Clinical Trials /

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

NCT00682032

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT00682032

Trial Eligibility

Document

Title

  • Brief Title: The Effect of Beta-glucan in Non-Small Cell Lung Cancer
  • Official Title: Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 08.0041
  • SECONDARY ID: BCC-LUN-07-005
  • NCT ID: NCT00682032

Conditions

  • Non Small Cell Lung Cancer

Purpose

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

Detailed 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.

Trial Arms

NameTypeDescriptionInterventions
AIM 2: subjects with suspected or definitive NSCLC diagnosisExperimental1 (one) 250mg beta-glucan capsule 3 times a day for 14 days
    AIM 3: subjects with resectable NSCLCExperimental1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days

      Eligibility 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
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure: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
      Safety Issue:
      Description: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

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:University of Louisville

      Trial Keywords

      • NSCLC

      Last Updated

      May 6, 2021