RecruitingInterventional

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

NCT ID: NCT00682032Sponsor: University of LouisvilleLast updated: 2025-01-10

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.

Arms & 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

Outcome measures

Primary

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
Time frame: pre-treatment and post-treatment
resected lung tissue will be tested to determine macrophage phenotype
AIM 3 only
Time frame: post-treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202

Recruiting

Goetz H Kloecker, MD · Principal Investigator