Actively Recruiting
Studying Beta-glucan's Effect on the Immune System in Non-Small Cell Lung Cancer A Clinical Trial Evaluating Beta-glucan Supplementation and Immune Response
Led by University of Louisville · Updated on 2025-01-10
300
Participants Needed
1
Research Sites
1065 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
J
James Graham Brown Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how beta-glucan, a dietary supplement derived from baker's yeast, affects the immune system in people with non-small cell lung cancer (NSCLC). Beta-glucan has been shown in animal studies to help white blood cells attack cancer cells and improve tumor shrinkage and survival when combined with anti-cancer drugs. This study aims to understand its effects on human immune cells and lung cancer tissue. Participants will receive beta-glucan supplements according to specific treatment plans starting after a baseline blood draw. One regimen is completed before surgery for those with resectable tumors. The supplement is taken by swallowing pills, and the study includes groups with different treatment statuses, including treatment-naive patients. The study observes participants before and after treatment. During the study, researchers will collect blood samples to assess how beta-glucan primes certain immune cells called neutrophils and test their cancer-killing ability. Resected lung tissue from surgery will be examined to determine changes in immune cell types called macrophages. Participants' health and immune responses will be monitored, and written consent is required. The study includes adult participants and involves performance status and blood count assessments.
CONDITIONS
Official Title
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected or confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Treatment naive or no treatment within 6 months prior to enrollment (AIM 2)
- Able to swallow pills
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 (AIM 2) or 0 to 2 (AIM 3)
- Absolute neutrophil count (ANC) of at least 1500/microl
- Able to understand and willing to sign a written informed consent document
- Resectable non-small cell lung cancer as determined by a thoracic surgeon (AIM 3)
- Must be an operative candidate (AIM 3)
You will not qualify if you...
- History of hypersensitivity reactions attributed to beta-glucan
- Currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy
- Presence of uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance with study requirements
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Trial Site Locations
Total: 1 location
1
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
C
Clinical Trials Office, Brown Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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