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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of a CBD product (Cannabidiol, or Epidiolex) on anxiety, pain, and quality of life in individuals with newly diagnosed glioblastoma, a type of brain tumor. Researchers aim to determine if CBD can affect tumor growth. Participants will receive either a special CBD formula or a placebo alongside their usual cancer treatment. Individuals recently diagnosed with glioblastoma, experiencing moderate anxiety, and undergoing standard treatment may be eligible to participate. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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

Research has shown that cannabidiol (CBD) is generally safe for patients. In studies involving individuals with glioblastoma, CBD did not cause major side effects, indicating its relative safety. Some research even suggests that CBD might help these patients live longer. Although CBD may not be entirely risk-free, the evidence so far supports its safety when used alongside standard treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glioblastoma?

Unlike the standard treatments for glioblastoma anxiety, which often include medications like benzodiazepines or antidepressants, the use of Cannabidiol (CBD) offers a novel approach. CBD is derived from hemp and provides potential therapeutic effects without the psychoactive properties of THC found in marijuana. Researchers are excited about this treatment because it targets the endocannabinoid system, which may help reduce anxiety more naturally and with fewer side effects. Additionally, the full-spectrum, ultra-high CBD solution is administered alongside standard care, potentially enhancing overall treatment efficacy and offering a new avenue for managing anxiety in glioblastoma patients.

What evidence suggests that this treatment might be an effective treatment for glioblastoma anxiety?

Research has shown that CBD (cannabidiol), which participants in this trial may receive, might help with anxiety, pain, and improve the quality of life for people with glioblastoma (GBM), a type of brain cancer. Studies have found that CBD can slow the growth of glioma cells, the cancer cells in the brain. Additionally, CBD may enhance the effectiveness of some GBM treatments, possibly leading to longer survival. In animal studies, CBD demonstrated anti-cancer effects, especially when combined with other compounds like THC. Overall, early evidence suggests that CBD could be a promising option to manage symptoms and possibly influence tumor growth in GBM patients. ^{3 5 6 7 8}

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

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

Fluent in English

Endorses at least moderate levels of anxiety (on the BAI or OASIS) at the screening visit

Exclusion Criteria

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

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

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

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11238413/

From bench to bedside: the application of cannabidiol in glioma CBD inhibits the migration, invasion, and angiogenesis of glioma cells. Gliomas, particularly GBM, pose a grave threat to patient survival.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8962752/

Cannabidiol inhibits RAD51 and sensitizes glioblastoma to ... This study demonstrates that CBD produces enhancement of TMZ antitumor activity selectively in MGMT-methylated GBM leading to prolong survival.

3. cmcr.ucsd.edu cmcr.ucsd.edu/index.php/news-2/homeblog/401-a-clinical-trial-of-a-hemp-derived-ultra-high-cannabidiol-product-for-anxiety-and-pain-in-glioblastoma-patients

A clinical trial of a hemp-derived, ultra-high cannabidiol ... We hypothesize that GBM patients treated with the study product (N=24) will experience a reduction in selfreported ratings of anxiety and concurrent improvement ...

4. trialstoday.org trialstoday.org/trial/NCT05753007

A Clinical Trial of a Hemp-Derived, High Cannabidiol ... This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full- ...

5. nature.com nature.com/articles/s44276-024-00088-0

Cannabidiol and fluorinated derivative anti-cancer ... CBD has also been shown to be effective in in vivo GBM models U87, U251, GSC3832 and GSC387 at 15–20 mg/Kg, in combination treatments with THC ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8962767/

Cannabidiol Μay Prolong Survival in Patients With ... In conclusion, concomitant CBD seems to prolong the survival of patients with glioblastoma multiforme; CBD was well supported and did not cause ...

7. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05477-0

From bench to bedside: the application of cannabidiol in glioma CBD inhibits the migration, invasion, and angiogenesis of glioma cells. Gliomas, particularly GBM, pose a grave threat to patient survival.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024013512

Cannabis and Craniotomy for Glioblastoma The use of cannabis seems to be promising for patients with high-grade malignant brain tumors; however, it is not a risk-free undertaking nor a panacea. Hence, ...