CBD for Glioblastoma Anxiety

Overseen By Rosemary Smith, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mclean Hospital

Must be taking: Temozolomide

Must not be taking: Valproate, Cannabis

Disqualifiers: Substance use, Psychotic, Bipolar, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Glioblastoma (GBM) is the most common malignant brain tumor among adults. As the diagnosis is generally considered terminal, patients with GBM often suffer from anxiety and other comorbid conditions, including depression, pain, and sleep disturbance, all of which significantly impact their quality of life. Previous studies have demonstrated the potential of cannabinoids, particularly cannabidiol (CBD), to improve the aforementioned symptoms without conferring significant risks or side effects. Further, recent in-vitro and in-vivo work suggests potential cytotoxic and anti-tumor effects of CBD and other cannabinoids. This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product on measures of anxiety, pain, and quality of life in newly-diagnosed GBM patients undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor progression will also be assessed. The proposed clinical trial will provide important information that does not currently exist regarding the potential efficacy of a novel full-spectrum, ultra-high CBD product to address clinical symptoms in patients with GBM.

Will I have to stop taking my current medications?

The trial requires that your medication and therapy regimens be stable for at least 1 month before starting, except for new glioblastoma treatments or radiation. If you are taking valproate, you will need to stop due to potential interactions.

Is CBD safe for humans?

CBD (Cannabidiol) has been studied for various conditions and is generally considered safe for humans. In studies involving patients with brain tumors and epilepsy, CBD was well-tolerated and showed potential benefits, although more research is needed to fully understand its safety profile. ^{1 2 3 4 5}

How does the drug CBD differ from other treatments for glioblastoma anxiety?

CBD is unique because it is a non-intoxicating compound that may have antitumor properties and can alter the tumor microenvironment, potentially improving survival in glioblastoma patients. Unlike standard treatments, CBD can be administered as an inhalant, which may offer a novel way to manage tumor growth and anxiety in these patients. ^{1 3 4 5 6}

What evidence supports the effectiveness of the drug CBD for anxiety in glioblastoma patients?

Research shows that CBD, a component of the drug Epidiolex, has antitumor properties and can improve survival in glioblastoma patients when used alongside standard treatments. Additionally, CBD has been effective in reducing seizures in patients with brain tumor-related epilepsy, suggesting its potential benefits in managing symptoms associated with brain tumors. ^{1 3 4 5 7}

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed glioblastoma who are fluent in English, have a Karnofsky Performance Scale score of 60 or higher, and experience moderate anxiety. They must be undergoing standard cancer treatment but not using cannabis products more than once a month or participating in other clinical trials.

Inclusion Criteria

My medication or therapy for conditions other than glioblastoma has been stable for at least 1 month.

I have a new diagnosis of glioblastoma and am following the standard treatment plan.

Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study

Current substance use disorder, psychotic disorder, bipolar disorder, or eating disorder

I do not have any serious illnesses like heart, liver, or kidney diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a full-spectrum, hemp-derived ultra-high CBD product or placebo for 8 weeks along with standard of care treatment

8 weeks

Weekly assessments (in-person or virtual)

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

• Cannabidiol (CBD)
• Placebo

Trial Overview The study tests if a high-CBD hemp product can reduce anxiety and improve quality of life in glioblastoma patients during an 8-week trial. It's double-blind, meaning neither the researchers nor participants know who gets CBD or placebo. The effect on tumor growth is also being studied.

How Is the Trial Designed?

Group I: Cannabidiol (CBD) Solution Plus Standard of Care (SOC) Experimental Treatment 1 Intervention

Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment

Group II: Placebo Placebo Group 1 Intervention

Placebo solution administered for 8 weeks along with standard of care treatment

Cannabidiol (CBD) is already approved in United States, European Union for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Center for Medicinal Cannabis Research

Collaborator

Trials

19

Recruited

630+

Published Research Related to This Trial

In a case series of nine patients with Grade IV glioblastoma multiforme, the addition of 400 mg of cannabidiol (CBD) to standard treatment resulted in a mean survival time of 22.3 months, which is significantly longer than the typical 14 to 16 months expected with conventional therapies.

All but one patient in the study remained alive at the time of reporting, suggesting that CBD may have a potential role as a tumor-inhibiting agent when used alongside standard treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Treatment of Malignant Brain Tumours With CBD - A Case Series and Review of the Literature. Likar, R., Koestenberger, M., Stultschnig, M., et al.[2019]

Cannabidiol (CBD), a nonpsychoactive cannabinoid, significantly reduced the growth and viability of human glioma cell lines in vitro, with an IC(50) of 25 microM, indicating its potential as an effective antitumor agent.

In vivo studies showed that CBD also inhibited the growth of glioma cells in mice, suggesting its therapeutic potential for treating tumors without the psychoactive effects associated with other cannabinoids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor effects of cannabidiol, a nonpsychoactive cannabinoid, on human glioma cell lines. Massi, P., Vaccani, A., Ceruti, S., et al.[2013]

Combining temozolomide (TMZ) with THC and CBD, especially in higher CBD ratios, shows promising antitumoral effects against glioblastoma multiforme (GBM) in preclinical models, including those derived from glioma initiating cells (GICs).

The combination treatment not only reduced tumor growth in xenografts but also improved survival rates in animal models, suggesting a potential new therapeutic strategy for targeting the aggressive nature of GBM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Glioma Initiating Cells with A combined therapy of cannabinoids and temozolomide. López-Valero, I., Saiz-Ladera, C., Torres, S., et al.[2019]

In a pilot study involving three patients with epilepsy related to brain tumors, two patients experienced a reduction in seizure frequency, and all three reported less severe seizures after using pharmaceutical grade cannabidiol (CBD).

These promising results indicate that CBD may be a safe and effective treatment option for patients with refractory seizures due to brain tumors, warranting further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cannabidiol for seizure management in patients with brain tumor-related epilepsy. Warren, PP., Bebin, EM., Nabors, LB., et al.[2019]

Cannabidiol (CBD) enhances the effectiveness of gamma-irradiation in treating glioblastoma (GBM) by activating specific signaling pathways that promote cancer cell death, particularly through the MAPK p38 and JNK pathways.

CBD treatment shows minimal adverse effects on neural stem/progenitor cells and astrocytes, suggesting it could be a safe adjunct therapy to improve radiosensitivity in GBM without harming healthy brain cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of human glioblastoma cell death by combined treatment of cannabidiol, γ-radiation and small molecule inhibitors of cell signaling pathways. Ivanov, VN., Wu, J., Hei, TK.[2019]

Cannabidiol (CBD) demonstrated a dose-dependent ability to reduce the growth and survival of glioblastoma multiforme (GBM) cells, but it did not show preferential activity towards cancer cells over normal neural progenitor cells, indicating potential safety concerns.

When combined with standard DNA-damaging agents like temozolomide, carmustine, or cisplatin, CBD produced some synergistic effects in killing GBM cells, but also showed antagonistic responses at low concentrations, suggesting a complex interaction that may limit its therapeutic effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Analyses of Synergistic Responses between Cannabidiol and DNA-Damaging Agents on the Proliferation and Viability of Glioblastoma and Neural Progenitor Cells in Culture. Deng, L., Ng, L., Ozawa, T., et al.[2018]

Inhaled cannabidiol (CBD) significantly inhibited glioblastoma (GBM) tumor growth in a murine model, suggesting its potential as a therapeutic adjunct for this aggressive brain cancer.

CBD altered the tumor microenvironment by reducing key inflammatory factors and enhancing immune responses, indicating a dual mechanism of action that could improve treatment outcomes for GBM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalant Cannabidiol Inhibits Glioblastoma Progression Through Regulation of Tumor Microenvironment. Khodadadi, H., Salles, ÉL., Alptekin, A., et al.[2023]

Citations

1. Greece pubmed.ncbi.nlm.nih.gov

Concomitant Treatment of Malignant Brain Tumours With CBD - A Case Series and Review of the Literature. [2019]

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

Antitumor effects of cannabidiol, a nonpsychoactive cannabinoid, on human glioma cell lines. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Targeting Glioma Initiating Cells with A combined therapy of cannabinoids and temozolomide. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The use of cannabidiol for seizure management in patients with brain tumor-related epilepsy. [2019]

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

Regulation of human glioblastoma cell death by combined treatment of cannabidiol, γ-radiation and small molecule inhibitors of cell signaling pathways. [2019]

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

Quantitative Analyses of Synergistic Responses between Cannabidiol and DNA-Damaging Agents on the Proliferation and Viability of Glioblastoma and Neural Progenitor Cells in Culture. [2018]

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

Inhalant Cannabidiol Inhibits Glioblastoma Progression Through Regulation of Tumor Microenvironment. [2023]