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

University of Louisville (UOFL)

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Dietary Supplement: beta-glucan

Study type: Interventional

Funder types: Other

Identifiers

NCT00682032

BCC-LUN-07-005 (Other Identifier)

08.0041

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

AIM 2: subjects with suspected or definitive NSCLC diagnosis

Experimental group

Description:

1 (one) 250mg beta-glucan capsule 3 times a day for 14 days

Treatment:

Dietary Supplement: beta-glucan

AIM 3: subjects with resectable NSCLC

Experimental group

Description:

1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days

Treatment:

Dietary Supplement: beta-glucan