Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT00682032
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047071', 'term': 'beta-Glucans'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'pre-treatment and post-treatment', 'description': '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'}, {'measure': 'resected lung tissue will be tested to determine macrophage phenotype', 'timeFrame': 'post-treatment', 'description': 'AIM 3 only'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'AIM 2:\n\nInclusion Criteria:\n\n* suspected or definitive diagnosis of non-small cell lung cancer (NSCLC)\n* treatment naive or no treatment within 6 months prior to enrollment\n* able to swallow pills\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3\n* absolute neutrophil count (ANC) at least 1500/microl\n* able to understand and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* history of hypersensitivity reactions attributed to beta-glucan\n* currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy\n* 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\n\nAIM 3:\n\nInclusion Criteria:\n\n* resectable non-small cell lung cancer (NSCLC), as determined by a thoracic surgeon\n* treatment naive\n* able to swallow pills\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* must be an operative candidate\n* absolute neutrophil count (ANC) at least 1500/microl\n* able to understand and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* history of hypersensitivity reactions attributed to beta-glucan\n* currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy\n* 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'}, 'identificationModule': {'nctId': 'NCT00682032', 'briefTitle': 'The Effect of Beta-glucan in Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': "Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer", 'orgStudyIdInfo': {'id': '08.0041'}, 'secondaryIdInfos': [{'id': 'BCC-LUN-07-005', 'type': 'OTHER', 'domain': 'James Graham Brown Cancer Center Clinical Trials Office'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIM 2: subjects with suspected or definitive NSCLC diagnosis', 'description': '1 (one) 250mg beta-glucan capsule 3 times a day for 14 days', 'interventionNames': ['Dietary Supplement: beta-glucan']}, {'type': 'EXPERIMENTAL', 'label': 'AIM 3: subjects with resectable NSCLC', 'description': '1 (one) 250mg beta-glucan capsule 3 times a day for 10 to 20 days', 'interventionNames': ['Dietary Supplement: beta-glucan']}], 'interventions': [{'name': 'beta-glucan', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Imucell WGP'], 'description': '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', 'armGroupLabels': ['AIM 2: subjects with suspected or definitive NSCLC diagnosis', 'AIM 3: subjects with resectable NSCLC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Goetz H Kloecker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'centralContacts': [{'name': 'Clinical Trials Office, Brown Cancer Center', 'role': 'CONTACT', 'email': 'ctobcc@louisville.edu', 'phone': '(502) 562-3429'}], 'overallOfficials': [{'name': 'Goetz H Kloecker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James Graham Brown Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'James Graham Brown Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, M.D.', 'investigatorFullName': 'Phuong T Ngo', 'investigatorAffiliation': 'University of Louisville'}}}}