks

Extended Treatment

Early group continues cannabis for another 8 weeks; delayed group starts cannabis

8 weeks

PRO/QOL every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Medical Cannabis

Trial Overview The study is testing the effectiveness of medical cannabis in reducing the symptom burden for patients with advanced pancreatic cancer. It aims to see if cannabis can improve quality of life, enhance tolerance to cancer treatments, and potentially impact survival.

Participant Groups

Group I: Early Cannabis Experimental Treatment 1 Intervention

Group II: Delayed Cannabis Experimental Treatment 1 Intervention

Medical Cannabis is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Medical Cannabis for:

• Severe and chronic pain
• Multiple sclerosis and muscle spasms
• Severe nausea and vomiting caused by cancer treatment
• Epilepsy and seizures
• Alzheimer's disease
• Amyotrophic lateral sclerosis (ALS)
• HIV/AIDS
• Crohn's disease
• Glaucoma
• Migraine
• Anorexia
• Extreme weight loss and weakness (wasting syndrome)
• Irritable bowel syndrome
• Post-traumatic stress disorder

Approved in European Union as Cannabis-based medicinal products for:

• Severe epilepsy
• Multiple sclerosis
• Nausea and vomiting caused by cancer treatment

Approved in Canada as Medical Cannabis for:

• Severe pain
• Nausea and vomiting caused by cancer treatment
• Muscle spasms caused by multiple sclerosis
• Seizures caused by epilepsy

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Findings from Research

Cannabinoid therapies, including pharmaceuticals and botanical forms, are versatile treatment options for patients with malignant diseases, effectively addressing symptoms like pain, chemotherapy-induced nausea, and anorexia.

These therapies not only improve quality of life for cancer patients but may also enhance adherence to conventional treatments like chemotherapy and radiation, potentially modifying the disease's progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A user's guide to cannabinoid therapies in oncology. Maida, V., Daeninck, PJ.[2019]

FBL-03G, a non-cannabinoid derivative of cannabis, significantly increased apoptosis and decreased survival in pancreatic cancer cells in vitro, suggesting its potential as a treatment option.

In animal models, FBL-03G demonstrated therapeutic efficacy by delaying tumor progression and significantly increasing survival rates compared to control groups, highlighting its promise for treating pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flavonoid Derivative of Cannabis Demonstrates Therapeutic Potential in Preclinical Models of Metastatic Pancreatic Cancer. Moreau, M., Ibeh, U., Decosmo, K., et al.[2020]

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]

Cannabis has shown potential benefits as an adjunctive treatment for chemotherapy-induced nausea, vomiting, and cancer-related pain, but its use should be carefully assessed by physicians due to the need for more reliable scientific data and guidelines.

Current evidence does not support the use of cannabis as a primary treatment for cancer; its effects on conditions like anorexia, insomnia, and anxiety are promising but not yet substantial enough to warrant initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Cannabis in Oncology: a Valuable Unappreciated Remedy or an Undesirable Risk? Abu-Amna, M., Salti, T., Khoury, M., et al.[2022]

Cannabinoids, particularly cannabidiol (CBD) and tetrahydrocannabinol (THC), have shown promising anticancer properties in pancreatic cancer through in vitro studies, demonstrating tumor growth inhibition and pro-apoptotic effects via cannabinoid receptors.

While there is potential for cannabinoids to enhance cancer treatment, especially when combined with chemotherapy, there are currently no clinical studies confirming their effectiveness in patients with pancreatic cancer, highlighting a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Use of Cannabinoids for the Treatment of Pancreatic Cancer. Sharafi, G., He, H., Nikfarjam, M.[2020]

A review of 25 articles involving 45 patients revealed that cannabis-induced acute pancreatitis predominantly affects young males, with a mean age of 29.2 years, and the most common symptoms include abdominal pain, nausea, and vomiting.

Despite the majority of patients showing mild pancreatitis on ultrasound, the overall prognosis is good, with most patients achieving full recovery, highlighting the importance of considering cannabis use in diagnosing acute pancreatitis for timely treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pancreatitis as a rare adverse event among cannabis users: A systematic review. Jaiswal, V., Mukherjee, D., Batra, N., et al.[2023]

In a study of 2991 patients over three years, only 3.6% experienced moderate or severe adverse events (AEs) after starting medical cannabis, indicating a relatively low incidence of serious side effects in real-world use.

Common mild AEs included dizziness, nausea, and somnolence, with variations depending on the method of consumption and cannabinoid content, suggesting that healthcare providers should consider these factors when prescribing medical cannabis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. Hachem, Y., Moride, Y., Castilloux, AM., et al.[2023]

Cannabis is widely used in the US, with at least 18% of the population using it, primarily for recreational purposes, but it also has therapeutic applications for conditions like pain management and inflammation.

Despite its benefits, cannabis use is linked to several gastrointestinal disorders, including gastroesophageal reflux disease, pancreatitis, and peptic ulcer disease, highlighting the need for awareness of its potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis Use and Associated Gastrointestinal Disorders: A Literature Review. Adenusi, AO., Magacha, HM., Nwaneki, CM., et al.[2023]

Cannabinoids may help improve symptoms in patients with inflammatory bowel disease (IBD), but they do not appear to have a significant anti-inflammatory effect, as shown by observational studies and small clinical trials.

There is a lack of evidence linking cannabis use to acute pancreatitis, but cannabis hyperemesis syndrome (CHS) remains a concern, with complete abstinence from cannabinoids being the recommended treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis in Gastroenterology: Watch Your Head! A Review of Use in Inflammatory Bowel Disease, Functional Gut Disorders, and Gut-Related Adverse Effects. Nasser, Y., Woo, M., Andrews, CN.[2022]

Cannabis use appears to reduce the incidence of acute and chronic pancreatitis in individuals who also abuse alcohol, with adjusted odds ratios indicating a significant protective effect (aOR: 0.50 for acute pancreatitis and aOR: 0.77 for chronic pancreatitis).

In contrast, cannabis use does not affect the incidence of pancreatitis in patients with gallstones and is associated with an increased incidence of chronic pancreatitis among non-alcohol-non-gallstones users (aOR: 1.28), suggesting that the effects of cannabis on pancreatitis may vary based on the underlying cause.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Risk of Alcohol-Induced Pancreatitis With Cannabis Use. Adejumo, AC., Akanbi, O., Adejumo, KL., et al.[2020]

Only 8% of cancer survivors reported using cannabis in the past year, compared to 15% of individuals without a cancer history, indicating lower prevalence among cancer survivors.

Pain levels were a significant predictor of cannabis use in both groups, suggesting that those with higher pain are more likely to use cannabis, regardless of cancer history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis use among cancer survivors in the United States: Analysis of a nationally representative sample. Do, EK., Ksinan, AJ., Kim, SJ., et al.[2022]

There is inconsistent evidence linking cannabis smoking to cancers of the respiratory system, with some case reports in young adults but no strong epidemiological support.

While THC and cannabinoids may help alleviate cancer symptoms like nausea and pain, there is currently no evidence of their anticancer effects in humans, highlighting the need for safe medical use without psychoactive side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids and cancer: causation, remediation, and palliation. Hall, W., Christie, M., Currow, D.[2022]

In a survey of 523 cancer patients, 54% reported using cannabis since their diagnosis, with 42% using it during active treatment, primarily for managing sleep disturbances, pain, and mood issues.

Patients experiencing moderate pain were over twice as likely to use cannabis, indicating its potential role in pain management for cancer survivors, while mood and general health did not significantly influence cannabis use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis use is associated with pain severity and interference among cancer survivors. Nugent, SM., Latour, E., Lim, J., et al.[2023]

In a study of 24 cancer patients using medical cannabis (MC), most received their MC certifications from new professionals after brief consultations, leading to minimal medical oversight in their cannabis use.

Patients often relied on personal experimentation and nonmedical sources for information about MC, expressing a strong desire for better guidance from their established medical teams regarding its use for symptom management and cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patients' experiences with medicinal cannabis-related care. Braun, IM., Nayak, MM., Revette, A., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A user's guide to cannabinoid therapies in oncology. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Flavonoid Derivative of Cannabis Demonstrates Therapeutic Potential in Preclinical Models of Metastatic Pancreatic Cancer. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating cannabis into clinical cancer care. [2018]

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

Medical Cannabis in Oncology: a Valuable Unappreciated Remedy or an Undesirable Risk? [2022]

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

Potential Use of Cannabinoids for the Treatment of Pancreatic Cancer. [2020]

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

Acute pancreatitis as a rare adverse event among cannabis users: A systematic review. [2023]

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

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. [2023]

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

Cannabis Use and Associated Gastrointestinal Disorders: A Literature Review. [2023]

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

Cannabis in Gastroenterology: Watch Your Head! A Review of Use in Inflammatory Bowel Disease, Functional Gut Disorders, and Gut-Related Adverse Effects. [2022]

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

Reduced Risk of Alcohol-Induced Pancreatitis With Cannabis Use. [2020]

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

Cannabis use among cancer survivors in the United States: Analysis of a nationally representative sample. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Cannabinoids and cancer: causation, remediation, and palliation. [2022]

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

Cannabis use is associated with pain severity and interference among cancer survivors. [2023]

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

Cancer patients' experiences with medicinal cannabis-related care. [2023]