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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how beta-glucan, a natural substance in foods like oats and mushrooms, affects the immune system of people with non-small cell lung cancer (NSCLC). The researchers aim to determine if beta-glucan can enhance cancer care by boosting the body's defenses. The study includes two groups: one for individuals with a suspected or confirmed NSCLC diagnosis and another for those whose NSCLC can be surgically removed. Ideal candidates are those with NSCLC who haven't received recent treatment and are open to trying new options. As an unphased trial, this study provides patients the chance to explore innovative treatments that could improve their cancer care.

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.

Is there any evidence suggesting that beta-glucan is likely to be safe for humans?

Research has shown that beta-glucan is generally safe for use. Studies have found that cancer patients undergoing chemotherapy tolerate beta-glucan well, suggesting it might boost the immune system without major side effects.

Additionally, when combined with other lung cancer treatments, beta-glucan has proven safe and effective. Other research indicates that oral yeast beta-glucans are safe and help strengthen the immune system.

Overall, beta-glucan appears well-tolerated, with no significant negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Beta-glucan is unique because it harnesses a natural compound found in yeast, mushrooms, and oats to potentially boost the immune system against lung cancer. Unlike traditional treatments for non-small cell lung cancer (NSCLC) that often involve chemotherapy, radiation, or surgery, beta-glucan offers a novel approach by targeting the body's immune response. Researchers are excited about beta-glucan's ability to enhance immune cells, which might lead to a more targeted attack on cancer cells, potentially with fewer side effects than conventional therapies.

What evidence suggests that beta-glucan might be an effective treatment for non-small cell lung cancer?

Research has shown that beta-glucan, which participants in this trial will receive, might help fight non-small cell lung cancer by strengthening the immune system. Studies have found that it can slow cancer cell growth and even cause cell death. Evidence also suggests that beta-glucan can prevent the formation of new blood vessels, which tumors need to grow. When combined with other treatments, beta-glucan has shown promise in reducing tumor size and improving survival rates in animal studies. Overall, these findings suggest that beta-glucan could support the body’s natural defenses against cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Goetz Kloecker

Principal Investigator

James Graham Brown Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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, 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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00682032

The Effect of Beta-glucan in Non-Small Cell Lung Cancer A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10776902/

Potential promising anticancer applications of β-glucans Studies have indicated that they can inhibit cancer cell growth, induce apoptosis (programmed cell death) in cancer cells, and impede the formation of new blood ...

3. trialx.com trialx.com/clinical-trials/listings/237736/the-effect-of-beta-glucan-in-non-small-cell-lung-cancer/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

The Effect of Beta-glucan in Non-Small Cell Lung Cancer Other animal studies combining Imucell WGP with anti-cancer medications have shown greater tumor regression and tumor-free survival. Eligibility.

4. bmcimmunol.biomedcentral.com bmcimmunol.biomedcentral.com/articles/10.1186/s12865-024-00651-x

β-glucan combined with Envafolimab and Endostar as ... β-glucan combined with Envafolimab and Endostar has considerable efficacy and safety for immune rechallenge in metastatic NSCLC patients who failed of anti-PD- ...

5. researchgate.net researchgate.net/publication/315214473_Lung_cancer_and_b-glucans_review_of_potential_therapeutic_applications

Lung cancer and β-glucans: review of potential therapeutic ... β-glucans, a cell wall component of certain bacteria and fungi, potentiate the immune system against microbes and toxic substances. Moreover, β- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00682032

The Effect of Beta-glucan in Non-Small Cell Lung Cancer Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7770584/

β-Glucan Metabolic and Immunomodulatory Properties and ... β-glucans decreased inflammatory cytokines TNF-α, IL-1β and IL-6, and reduced the lung injury score, in a lung injury model induced by CLP [145]. 7.3. Cancer ...

8. betaglucan.org betaglucan.org/r-z/

“R' – “Z” Research The results of all studies taken together clearly indicate that oral intake of insoluble yeast beta-glucans is safe and has an immune strengthening effect. ,,, ...