The Effect of Beta-glucan in Non-Small Cell Lung Cancer

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

Detailed Description
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Beta-glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. Imucell WGP is extracted from food-grade baker's yeast, which is permitted for use in food by the U.S. Food and Drug Administration (FDA). Studies in animals have shown that Imucell WGP helps trigger white blood cells to destroy cancer cells. Other animal studies combining Imucell WGP with anti-cancer medications have shown greater tumor regression and tumor-free survival.

Official Title
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Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Dietary Supplement: beta-glucan


Participation Criteria
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Eligibility Criteria
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AIM 2: Inclusion Criteria: suspected or definitive diagnosis of non-small cell lung cancer (NSCLC) treatment naive or no treatment within 6 months prior to enrollment able to swallow pills Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 absolute neutrophil count (ANC) at least 1500/microl able to understand and willing to sign a written informed consent document Exclusion Criteria: history of hypersensitivity reactions attributed to beta-glucan currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy presence of an uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements AIM 3: Inclusion Criteria: resectable non-small cell lung cancer (NSCLC), as determined by a thoracic surgeon treatment naive able to swallow pills Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 must be an operative candidate absolute neutrophil count (ANC) at least 1500/microl able to understand and willing to sign a written informed consent document Exclusion Criteria: history of hypersensitivity reactions attributed to beta-glucan currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy presence of an uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIM 2: subjects with suspected or definitive NSCLC diagnosis<br>1 (one) 250mg beta-glucan capsule 3 times a day for 14 days | Dietary Supplement: beta-glucan<br>* AIM 2: regimen to begin after baseline blood draw; AIM 3: regimen to begin after baseline blood draw and to be completed prior to surgery<br>* Other names: Imucell WGP;|
| Experimental: AIM 3: subjects with resectable NSCLC<br>1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days | Dietary Supplement: beta-glucan<br>* AIM 2: regimen to begin after baseline blood draw; AIM 3: regimen to begin after baseline blood draw and to be completed prior to surgery<br>* Other names: Imucell WGP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils complement receptor 3 (CR3) and test the cytotoxicity of the primed neutrophils. | compare CR3 CBRM1/5 expression, CR3-dependent cellular cytotoxicity, myeloid-derived suppressor cells (MDSC) frequency, and T-cell function (cytokine secretion) before and after beta-glucan uptake | pre-treatment and post-treatment | 
| resected lung tissue will be tested to determine macrophage phenotype | AIM 3 only | post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC