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NCT Number: NCT00682032

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Goetz H Kloecker, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

beta-glucan

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

Other names: Imucell WGP

Primary outcomes

  1. 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.

    Time frame: 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

  2. resected lung tissue will be tested to determine macrophage phenotype

    Time frame: post-treatment

    AIM 3 only

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Office, Brown Cancer Center

CONTACT

[email protected]

(502) 562-3429

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • James Graham Brown Cancer Center

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2025
Study completion
2029
First posted
May 21, 2008
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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