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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00682032
Recruitment Status : Recruiting
First Posted : May 21, 2008
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Phuong T Ngo, University of Louisville

Tracking Information
First Submitted Date  ICMJE May 19, 2008
First Posted Date  ICMJE May 21, 2008
Last Update Posted Date May 6, 2021
Study Start Date  ICMJE October 2008
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
  • 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
  • resected lung tissue will be tested to determine macrophage phenotype [ Time Frame: post-treatment ]
    AIM 3 only
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils CR3 and test the cytotoxicity of the primed neutrophils. [ Time Frame: pre-treatment and post-treatment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Beta-glucan in Non-Small Cell Lung Cancer
Official Title  ICMJE Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer
Brief Summary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE 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 Name: Imucell WGP
Study Arms  ICMJE
  • Experimental: AIM 2: subjects with suspected or definitive NSCLC diagnosis
    1 (one) 250mg beta-glucan capsule 3 times a day for 14 days
    Intervention: Dietary Supplement: beta-glucan
  • Experimental: AIM 3: subjects with resectable NSCLC
    1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days
    Intervention: Dietary Supplement: beta-glucan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2014)
300
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2008)
10
Estimated Study Completion Date  ICMJE March 2029
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Office, Brown Cancer Center (502) 562-3429 ctobcc@louisville.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00682032
Other Study ID Numbers  ICMJE 08.0041
BCC-LUN-07-005 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phuong T Ngo, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE James Graham Brown Cancer Center
Investigators  ICMJE
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center
PRS Account University of Louisville
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP