Cannabis for Palliative Care in Cancer

(ARCTiC Trial)

Overseen By Kyle Chrystal, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 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: 2

Duration: 8 weeks

185 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how cannabis might help cancer patients with pain, sleep, and mood issues. It will compare two types of CBD (cannabidiol) treatments: one with THC (a compound that can cause a "high") and one without, against a placebo. The goal is to assess whether these treatments can improve quality of life and how they affect cognitive function, including thinking and memory. Suitable candidates include those with a solid tumor diagnosis who experience sleep, pain, or mood problems and have not used cannabis regularly in the last six months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important findings.

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.

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

Research has shown that CBD (Cannabidiol) may help manage cancer symptoms by reducing pain, improving sleep, and lifting mood. However, it can sometimes affect thinking and memory, which cancer patients should consider.

Full-Spectrum Hemp-Derived CBD (fsCBD) contains both CBD and THC (Delta-9-tetrahydrocannabinol). This combination might increase side effects like trouble thinking clearly. Some people might handle it well, while others may notice these side effects.

Broad-Spectrum Hemp-Derived CBD (bsCBD) contains only CBD without THC, which might lower the risk of thinking problems. However, effects can differ from person to person.

Both types of CBD are still under study to better understand their safety. Since this trial is in Phase 2, earlier tests have shown some safety, but more research is needed to confirm how well it is tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these cannabis-based treatments for palliative care in cancer because they offer a novel approach to managing symptoms. Unlike traditional pain relief methods such as opioids, which can have significant side effects and dependency issues, Full-Spectrum Hemp-Derived CBD (fsCBD) includes both CBD and a small amount of THC, potentially enhancing its pain-relieving effects without high levels of psychoactivity. Broad-Spectrum Hemp-Derived CBD (bsCBD) contains only CBD, which may provide symptom relief without any psychoactive effects at all. These treatments could offer a more natural and potentially safer alternative for managing cancer symptoms, which is why they are gaining attention in the medical community.

What evidence suggests that this trial's treatments could be effective for cancer patients?

Research has shown that cannabis can help cancer patients with pain, sleep, and mood issues. In this trial, participants may receive either full-spectrum hemp-derived CBD (fsCBD), which includes THC, or broad-spectrum hemp-derived CBD (bsCBD), which does not contain THC. Studies have found that full-spectrum hemp-derived CBD might lower pain levels and boost mood. Reviews also support that cannabis can help with pain and improve overall quality of life. Broad-spectrum CBD has also shown promise in alleviating these symptoms. A meta-analysis strongly supports using medical cannabis to improve health outcomes for cancer patients. Overall, these findings suggest that both types of CBD could effectively manage symptoms in cancer care. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabis

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.

How Is the Trial Designed?

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, United States, European Union for the following indications:

Approved in Canada as Cannabis for:

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

Approved in United States as Cannabis for:

• Seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
• Nausea and vomiting associated with chemotherapy

Approved in European Union as Cannabis for:

• Spasticity associated with multiple sclerosis
• Chronic pain

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

Published Research Related to This Trial

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]

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]

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]

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]

In a study of 2,431 patients using cannabis for palliative care, a higher ratio of tetrahydrocannabinol (THC) to cannabidiol (CBD) was linked to improved self-reported efficacy in reducing neuropathic pain, insomnia, and depressive symptoms.

The study found that while a higher THC:CBD ratio was beneficial for some symptoms, it did not significantly affect PTSD-related flashbacks or anorexia, and anxiety symptoms showed the best response at a balanced 1:1 THC to CBD ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of Tetrahydrocannabinol versus Cannabidiol for Common Palliative Care Symptoms. Casarett, DJ., Beliveau, JN., Arbus, MS.[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]

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