The Effect of Beta-glucan in Non-Small Cell Lung Cancer
Recruiting · NCT00682032 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Louisville
View the official record on ClinicalTrials.gov →Interventions studied
beta-glucan
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- James Graham Brown Cancer Center - Louisville, Kentucky, United States