Cannabis for Palliative Care in Cancer

(ARCTiC Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Colorado, Boulder

Must not be taking: Anti-epileptics, Antipsychotics, CYP inducers, others

Disqualifiers: Illegal drug use, Liver disease, Psychosis, others

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, you cannot use anti-epileptic, anti-psychotic medications, or those that interact with Epidiolex. If you're on any of these, you might need to discuss alternatives with your doctor.

What data supports the effectiveness of the drug Cannabis for Palliative Care in Cancer?

Research shows that cannabis, particularly THC and CBD, can help reduce symptoms like pain, nausea, and insomnia in cancer patients receiving palliative care. Studies indicate that both THC-dominant and CBD-dominant cannabis products can improve sleep quality, pain intensity, and overall symptom burden, with THC showing a slight advantage for sleep duration. ^{1 2 3 4 5}

Is cannabis safe for use in palliative care for cancer patients?

Cannabis, including THC and CBD, is generally considered safe for use in palliative care for cancer patients, with manageable short- and long-term side effects that usually subside after stopping the drug. Common side effects include drowsiness, but the doses used in studies are generally well tolerated. ^{1 3 6 7 8}

How does the drug cannabis differ from other treatments for palliative care in cancer?

Cannabis, containing THC and CBD, is unique because it targets multiple symptoms like pain, nausea, and anxiety simultaneously, and can be used alongside standard treatments without depressing the respiratory system. Its combination of THC and CBD can also provide mood improvement and anti-inflammatory effects, which are not typically offered by standard palliative care medications. ^{1 2 4 8 9}

Eligibility Criteria

This trial is for cancer patients experiencing pain, sleep disturbances, and mood issues. Participants should be interested in using hemp-derived CBD to manage these symptoms. Specific eligibility criteria are not provided, but typically include factors like age range, cancer type/stage, and overall health status.

Inclusion Criteria

Able to provide informed consent

I want to use cannabis for symptom relief.

Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months

Exclusion Criteria

Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days

I am not taking any medications that interact badly with Epidiolex.

I am currently taking medication for psychosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either full-spectrum or broad-spectrum hemp-derived CBD with or without THC, or placebo for 8 weeks

8 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Cannabis (Cannabinoid)

Trial Overview The study compares the effects of two types of Cannabidiol (CBD) - one with THC (fsCBD) and one without THC (bsCBD), against a placebo. It aims to assess their impact on sleep quality, pain levels, mood changes, cognitive function, and life quality in 185 cancer patients.

Participant Groups

Group I: Full-Spectrum Hemp-Derived CBD (fsCBD) Experimental Treatment 1 Intervention

8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)

Group II: Broad-Spectrum Hemp-Derived CBD (bsCBD) Experimental Treatment 1 Intervention

8 weeks of use of a daily dose of cannabis (200mg CBD)

Group III: Placebo Placebo Group 1 Intervention

Cannabis is already approved in Canada for the following indications:

Approved in Canada as Cannabis for:

• Chronic pain
• Nausea and vomiting associated with chemotherapy
• Spasticity associated with multiple sclerosis

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

Findings from Research

Cannabis and cannabinoid-based medicines have shown favorable outcomes in alleviating chemotherapy-induced nausea and vomiting, as well as managing cancer-related pain, suggesting they can be beneficial in palliative oncology.

While short- and long-term side effects of cannabis use appear manageable and diminish after stopping the drug, further research is necessary to fully understand its efficacy and safety before it can be integrated into standard oncology treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis Use in Palliative Oncology: A Review of the Evidence for Popular Indications. Turgeman, I., Bar-Sela, G.[2017]

This study will evaluate the efficacy and safety of a 1:1 THC/CBD cannabinoid preparation in managing symptom distress in 150 advanced cancer patients through a randomized, placebo-controlled trial, making it the first of its kind in this area.

Participants will undergo a 2-week titration phase to find an effective dose for symptom relief, followed by a 2-week assessment period, allowing for a comprehensive understanding of the treatment's impact on various symptoms and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Hardy, J., Haywood, A., Gogna, G., et al.[2021]

In a study of 108 oncology patients, both THC-dominant and CBD-dominant cannabis treatments showed significant improvements in various cancer-related symptoms, including pain intensity and sleep quality, over a one-month period.

There were no significant safety differences among THC-dominant, CBD-dominant, and mixed cannabis treatments, suggesting that CBD-dominant products can be effective alternatives to THC-dominant products for managing cancer symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Medical Cannabis Treatment Regimens Produced Beneficial Effects among Palliative Cancer Patients. Aviram, J., Lewitus, GM., Vysotski, Y., et al.[2020]

A qualitative study involving 10 palliative care patients revealed that most participants support the use of cannabinoid-based medicines (CBMs) for symptom relief, distinguishing it from recreational use.

Patients identified several obstacles to CBM prescription, including the need for better information on side effects and a safe medical framework, suggesting that training healthcare professionals could enhance the integration of CBMs in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Related Barriers to the Prescription of Cannabinoid-Based Medicines in Palliative Care: A Qualitative Approach. Kalonji, P., Revol, A., Broers, B., et al.[2022]

A systematic review of 34 trials found little evidence supporting the effectiveness of cannabinoids as an adjuvant or analgesic for cancer pain, leading to a recommendation against their use for this purpose.

The review highlighted inconsistent evidence regarding the risks and adverse events associated with cannabinoid use in cancer patients, emphasizing the need for careful consideration of potential harms, especially when combined with treatments like checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MASCC guideline: cannabis for cancer-related pain and risk of harms and adverse events. To, J., Davis, M., Sbrana, A., et al.[2023]

A pilot trial involving 21 advanced cancer patients showed that using medicinal cannabis (CBD and THC) for symptom control in palliative care is feasible, with 86% of participants completing the primary outcome measure at day 14.

The study found that the median maximum tolerated doses were 300 mg/day for CBD and 10 mg/day for THC, with 43% of patients experiencing a significant reduction in symptom distress, although drowsiness was the most common adverse event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-Label Pilot Study Testing the Feasibility of Assessing Total Symptom Burden in Trials of Cannabinoid Medications in Palliative Care. Good, PD., Greer, RM., Huggett, GE., et al.[2021]

Cannabinoids, including THC and CBD, have shown potential in treating cancer-related symptoms such as nausea, pain, and anxiety, with THC and nabilone also aiding in appetite stimulation, while CBD is noted for its anxiolytic and antidepressive properties without psychotropic effects.

Animal studies indicate that high doses of CBD and THC can significantly reduce glioma tumor volumes, with enhanced effects when combined with treatments like X-rays or temozolomide, suggesting cannabinoids may be beneficial in palliative care for brain tumor patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cannabis in supportive care and treatment of brain tumor. Likar, R., Nahler, G.[2020]

Cannabinoids show potential in managing various symptoms in cancer and palliative care patients, including pain, spasticity, and nausea, despite their limited overall efficacy.

They have a favorable safety profile, particularly as they do not depress the respiratory system, making them a useful adjunct to existing treatments, especially in combination with opioids for neuropathic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospects for the Use of Cannabinoids in Oncology and Palliative Care Practice: A Review of the Evidence. Dzierżanowski, T.[2020]

References

1. Israel pubmed.ncbi.nlm.nih.gov

Cannabis Use in Palliative Oncology: A Review of the Evidence for Popular Indications. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). [2021]

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

Short-Term Medical Cannabis Treatment Regimens Produced Beneficial Effects among Palliative Cancer Patients. [2020]

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

Benefit of Tetrahydrocannabinol versus Cannabidiol for Common Palliative Care Symptoms. [2020]

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

Patient-Related Barriers to the Prescription of Cannabinoid-Based Medicines in Palliative Care: A Qualitative Approach. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

MASCC guideline: cannabis for cancer-related pain and risk of harms and adverse events. [2023]

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

An Open-Label Pilot Study Testing the Feasibility of Assessing Total Symptom Burden in Trials of Cannabinoid Medications in Palliative Care. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The use of cannabis in supportive care and treatment of brain tumor. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Prospects for the Use of Cannabinoids in Oncology and Palliative Care Practice: A Review of the Evidence. [2020]