Louisville, Kentucky 40202


Purpose:

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


Study summary:

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.


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 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


NCT ID:

NCT00682032


Primary Contact:

Principal Investigator
Goetz H Kloecker, MD
James Graham Brown Cancer Center

Clinical Trials Office, Brown Cancer Center
Phone: (502) 562-3429
Email: ctobcc@louisville.edu


Backup Contact:

N/A


Location Contact:

Louisville, Kentucky 40202
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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