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

Last updated: January 9, 2025
Sponsor: University of Louisville
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

beta-glucan

Clinical Study ID

NCT00682032
08.0041
BCC-LUN-07-005
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • history of hypersensitivity reactions attributed to beta-glucan

  • currently receiving continuous corticosteroids or other ongoing immunosuppressivetherapy

  • presence of an uncontrolled intercurrent illness including but not limited to:ongoing or active infection, symptomatic congestive heart failure, unstable anginapectoris, cardiac arrhythmia, or psychiatric illness/social situations that wouldlimit 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 immunosuppressivetherapy

  • presence of an uncontrolled intercurrent illness including but not limited to:ongoing or active infection, symptomatic congestive heart failure, unstable anginapectoris, cardiac arrhythmia, or psychiatric illness/social situations that wouldlimit compliance with study requirements

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: beta-glucan
Phase:
Study Start date:
October 01, 2008
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • James Graham Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

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