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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AIM 2: subjects with suspected or definitive NSCLC diagnosis

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

Group Type EXPERIMENTAL

beta-glucan

Intervention Type 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

AIM 3: subjects with resectable NSCLC

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

Group Type EXPERIMENTAL

beta-glucan

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Imucell WGP

Eligibility Criteria

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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

* 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

AIM 3:

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No