The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Dietary Supplement: beta-glucan
- Registration Number
- NCT00682032
- Lead Sponsor
- University of Louisville
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AIM 3: subjects with resectable NSCLC beta-glucan 1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days AIM 2: subjects with suspected or definitive NSCLC diagnosis beta-glucan 1 (one) 250mg beta-glucan capsule 3 times a day for 14 days
- Primary Outcome Measures
Name Time Method 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. pre-treatment and post-treatment 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
resected lung tissue will be tested to determine macrophage phenotype post-treatment AIM 3 only
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States