Effect of beta-glucan on immune response in lung cancer patients
Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer
NA · University of Louisville · NCT00682032
This study tests if a dietary supplement called beta-glucan can help boost the immune system in people with non-small cell lung cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville (other) |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT00682032 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of beta-glucan, a dietary supplement derived from baker's yeast, on the immune system of patients diagnosed with non-small cell lung cancer (NSCLC). The research aims to determine whether beta-glucan can enhance the body's ability to fight cancer by stimulating white blood cells. Participants will include treatment-naive individuals with a confirmed diagnosis of NSCLC, and the study will assess the safety and efficacy of beta-glucan in this context.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of non-small cell lung cancer who have not received treatment within the last six months.
Not a fit: Patients currently undergoing immunosuppressive therapy or with uncontrolled intercurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-invasive treatment option that enhances immune response in lung cancer patients.
How similar studies have performed: Previous studies have shown promising results with beta-glucan in animal models, but this approach in humans is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- James Graham Brown Cancer Center — Louisville, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Goetz H Kloecker, MD — James Graham Brown Cancer Center
- Study coordinator: Clinical Trials Office, Brown Cancer Center
- Email: ctobcc@louisville.edu
- Phone: (502) 562-3429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non Small Cell Lung Cancer, NSCLC