Cannabis for Cancer-Related Symptoms

(CAFCARS Trial)

No longer recruiting at 8 trial locations

Overseen By Alshanee Sharma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pippa Hawley

Must not be taking: CYP1A1, 1A2, 1B1 drugs

Disqualifiers: Substance misuse, Psychosis, Pregnancy, 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: Unknown

Duration: 16-48 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of cannabis oil best treats cancer-related symptoms such as nausea, pain, anxiety, and sleep problems. Researchers are testing three cannabis oil combinations: one with more THC (the component that can cause a high), one with more CBD (a component that does not cause a high), and one with equal amounts of both. The trial also includes a placebo, an oil without active cannabis ingredients. It seeks participants experiencing distress from cancer-related symptoms who are willing to use only the study's cannabis products during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, if you are taking medications that might interact with cannabinoids (CYP1A1, 1A2, and 1B1), you may need to switch to a different medication. Please consult with the trial team for specific guidance.

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

Research has shown that medical cannabis can alleviate cancer-related symptoms such as pain, nausea, and anxiety. This trial tests three cannabis oil combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC and CBD.

For the High THC/Low CBD oil, studies indicate that higher THC levels can reduce symptoms and improve quality of life for cancer patients. However, THC may also cause side effects like dizziness or dry mouth.

The Low THC/High CBD oil is considered safer because CBD is usually well-tolerated. Known for its calming effects, CBD might help manage symptoms without causing the high associated with THC.

For the Equal amounts of THC/CBD oil, research suggests that balanced doses can relieve symptoms. These combinations might be easier to tolerate than those with high THC alone.

Overall, these cannabis oils are considered safe but can have mild side effects. Monitoring the body's response is important, as reactions can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these cannabis oils because they offer a unique approach to managing cancer-related symptoms. Unlike typical treatments like opioids and antiemetics that target pain and nausea through different pathways, these cannabis oils leverage cannabinoids like THC and CBD to potentially provide relief. Each oil is distinct: one has high THC for potent effects, another is high in CBD for a more balanced, calming impact, and a third offers equal amounts of both for a combined effect. This variety allows for tailored symptom management, potentially offering patients personalized relief options that differ from the standard treatments.

What evidence suggests that this trial's cannabis oil treatments could be effective for cancer-related symptoms?

Research has shown that cannabis can help manage cancer-related symptoms such as pain, nausea, anxiety, and sleep problems. In one study, 70%–90% of patients using cannabis reported improvement. This trial will test different formulations of cannabis oil. Participants in one arm will receive High THC/Low CBD oil, which shows promise because THC is known to relieve pain. Another arm will test Low THC/High CBD oil, which may work well because CBD can help reduce anxiety and inflammation. A third arm will evaluate Equal THC/CBD oil, which has been found to improve pain, although it may sometimes cause side effects. Overall, these cannabis oils may provide relief for those experiencing cancer symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Philippa Hawley, FRCPC

Principal Investigator

BC Cancer

Are You a Good Fit for This Trial?

This trial is for adults over 19 with stable cancer-related symptoms like nausea, pain, anxiety, or sleep issues. Participants must not use other cannabis products during the study and should have a life expectancy of at least 4 months. They can't join if they're pregnant, on another trial, have certain mental health conditions or substance misuse disorders.

Inclusion Criteria

I can be reached by phone.

Willing to commit to not taking cannabis in any form other than the study products for the duration of the study

I am 19 years old or older.

Exclusion Criteria

They have any concurrent condition likely to interfere with completion of the study protocol, such as allergy to any component of the study products

I cannot or will not avoid using heavy machinery during the study.

They have an active psychiatric disorder likely, in the investigator's opinion, to interfere with adherence to study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a series of N-of-1 trials with cannabis oil extracts and placebo for cancer-related symptom management

16-48 days

Daily self-administration with regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Cannabis

Trial Overview The trial tests three types of cannabis oil extracts (High THC/Low CBD, Low THC/High CBD, Equal THC/CBD) against a placebo to see which is best for managing cancer-related symptoms. Each participant will try all options in random order to compare effectiveness and safety.

How Is the Trial Designed?

Group I: Low THC/High CBD Cannabis Oil Experimental Treatment 1 Intervention

THC+THCa = 37mg CBD+CBDA = 784mg Total cannabinoids = 821mg (1.37mg/drop) Dried marijuana equivalent = 6g

Group II: High THC/Low CBD Cannabis Oil Experimental Treatment 1 Intervention

THC+THCa = 573 mg CBD+CBDA = 0 mg Total cannabinoids = 573 mg (0.95mg/drop) Dried marijuana equivalent = 5g

Group III: Equal amounts of THC/CBD Cannabis Oil Experimental Treatment 1 Intervention

THC+THCa = 516mg CBD+CBDA = 456mg Total cannabinoids = 972mg (1.62mg/drop) Dried marijuana equivalent = 6g

Group IV: Placebo Oil Placebo Group 1 Intervention

Medium Chain Triglyceride (MCT) oil

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?

Pippa Hawley

Lead Sponsor

Trials

2

Recruited

330+

Published Research Related to This Trial

Medical cannabis, particularly formulations containing THC and CBD, shows potential for managing cancer-associated pain, with some studies indicating effective pain relief at doses as low as 2.7 mg THC combined with CBD.

Despite some positive findings, many studies had small sample sizes and lacked statistical power, highlighting the need for larger, well-designed clinical trials to better understand the efficacy and optimal dosing of cannabis-based therapies for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A selective review of medical cannabis in cancer pain management. Blake, A., Wan, BA., Malek, L., et al.[2022]

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]

Cannabidiol (CBD), a non-intoxicating compound from Cannabis sativa, shows a wide range of therapeutic effects that may be beneficial in managing cancer, based on both preclinical and clinical research.

The article discusses potential mechanisms of action for CBD in cancer treatment and suggests that it could be effectively integrated with traditional cancer therapies to help manage side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) in Cancer Management. O'Brien, K.[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]

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]

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]

Patient forums can significantly enhance pharmacovigilance by providing real-time, uncensored reports of adverse drug events (ADEs) for rare cancers, as demonstrated in a case study on Gastrointestinal Stromal Tumor patients.

Using machine learning algorithms, the study identified that certain side effects, like cognitive impairment and alopecia from avapritinib, were reported at different rates compared to clinical trials, highlighting the potential of patient forums to uncover long-term and novel ADEs not previously documented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers. Dirkson, A., Verberne, S., Kraaij, W., et al.[2022]

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

A review of 166 phase III randomized clinical trials published between 2011 and 2013 revealed frequent misreporting of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0), indicating a significant issue in adherence to established guidelines.

Inappropriate grading of toxicities was common, with serious conditions like febrile neutropenia often graded too low, and less severe conditions like alopecia graded too high, which could mislead clinicians and affect treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and misuse of common terminology criteria for adverse events in cancer clinical trials. Zhang, S., Liang, F., Tannock, I.[2018]

The study involved 127 cancer patients undergoing chemotherapy or radiation therapy, and it confirmed that most adverse event (AE) terms in the PRO-CTCAE library were easily understood by patients, regardless of their education level.

Minor modifications were made to 17 AE terms to enhance clarity and comprehension, ultimately supporting the content validity of the PRO-CTCAE for accurately capturing patient-reported outcomes during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Hay, JL., Atkinson, TM., Reeve, BB., et al.[2022]

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]

Cannabidiol (CBD), a non-psychoactive compound from Cannabis sativa L., shows promising anti-tumor effects across various cancer types, as highlighted by recent in vitro and in vivo studies.

CBD exhibits multiple mechanisms of action, including anti-proliferative, pro-apoptotic, and anti-inflammatory properties, making it a potential therapeutic option in cancer treatment with a favorable pharmacological profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol-from Plant to Human Body: A Promising Bioactive Molecule with Multi-Target Effects in Cancer. Kis, B., Ifrim, FC., Buda, V., et al.[2023]

THC, CBD, and standardized cannabis extracts (F1) effectively inhibited the migration and invasion of human breast cancer cells (MCF-7) by targeting multiple signaling pathways, including FAK, Akt, and NF-κB.

CBD and F1 also induced apoptosis in MCF-7 cells through the Bcl-2/caspase-3 pathways, suggesting their potential as therapeutic agents in preventing breast cancer metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoids and standardized cannabis extracts inhibit migration, invasion, and induce apoptosis in MCF-7 cells through FAK/MAPK/Akt/NF-κB signaling. Suttithumsatid, W., Sukketsiri, W., Panichayupakaranant, P.[2023]

Modern multimodal tumor therapies, which include radiotherapy, chemotherapy, immunotherapy, and targeted therapies, can lead to significant acute and long-lasting side effects that negatively impact patients' quality of life and survival.

The paper highlights the need for better characterization of side effects from newly approved therapies and provides recommendations for monitoring and managing these effects in specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onco-Cardiology: Consensus Paper of the German Cardiac Society, the German Society for Pediatric Cardiology and Congenital Heart Defects and the German Society for Hematology and Medical Oncology. Rassaf, T., Totzeck, M., Backs, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8869992/

Cannabidiol (CBD) in Cancer Management - PMC Research indicates the CBD may have potential for the treatment of cancer, including the symptoms and signs associated with cancer and its treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03948074

NCT03948074 | Cannabis For Cancer-Related Symptoms The three active treatments will be the following cannabis oil extract combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD. THC = ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12289739/

Medicinal cannabis for symptom control in advanced cancer This study assessed whether a 1:1 10 mg/ml THC:CBD combination oil could improve total symptom burden in patients with advanced cancer over that ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.12020

A randomized, double-blind controlled trial of medicinal ... A 1:1 THC:CBD medicinal cannabis oil resulted in a statistically significant improvement in cancer-related pain at the expense of increased psychomimetic ...

5. 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, ...

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

Cannabis and Cannabinoids in Adults With Cancer Outside of a clinical trial, clinicians should not recommend that adults with cancer use 300 mg or more per day of oral CBD to manage symptom ...

7. macmillan.org.uk macmillan.org.uk/cancer-information-and-support/treatment/coping-with-treatment/complementary-therapies/cannabis-oil

Cannabis oil and cancer There is no reliable, medical evidence to show whether cannabis, in any form, can effectively and safely treat cancer in humans.