Clinical trial NCT00682032: The Effect of Beta-glucan in Non-Small Cell Lung Cancer
Official title: Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2008-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: pre-treatment and post-treatment
measure: resected lung tissue will be tested to determine macrophage phenotype
timeFrame: post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Goetz H Kloecker, MD
role: PRINCIPAL_INVESTIGATOR
References: