[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00682032":3,"trial-entities:NCT00682032":97,"trial-summary:NCT00682032":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":70,"locations":73,"central_contacts":87,"overall_officials":93,"references":95,"see_also_links":96},"NCT00682032","08.0041","The Effect of Beta-glucan in Non-Small Cell Lung Cancer","Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer","RECRUITING","2029-03","2025-01","2025-01-10","2008-10","University of Louisville","OTHER",true,"The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.","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.",[19],"Non Small Cell Lung Cancer",[21],"NSCLC","INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},300,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"DIETARY_SUPPLEMENT","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",[35,36],"AIM 2: subjects with suspected or definitive NSCLC diagnosis","AIM 3: subjects with resectable NSCLC",[38],"Imucell WGP",[40,44],{"measure":41,"description":42,"timeFrame":43},"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\u002F5 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",{"measure":45,"description":46,"timeFrame":47},"resected lung tissue will be tested to determine macrophage phenotype","AIM 3 only","post-treatment",[],"ALL","18 Years",null,false,{"inclusion":54,"exclusion":65,"raw_text":69},[55,56,57,58,59,60,61,62,57,63,64,59,60],"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\u002Fmicrol","able to understand and willing to sign a written informed consent document","resectable non-small cell lung cancer (NSCLC), as determined by a thoracic surgeon","treatment naive","Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2","must be an operative candidate",[66,67,68,66,67,68],"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\u002Fsocial situations that would limit compliance with study requirements","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\u002Fmicrol\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\u002Fsocial 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\u002Fmicrol\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\u002Fsocial situations that would limit compliance with study requirements",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":84},"James Graham Brown Cancer Center","Louisville","Kentucky","40202","United States",[81],{"name":82,"role":83},"Goetz H Kloecker, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},38.25424,-85.75941,[88],{"name":89,"role":90,"phone":91,"email":92},"Clinical Trials Office, Brown Cancer Center","CONTACT","(502) 562-3429","ctobcc@louisville.edu",[94],{"name":82,"affiliation":75,"role":83},[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study planning to enroll 300 participants. The phase of the study is not specified.","completed","Beta-glucan for Non-Small Cell Lung Cancer","This study is looking at how a dietary supplement called beta-glucan affects the immune system in people with non-small cell lung cancer (NSCLC). Beta-glucan is an over-the-counter supplement made from baker's yeast that may help your body's immune cells fight cancer. Researchers will take blood samples before and after treatment with beta-glucan to see if it makes certain immune cells (neutrophils) more active. If you have suspected or confirmed NSCLC, are at least 18 years old, and haven't had recent cancer treatment, you might be able to join. The study aims to enroll 300 participants, but its current status is unclear.","Blood specimens will be taken pre-treatment and post-treatment. Resected lung tissue will be tested post-treatment.",101,"You would have blood drawn before and after treatment with beta-glucan. If you have surgery, resected lung tissue will be tested after the surgery.","Not stated in the trial record.",[32],"v2"]