Beta-Glucan for Melanoma

Overseen By Matthew Woeste, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kelly McMasters

Must be taking: Pembrolizumab

Must not be taking: Immunosuppressive therapy

Disqualifiers: Autoimmune diseases, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether taking beta-glucan by mouth can help boost the immune system in patients with advanced melanoma who are already receiving Pembrolizumab. The goal is to see if this combination can make the immune system more effective at preventing cancer from coming back. Researchers will look at how well the immune system works and track patient outcomes like cancer recurrence and survival. Recent studies showed promising results about the combination of β-glucans and immune checkpoint inhibitors for patients affected by different solid tumors.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are on ongoing immunosuppressive therapy.

Is beta-glucan safe for human use?

Beta-glucans are generally considered safe and have been used in various clinical studies for their immune-boosting and other health benefits. Studies in animals, such as rats, have shown no significant toxicity even at high doses, and they have been used safely in humans for conditions like cancer and metabolic disorders. ^{1 2 3 4 5}

How does the beta-glucan treatment for melanoma differ from other treatments?

Beta-glucan is unique because it is a natural compound that boosts the immune system, particularly by activating natural killer (NK) cells, which helps fight melanoma. Unlike traditional chemotherapy, beta-glucan can be taken orally and enhances the effects of other cancer treatments, making it a promising complementary therapy. ^{1 5 6 7 8}

What evidence supports the effectiveness of the treatment Beta-Glucan for melanoma?

Research shows that β-glucan, a natural compound, can help reduce tumor size and improve survival rates in melanoma by boosting the immune system, particularly through the action of natural killer cells. Additionally, β-glucans have been shown to enhance the effects of chemotherapy and reshape immune cells to better fight cancer. ^{1 4 5 6 9}

Who Is on the Research Team?

Kelly M McMasters, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults with Stage III-IV melanoma who are starting or have been on Pembrolizumab therapy. They should not currently have the disease, be new to treatment or haven't had it in over 6 months, and must be able to swallow pills. People with a history of beta-glucan sensitivity, other cancers, immune suppression therapy, serious illnesses like heart failure or infections, or certain mental health issues can't join.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

I can swallow pills.

I haven't had any treatments, or it's been over 6 months since my last treatment.

Exclusion Criteria

I am currently on continuous immunosuppressive medication.

I have been diagnosed with mucosal melanoma.

I do not have any severe illnesses that could interfere with the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pembrolizumab for 21 days followed by beta-glucan for 21 days

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Beta-Glucan

Trial Overview The study is testing how Beta-Glucan affects the immune response in patients taking Pembrolizumab for advanced melanoma. It aims to see if this combination improves outcomes compared to what's expected from Pembrolizumab alone.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan. Pembrolizumab: 200 mg/100mL IV in three week intervals Beta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days

Who Is Running the Clinical Trial?

Kelly McMasters

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Insoluble yeast-derived β-glucan significantly reduced tumor weight and lung colonies in melanoma models, leading to improved overall survival rates in tested animals.

The study suggests that β-glucan enhances the effects of standard chemotherapy and protects blood cells, with some of its benefits linked to its direct action on natural killer (NK) cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucan Supplementation Has Strong Anti-melanoma Effects: Role of NK Cells. Vetvicka, V., Vetvickova, J.[2015]

Certain β-glucans, specifically curdlan, yeast-b, and zymosan, can re-polarize immune-suppressive macrophages into a more active M1-like phenotype, enhancing their ability to produce immune signals and recruit other immune cells.

These β-glucans promote the secretion of chemo-attractants that help in drawing monocytes and neutrophils to the tumor site, potentially improving anti-cancer T-cell responses in the immune-suppressive tumor microenvironment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curdlan, zymosan and a yeast-derived β-glucan reshape tumor-associated macrophages into producers of inflammatory chemo-attractants. de Graaff, P., Berrevoets, C., Rӧsch, C., et al.[2023]

β-glucans, found in foods like mushrooms, have shown potential therapeutic effects for various conditions, including metabolic syndrome, obesity, and immune-mediated diseases, due to their ability to modulate metabolism and the gut microbiome.

Despite their promising applications, significant challenges remain in understanding the diverse mechanisms of action and the variability in effects of different β-glucan preparations, which complicates their clinical testing and therapeutic translation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application. Murphy, EJ., Rezoagli, E., Major, I., et al.[2020]

β-glucans, found in mushrooms and cereals, have shown promising anticancer properties primarily through their ability to stimulate the immune system, as evidenced by various in vitro and in vivo studies, although human studies are limited.

Clinical trials, particularly in the Far East, suggest that mushroom-derived β-glucans can improve patient survival and quality of life when used as adjuvant therapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

β-Glucans and their applications in cancer therapy: focus on human studies. Aleem, E.[2019]

β-glucans are safe and functional polysaccharides that can enhance the immune response against tumors by activating innate immune cells, making them a promising immunostimulant in cancer treatment.

Clinical studies have shown that soluble β-glucans can effectively bind to immune cell receptors, leading to pro-inflammatory responses that bolster the body's antitumor defenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor effect of soluble β-glucan as an immune stimulant. Wu, L., Zhao, J., Zhang, X., et al.[2021]

Different types of beta-glucans, derived from sources like fungi, yeast, and algae, have varying effects on immune cell activation, with particulate forms showing stronger stimulation of immune responses compared to soluble forms.

The study found that certain beta-glucans, particularly Curdlan from bacteria and Zymosan from yeast, significantly enhanced lymphocyte proliferation and cytokine production, indicating their potential as immunomodulators in enhancing innate immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of beta-glucans on porcine leukocytes. Sonck, E., Stuyven, E., Goddeeris, B., et al.[2022]

A study on Wistar rats showed that consuming beta-glucan-enriched soluble fiber from barley at concentrations up to 7% for 28 days did not result in any adverse health effects, indicating its safety for consumption.

The only notable finding was a non-dose-dependent increase in circulating lymphocytes in male rats, which was not observed in females and did not indicate toxicity, suggesting that beta-glucan is safe even at high dietary levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the toxicity of concentrated barley beta-glucan in a 28-day feeding study in Wistar rats. Delaney, B., Carlson, T., Frazer, S., et al.[2019]

Purified β-glucan from barley was found to cause a temporary halt in the proliferation of human dermal fibroblasts, which was linked to the Retinoblastoma protein, indicating a specific mechanism of action.

In addition to affecting cell growth, barley β-glucan enhanced the migration of fibroblasts and improved wound healing in mouse skin, suggesting its potential as a therapeutic agent for promoting tissue repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barley β-glucan accelerates wound healing by favoring migration versus proliferation of human dermal fibroblasts. Fusté, NP., Guasch, M., Guillen, P., et al.[2019]

Oral administration of (1-->3)-beta-D-glucan significantly enhances the anti-tumor effects of monoclonal antibodies in various human tumor models, indicating its potential as a powerful adjunct therapy.

The effectiveness of beta-glucan in boosting anti-tumor responses was consistent across different tumor types and antigens, suggesting a broad applicability in cancer treatment, with a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orally administered beta-glucans enhance anti-tumor effects of monoclonal antibodies. Cheung, NK., Modak, S., Vickers, A., et al.[2020]

Citations

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

Glucan Supplementation Has Strong Anti-melanoma Effects: Role of NK Cells. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Curdlan, zymosan and a yeast-derived β-glucan reshape tumor-associated macrophages into producers of inflammatory chemo-attractants. [2023]

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

β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

β-Glucans and their applications in cancer therapy: focus on human studies. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Antitumor effect of soluble β-glucan as an immune stimulant. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of beta-glucans on porcine leukocytes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of the toxicity of concentrated barley beta-glucan in a 28-day feeding study in Wistar rats. [2019]

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

Barley β-glucan accelerates wound healing by favoring migration versus proliferation of human dermal fibroblasts. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Orally administered beta-glucans enhance anti-tumor effects of monoclonal antibodies. [2020]