Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC
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.
Interventions
DIETARY_SUPPLEMENTbeta-glucan
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
Sponsors
James Graham Brown Cancer Center
University of Louisville
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| resected lung tissue will be tested to determine macrophage phenotype | post-treatment | AIM 3 only |
| 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. | 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 |
Countries
United States
Contacts
Primary ContactClinical Trials Office, Brown Cancer Center
Outcome results
None listed