Status:
RECRUITING
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
James Graham Brown Cancer Center
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- AIM 2:
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00682032
Start Date
October 1 2008
End Date
March 1 2029
Last Update
January 10 2025
Active Locations (1)
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1
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202