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| ID | Type | Description | Link |
|---|---|---|---|
| BCC-LUN-07-005 | Other Identifier | James Graham Brown Cancer Center Clinical Trials Office |
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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIM 2: subjects with suspected or definitive NSCLC diagnosis | Experimental | 1 (one) 250mg beta-glucan capsule 3 times a day for 14 days |
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| AIM 3: subjects with resectable NSCLC | Experimental | 1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta-glucan | Dietary Supplement | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | pre-treatment and post-treatment |
| resected lung tissue will be tested to determine macrophage phenotype | AIM 3 only | post-treatment |
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AIM 2:
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Exclusion Criteria:
AIM 3:
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Office, Brown Cancer Center | Contact | (502) 562-3429 | ctobcc@louisville.edu |
| Name | Affiliation | Role |
|---|---|---|
| Goetz H Kloecker, MD | James Graham Brown Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Recruiting | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |