Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Louisville
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
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.
Time Frame: pre-treatment and post-treatment
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
resected lung tissue will be tested to determine macrophage phenotype
Time Frame: post-treatment
AIM 3 only
Secondary Outcomes
No secondary outcomes reported
Investigators
Phuong T Ngo
Assistant Professor, M.D.
University of Louisville