NCT00682032 · University of Louisville
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
What this study is about
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.
View original scientific description
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Louisville, Kentucky
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 10, 2025 · Source of record for eligibility and locations