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Dietary Supplement
Beta-glucan for Lung Cancer
N/A
Recruiting
Led By Goetz H Kloecker, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Suspected or definitive diagnosis of non-small cell lung cancer (NSCLC)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment
Awards & highlights
Study Summary
This trial will study how well beta-glucan works in boosting the immune system of people with non-small cell lung cancer.
Who is the study for?
This trial is for adults who can swallow pills, have a certain level of physical fitness (ECOG 0-3), and enough white blood cells (ANC at least 1500/microl). They must be able to consent, have operable non-small cell lung cancer, and not received treatment in the last 6 months. It's not for those allergic to beta-glucan or on steroids/immunosuppressants, or with uncontrolled illnesses or psychiatric conditions.Check my eligibility
What is being tested?
The study is testing how beta-glucan affects the immune system in patients with non-small cell lung cancer. Participants will take beta-glucan orally to see if it helps their body fight cancer.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to immune system changes due to beta-glucan. Patients with previous hypersensitivity reactions to beta-glucan are excluded from the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with non-small cell lung cancer.
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I can care for myself but may not be able to do heavy physical work.
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My lung cancer can be removed with surgery, as confirmed by a thoracic surgeon.
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I am fit for surgery.
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I can swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment and post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment and post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
resected lung tissue will be tested to determine macrophage phenotype
Trial Design
2Treatment groups
Experimental Treatment
Group I: AIM 3: subjects with resectable NSCLCExperimental Treatment1 Intervention
1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days
Group II: AIM 2: subjects with suspected or definitive NSCLC diagnosisExperimental Treatment1 Intervention
1 (one) 250mg beta-glucan capsule 3 times a day for 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
beta-glucan
2005
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,684 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
8,918 Total Patients Enrolled
Goetz H Kloecker, MDPrincipal InvestigatorJames Graham Brown Cancer Center
5 Previous Clinical Trials
103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with non-small cell lung cancer.I can care for myself but may not be able to do heavy physical work.I am currently on continuous corticosteroids or other immunosuppressive drugs.Your absolute neutrophil count needs to be at least 1500 per microliter.My lung cancer can be removed with surgery, as confirmed by a thoracic surgeon.I am fit for surgery.I do not have any severe illnesses that could interfere with the study.I can swallow pills.You have had allergic reactions to beta-glucan in the past.I haven't received any treatment for my condition in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: AIM 2: subjects with suspected or definitive NSCLC diagnosis
- Group 2: AIM 3: subjects with resectable NSCLC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are in this clinical trial?
"Affirmative. Clinicaltrials.gov attests to the ongoing recruitment for this trial, which was first posted on October 1st 2008 and last updated on May 5th 2022. 300 participants are needed from one site location."
Answered by AI
Has recruitment for this experiment commenced?
"Affirmative. Clinicaltrials.gov exhibits that this medical experiment, which first appeared on October 1st 2008 is currently recruiting volunteers. 300 individuals are needed to be enrolled at a single site."
Answered by AI
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