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



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2008
End Date:March 2029
Contact:Clinical Trials Office, Brown Cancer Center
Email:ctobcc@louisville.edu
Phone:(502) 562-3429

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

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

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.

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
We found this trial at
1
site
529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
Principal Investigator: Goetz H Kloecker, MD
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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