Beta-glucan for Lung Cancer

Overseen By Clinical Trials Office, Brown Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Infection, Heart failure, Angina, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking continuous corticosteroids or other ongoing immunosuppressive therapy. If you are on these medications, you would need to stop them to participate.

What evidence supports the effectiveness of the treatment Beta-glucan for lung cancer?

Research shows that beta-glucans, found in foods like mushrooms and oats, can boost the immune system and have been used in cancer therapy, improving survival and quality of life in some patients. They have shown promise in combination with other cancer treatments, enhancing their effectiveness by stimulating immune responses. ^{1 2 3 4 5}

Is beta-glucan safe for human use?

Beta-glucans, found in foods like mushrooms and oats, are generally safe for human use and are well tolerated. They have been used in clinical trials as part of cancer treatments and are known for their immune-boosting properties. ^{2 3 5 6 7}

How does the treatment Beta-glucan for lung cancer differ from other treatments?

Beta-glucan is unique because it works by stimulating the immune system to help fight cancer, particularly when used with anti-tumor monoclonal antibodies. This combination enhances the body's ability to target and destroy cancer cells, which is different from traditional treatments that directly attack cancer cells. ^{1 2 5 8 9}

Research Team

Goetz Kloecker

Principal Investigator

James Graham Brown Cancer Center

Eligibility Criteria

This trial is for adults who can swallow pills, have a certain level of physical fitness (ECOG 0-3), and enough white blood cells (ANC at least 1500/microl). They must be able to consent, have operable non-small cell lung cancer, and not received treatment in the last 6 months. It's not for those allergic to beta-glucan or on steroids/immunosuppressants, or with uncontrolled illnesses or psychiatric conditions.

Inclusion Criteria

I have been diagnosed with non-small cell lung cancer.

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

Your absolute neutrophil count needs to be at least 1500 per microliter.

Exclusion Criteria

I am currently on continuous corticosteroids or other immunosuppressive drugs.

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

You have had allergic reactions to beta-glucan in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 250mg beta-glucan capsule 3 times a day

2-3 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Beta-glucan

Trial Overview The study is testing how beta-glucan affects the immune system in patients with non-small cell lung cancer. Participants will take beta-glucan orally to see if it helps their body fight cancer.

Participant Groups

Group I: AIM 3: subjects with resectable NSCLC Experimental Treatment 1 Intervention

1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days

Group II: AIM 2: subjects with suspected or definitive NSCLC diagnosis Experimental Treatment 1 Intervention

1 (one) 250mg beta-glucan capsule 3 times a day for 14 days

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

James Graham Brown Cancer Center

Collaborator

Trials

44

Recruited

9,200+

Findings from Research

Beta-glucans, which are not found in mammalian cells but are recognized by the immune system, have shown promise in cancer treatment when used alongside anti-tumor monoclonal antibodies, enhancing their effectiveness.

The mechanism of action involves the activation of the complement system and the recruitment of CR3(+) neutrophils, which are crucial for the success of this combination therapy, as demonstrated in both in vitro and in vivo studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yeast-derived beta-glucan in combination with anti-tumor monoclonal antibody therapy in cancer. Liu, J., Gunn, L., Hansen, R., et al.[2019]

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, 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]

Beta-glucans, the main active component in mushrooms, have been shown to stimulate the immune system and directly kill cancer cells, making them a promising treatment for colon cancer.

Research indicates that beta-glucans can reduce the size of colon cancer tumors and enhance the effectiveness of chemotherapy when used in combination with other treatments, including innovative delivery methods using nanoparticles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of fungal β-glucans for the treatment of colon cancer. Chen, J., Zhang, XD., Jiang, Z.[2019]

Monoclonal antibodies (mAbs) have significantly advanced cancer treatment, and combining them with immune-stimulating agents like β-glucan has shown promising results in pre-clinical and early human trials.

β-Glucan enhances anti-tumor immune responses by activating complement receptor 3 (CR3), which helps promote the destruction of cancer cells, indicating its potential as a valuable addition to mAb therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumor monoclonal antibodies in conjunction with β-glucans: a novel anti-cancer immunotherapy. Xiang, D., Sharma, VR., Freter, CE., et al.[2020]

β-glucans are safe and well-tolerated polysaccharides found in various foods like mushrooms and yeast, known for their health benefits and ability to modulate immune responses.

These compounds may play a significant role in cancer prevention and treatment by enhancing the body's innate immune response, making them promising candidates as adjuvants in cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shaping the Innate Immune Response by Dietary Glucans: Any Role in the Control of Cancer? Del Cornò, M., Gessani, S., Conti, L.[2020]

Beta-glucans, found in yeast, mushrooms, oats, and barley, are known to stimulate the immune system, enhancing both humoral and cellular immunity, which helps the body fight various infections.

In addition to their immune-boosting properties, beta-glucans also have beneficial effects on cholesterol levels and blood clotting, and they show potential as anti-cancer agents, making them valuable for health promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

beta-Glucans in promoting health: prevention against mutation and cancer. Mantovani, MS., Bellini, MF., Angeli, JP., et al.[2008]

Inhalation of (1-->3)-beta-D-glucan can lead to upper respiratory symptoms and induce cytokine production in blood monocytes, indicating its potential impact on immune response.

Children may be particularly vulnerable to the effects of (1-->3)-beta-D-glucan exposure, which could alter their immune system development and defense mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(1-->3)-beta-D-glucan - relationship to indoor air-related symptoms, allergy and asthma. Rylander, R., Lin, RH.[2019]

Beta-glucan, an immuno-stimulating agent, enhances the effectiveness of anti-tumor monoclonal antibodies by activating macrophages and priming neutrophils to target and kill tumor cells, as shown in both in vitro and in vivo studies.

Pre-clinical studies indicate that combining beta-glucan with anti-tumor therapies leads to significant tumor regression and improved long-term survival, with clinical trials currently investigating this combination for metastatic colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined yeast-derived beta-glucan with anti-tumor monoclonal antibody for cancer immunotherapy. Liu, J., Gunn, L., Hansen, R., et al.[2021]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Yeast-derived beta-glucan in combination with anti-tumor monoclonal antibody therapy in cancer. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

The application of fungal β-glucans for the treatment of colon cancer. [2019]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Anti-tumor monoclonal antibodies in conjunction with β-glucans: a novel anti-cancer immunotherapy. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Shaping the Innate Immune Response by Dietary Glucans: Any Role in the Control of Cancer? [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

beta-Glucans in promoting health: prevention against mutation and cancer. [2008]

8. Ireland pubmed.ncbi.nlm.nih.gov

(1-->3)-beta-D-glucan - relationship to indoor air-related symptoms, allergy and asthma. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Combined yeast-derived beta-glucan with anti-tumor monoclonal antibody for cancer immunotherapy. [2021]