NCT00682032

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2008Mar 2029

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

16.5 years

First QC Date

May 19, 2008

Last Update Submit

January 9, 2025

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (2)

  • 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

    pre-treatment and post-treatment

  • resected lung tissue will be tested to determine macrophage phenotype

    AIM 3 only

    post-treatment

Study Arms (2)

AIM 2: subjects with suspected or definitive NSCLC diagnosis

EXPERIMENTAL

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

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

Dietary Supplement: beta-glucan

Interventions

beta-glucanDIETARY_SUPPLEMENT

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

Also known as: Imucell WGP
AIM 2: subjects with suspected or definitive NSCLC diagnosisAIM 3: subjects with resectable NSCLC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydrates

Study Officials

  • Goetz H Kloecker, MD

    James Graham Brown Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Office, Brown Cancer Center

CONTACT

(502) 562-3429ctobcc@louisville.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, M.D.

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2025

Study Completion (Estimated)

March 1, 2029

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations

US(1)