Recruiting

Beta-glucan

Sponsor:

University of Louisville

Code:

NCT00682032

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

beta-glucan

Study Details

Brief summary:

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT00682032

Start date

Oct, 2008

Status verified date

Jan, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: AIM 2: subjects with suspected or definitive NSCLC diagnosis

1 (one) 250mg beta-glucan capsule 3 times a day for 14 days

experimental: AIM 3: subjects with resectable NSCLC

1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days

Interventions

beta-glucan

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

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 ]
  • resected lung tissue will be tested to determine macrophage phenotype [ Time Frame: post-treatment ]

Central Contacts and Locations

Central contacts

Clinical Trials Office, Brown Cancer Center

(502) 562-3429ctobcc@louisville.edu

Locations

James Graham Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Goetz H Kloecker, MD

More Information

Sponsor

University of Louisville

Last update posted

Jan 10, 2025

Last verified

Jan, 2025

Keywords

  • NSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-01-10.