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

This study is currently recruiting participants.
Verified February 2014 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00682032
First received: May 19, 2008
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Non Small Cell Lung Cancer
Dietary Supplement: beta-glucan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    AIM 3 only


Estimated Enrollment: 300
Study Start Date: April 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682032

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

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

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00682032     History of Changes
Other Study ID Numbers: 08.0041, BCC-LUN-07-005
Study First Received: May 19, 2008
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014