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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, 2022
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Phuong T Ngo, University of Louisville

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Dietary Supplement: beta-glucan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer
Study Start Date : October 2008
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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 Name: 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 Name: Imucell WGP


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682032


Contacts
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Contact: Clinical Trials Office, Brown Cancer Center (502) 562-3429 ctobcc@louisville.edu

Locations
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United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Goetz H Kloecker, MD         
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
Investigators
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Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center
More Information
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Additional Information:

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Responsible Party: Phuong T Ngo, Assistant Professor, M.D., University of Louisville
ClinicalTrials.gov Identifier: NCT00682032    
Other Study ID Numbers: 08.0041
BCC-LUN-07-005 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Keywords provided by Phuong T Ngo, University of Louisville:
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms