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

May 5, 2022 updated by: Phuong T Ngo, University of Louisville

Beta-glucan's Immuno-modulatory Effect on 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Trials Office, Brown Cancer Center
  • Phone Number: (502) 562-3429
  • Email: ctobcc@louisville.edu

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • James Graham Brown Cancer Center
        • Principal Investigator:
          • Goetz H Kloecker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIM 2: subjects with suspected or definitive NSCLC diagnosis
1 (one) 250mg beta-glucan capsule 3 times a day for 14 days
Dietary supplement: 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
Other Names:
  • Imucell WGP
Experimental: AIM 3: subjects with resectable NSCLC
1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days
Dietary supplement: 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
Other Names:
  • Imucell WGP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-treatment and post-treatment
resected lung tissue will be tested to determine macrophage phenotype
Time Frame: post-treatment
AIM 3 only
post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Goetz H Kloecker, MD, James Graham Brown Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2029

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.0041
  • BCC-LUN-07-005 (Other Identifier: James Graham Brown Cancer Center Clinical Trials Office)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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