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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00682032
• Other study ID #: 08.0041
• Secondary ID: BCC-LUN-07-005
• Status: Recruiting
• Phase: N/A
• Start date: October 2008
• Est. completion date: March 2029

Study information

• Verified date: May 2022
• Source: University of Louisville
• Contact: Clinical Trials Office, Brown Cancer Center
• Phone: (502) 562-3429
• Email: ctobcc[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2029
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Dietary Supplement:
• beta-glucan
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

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	resected lung tissue will be tested to determine macrophage phenotype	AIM 3 only	post-treatment

External Links

•   Search for clinical trials at the James Graham Brown Cancer Center