[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540947":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":51,"interventions":58,"overallOfficials":67,"centralContacts":72,"locations":82,"responsibleParty":114,"collaborators":43,"id":116,"slug":43,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":66,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":43,"enrollmentInfo":124,"targetDuration":43,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":85,"whyStopped":43,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"The Canadian College of Naturopathic Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in absolute neutrophil count","The investigators will assess within-person changes in blood neutrophils throughout the study. Normal limit is 2.00 - 7.50 x 10\\^9\u002FL, where a higher neutrophil count will be considered an improvement. Values above the normal limit will be excluded due to the potential of infection.","Baseline, week 4, week 8, week 12, week 16",[14,17,20,23,26,29,32,36,40],{"measure":15,"description":16,"timeFrame":12},"Incidence of febrile neutropenia","Febrile neutropenia is defined as absolute neutrophil count \\\u003C 1.0 x 10\\^9\u002FL and temperature \\> 38.3 degrees Celsius.",{"measure":18,"description":19,"timeFrame":12},"Change in neutrophil to lymphocyte ratio (NLR)","Higher NLRs have been associated with poorer cancer prognosis. The investigators will assess within-person changes in NLR where a lower value in considered favourable. Values of neutrophils or lymphocytes outside the normal limit will be excluded due to the potential for infection.",{"measure":21,"description":22,"timeFrame":12},"Change in platelet to lymphocyte ratio (PLR)","Higher PLRs have been associated with poorer cancer prognosis. The investigators will assess within-person changes in PLR where a lower value in considered favourable. Values of lymphocytes outside the normal limit will be excluded due to the potential for infection.",{"measure":24,"description":25,"timeFrame":12},"Change in high-sensitivity C-reactive protein (CRP)","CRP is a measure of inflammation. Higher levels of inflammation have been linked with poorer cancer prognosis. The investigators will assess within-person changes in CRP as a measure of systemic inflammation. Values less than 10 mg\u002FmL are considered normal, with lower values being favourable.",{"measure":27,"description":28,"timeFrame":12},"Changes in Quality of Life","QOL will be evaluated using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C30 (EORTC QLQ C30), version 3.0, a validated tool for analyzing health-related QOL in patients with cancer participating in clinical trials. The questionnaire incorporates five functional scales, (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a global health status, and a number of single items assessing additional symptoms. Scores range from 0-100 for each item. For functional scales and global health status, a higher score is favourable. For all symptom scales, a lower score is favourable.",{"measure":30,"description":31,"timeFrame":12},"Changes in hemoglobin A1c (HbA1c)","HbA1c is a measure of blood glucose management, an item which is thought to be modulated by Maitake. The investigators will evaluate within-person changes in this metric as a measure of safety. Values below 5.7% are considered normal, with lower values being favourable.",{"measure":33,"description":34,"timeFrame":35},"Incidence of adverse events","The investigators will collect any adverse events experienced by participants per the common terminology criteria for adverse events (CTCAE) version 5.0.","16 weeks",{"measure":37,"description":38,"timeFrame":39},"Incidence of dose reductions or delays in systemic therapy","The investigators will assess the frequency of dose delays or reductions in chemotherapy or CD4\u002F6 inhibitors during the 16-week study period. Dose reductions or delays in treatment can negatively impact outcomes; not having reductions or delays is favourable.","16 weeks.",{"measure":41,"description":42,"timeFrame":35},"Addition of new medications to combat neutropenia","The investigators will assess the incidence of participants requiring new medications (e.g., granulocyte colony-stimulating factor) prescribed to combat neutropenia throughout the 16-week study period. The addition of new medications can cause adverse effects and potentially delay other conventional treatments. The absence of additional medication is considered favourable.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"NA","SINGLE_GROUP","Uncontrolled single arm clinical trial","TREATMENT",{"masking":50,"maskingDescription":43,"whoMasked":43},"NONE",[52],{"label":53,"type":54,"description":55,"interventionNames":56},"Treatment","EXPERIMENTAL","Maitake given alongside systemic chemotherapy and\u002For CD4\u002F6 inhibitors",[57],"Dietary Supplement: Black Maitake Prothera",[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DIETARY_SUPPLEMENT","Black Maitake Prothera","Mushroom extract; liquid",[53],[65,66],"Grifola Fondosa","Maitake",[68],{"name":69,"affiliation":70,"role":71},"Adrienne Junek, MD","Centre for Health Innovation","PRINCIPAL_INVESTIGATOR",[73,79],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},"Mark Legacy","CONTACT","613-792-1222","1","mlegacy@thechi.ca",{"name":80,"role":75,"phone":76,"phoneExt":77,"email":81},"Dugald Seely","dseely@thechi.ca",[83,99],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"The Centre for Health Innovation","RECRUITING","Ottawa","Ontario","K2P 0M7","Canada","CA",{"type":92,"coordinates":93},"Point",[94,95],-75.69812,45.41117,{"lat":95,"lon":94},[98],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},{"facility":100,"status":85,"city":101,"state":87,"zip":102,"country":89,"countryCode":90,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Canadian College of Naturopathic Medicine - Integrative Cancer Centre","Toronto","M2K 1E2",{"type":92,"coordinates":104},[105,106],-79.39864,43.70643,{"lat":106,"lon":105},[109],{"name":110,"role":75,"phone":111,"phoneExt":112,"email":113},"Daniel Lander","416-498-1255","280","dlander@ccnm.edu",{"type":115,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100540947",false,"NCT06323473","Maitake for Integrative Cancer Care","Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy","Inclusion Criteria:\n\n1. Adults (≥18 years of age)\n2. Confirmed cancer diagnosis through biopsy or radiologic imaging\n3. Undergoing systemic treatment with either chemotherapy or CD4\u002F6 inhibitors\n4. Currently receiving cancer treatment in Ontario, Canada\n\nExclusion Criteria:\n\n1. Hematologic cancers\n2. Previously received any mushroom supplement within 6 months prior to enrolment\n3. Allergy to mushrooms or mushroom products\n4. Diagnosis of diabetes\n5. Currently taking hypoglycemic or anticoagulant medications\n6. Currently receiving immune checkpoint inhibitors\n7. Unable to attend in in-person visits in either Ottawa or Toronto\n8. Any reason which, under the discretion of the Qualified Investigator or delegate, would preclude the patient from participating","ALL","18 Years",{"count":125,"type":126},40,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","Maitake is an edible mushroom that is used for both its nutritional and medicinal properties. Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators aim to measure if Maitake has any immunomodulatory effects when given alongside conventional systemic cancer therapy.",[132],"Cancer",[134,66,135,136,137,138],"Chemotherapy","Integrative Care","Integrative Medicine","Targeted Therapy","Neutrophil","2026-01-22",{"date":141,"type":142},"2026-01-23","ACTUAL",{"date":144,"type":142},"2024-10-15",{"date":146,"type":126},"2026-05-15",{"name":5,"class":6},2]