Non Small Cell Lung CancerNCT00682032
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
A study testing beta-glucan in people with Non Small Cell Lung Cancer, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- beta-glucan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Goetz H Kloecker, MD
About this study
Official title: Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.
Read the 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 by the U.S. Food and Drug Administration (FDA). Studies in animals have shown that Imucell WGP helps trigger white blood cells to destroy cancer cells. Other animal studies combining Imucell WGP with anti-cancer medications have shown greater tumor regression and tumor-free survival.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- beta-glucan
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-glucanDietary supplement
Also called Imucell WGP
AIM 2: regimen to begin after baseline blood draw; AIM 3: regimen to begin after baseline blood draw and to be completed prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| AIM 2: subjects with suspected or definitive NSCLC diagnosis | Experimental | 1 (one) 250mg beta-glucan capsule 3 times a day for 14 days Receives: Dietary Supplement: beta-glucan |
| AIM 3: subjects with resectable NSCLC | Experimental | 1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days Receives: Dietary Supplement: beta-glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils complement receptor 3 (CR3) and test the cytotoxicity of the primed neutrophils.
compare CR3 CBRM1/5 expression, CR3-dependent cellular cytotoxicity, myeloid-derived suppressor cells (MDSC) frequency, and T-cell function (cytokine secretion) before and after beta-glucan uptake
Measured: pre-treatment and post-treatment
resected lung tissue will be tested to determine macrophage phenotype
AIM 3 only
Measured: post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2025 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Phuong T Ngo, University of Louisville
- Investigators
- Goetz H Kloecker, MD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682032
- Sponsor's protocol ID
- 08.0041
- Other IDs
- BCC-LUN-07-005
- Status last verified
- Jan 2025
- First submitted
- 19 May 2008
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00682032
- Acronym / sponsor ID
- 08.0041
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Oct 2008
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 by the U.S. Food and Drug Administration (FDA). Studies in animals have shown that Imucell WGP helps trigger white blood cells to destroy cancer cells. Other animal studies combining Imucell WGP with anti-cancer medications have shown greater tumor regression and tumor-free survival.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIM 2: subjects with suspected or definitive NSCLC diagnosis | Experimental | Dietary Supplement: beta-glucan1 (one) 250mg beta-glucan capsule 3 times a day for 14 days |
| AIM 3: subjects with resectable NSCLC | Experimental | Dietary Supplement: beta-glucan1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- history of hypersensitivity reactions attributed to beta-glucan
- currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beta-glucanAlso: Imucell WGPAIM 2: regimen to begin after baseline blood draw; AIM 3: regimen to begin after baseline blood draw and to be completed prior to surgery | Dietary supplement | AIM 2: subjects with suspected or definitive NSCLC diagnosis, AIM 3: subjects with resectable NSCLC |
Primary outcome
blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils complement receptor 3 (CR3) and test the cytotoxicity of the primed neutrophils.
Time frame: pre-treatment and post-treatment
compare CR3 CBRM1/5 expression, CR3-dependent cellular cytotoxicity, myeloid-derived suppressor cells (MDSC) frequency, and T-cell function (cytokine secretion) before and after beta-glucan uptake
resected lung tissue will be tested to determine macrophage phenotype
Time frame: post-treatment
AIM 3 only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Goetz H Kloecker, MD principal investigator
James Graham Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta-glucan in people with Non Small Cell Lung Cancer, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Office, Brown Cancer Center ((502) 562-3429, ctobcc@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils complement receptor 3 (CR3) and test the cytotoxicity of the primed neutrophils. (time frame: pre-treatment and post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.