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NCT00682032NARecruiting

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

University of Louisville

Start Date

10/1/2008

Completion Date

3/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIETARY_SUPPLEMENT

beta-glucan

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Conditions

Non Small Cell Lung Cancer

Locations

James Graham Brown Cancer Center

Louisville, Kentucky 40202

United States