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

This study is currently recruiting participants.
Verified April 2013 by James Graham Brown Cancer Center
Sponsor:
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00682032
First received: May 19, 2008
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Beta-glucan's Effect on Cetuximab Induced Cytotoxicity in Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 CR3 and test the cytotoxicity of the primed neutrophils. [ Time Frame: pre-treatment and post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beta-glucan, single arm
250mg beta-glucan capsule prior to surgery
 Dietary Supplement: beta-glucan
1 (one) 250mg beta-glucan capsule, 3 times a day, for 21 days
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

Inclusion Criteria:

  • suspected or definitive diagnosis of non-small cell lung cancer (NSCLC)
  • must be treatment naive
  • ability to swallow pills
  • ECOG performance status of 0 to 3
  • absolute neutrophil count (ANC) greater than or equal to 1500/microl
  • ability to understand and willingness 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
Investigators
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center
  More 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: April 22, 2013
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 May 19, 2013