[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426141":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":16,"armGroups":38,"interventions":60,"overallOfficials":100,"centralContacts":105,"locations":110,"responsibleParty":127,"collaborators":16,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":16,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":16,"enrollmentInfo":138,"targetDuration":16,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":16,"overallStatus":112,"whyStopped":16,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Fred Hutchinson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Study participation rates","The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals.","Assessed at consenting",[14,18,20,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Number of days receiving any amount of fiber",null,"Up to 90 days following treatment",{"measure":19,"description":16,"timeFrame":17},"Number of days receiving at least 10 grams of fiber",{"measure":21,"description":16,"timeFrame":17},"Number of days receiving at least 25 grams of fiber",{"measure":23,"description":24,"timeFrame":17},"Tolerance of initiating and maintaining oral fiber intake","Tolerance of initiating and maintaining oral fiber intake (or via enteral nutrition) will be calculated as delivery of the intended amount on each day that nutritional supplementation was indicated.",{"measure":26,"description":27,"timeFrame":17},"Level of comfort\u002Fdistress attributed to initiating and maintaining oral fiber intake","The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated.",{"measure":29,"description":30,"timeFrame":17},"Incidence of adverse events","Will assess safety including diarrhea, abdominal pain, bloating.",{"allocation":32,"interventionModel":33,"interventionModelDescription":16,"primaryPurpose":34,"observationalModel":16,"timePerspective":16,"maskingInfo":35},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":36,"maskingDescription":16,"whoMasked":16},"NONE","OUTLINE:\n\nCurrent study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study.\n\nPrevious study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms.\n\nPrevious Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.\n\nPrevious Arm II: Patients received standard of care nutritional support.\n\nAfter completion of study treatment, patients are followed up at days 42, 60 and 90 days post transplant.",[39,46,52],{"label":40,"type":41,"description":42,"interventionNames":43},"Arm I (enteral nutrition) [Discontinued in January 2024]","EXPERIMENTAL","Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.",[44,45],"Dietary Supplement: Kate Farms 1.0","Other: Survey Administration",{"label":47,"type":48,"description":49,"interventionNames":50},"Arm II (standard of care) [Discontinued in January 2024]","ACTIVE_COMPARATOR","Patients receive standard of care nutritional support.",[51,45],"Dietary Supplement: Standard of Care Nutritional Support",{"label":53,"type":41,"description":54,"interventionNames":55},"Supportive care (Fiber) [Current study activity]","Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.",[45,56,57,58,59],"Dietary Supplement: Dietary Supplement","Procedure: Biospecimen Collection","Other: Electronic Health Record Review","Other: Fiber and Dietary Assessments",[61,68,77,81,89,94,97],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"DIETARY_SUPPLEMENT","Kate Farms 1.0","Given enteral nutrition via nasoenteric feeding",[40],[67],"Polymeric Enteral Nutrition Formula",{"type":62,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Standard of Care Nutritional Support","Given standard of care, which may be parenteral nutrition",[47],[73,74,75,76],"hyperalimentation","parenteral nutrition","Total Parenteral Nutrition","TPN",{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":16},"Survey Administration","Ancillary studies",[40,47,53],{"type":62,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"Dietary Supplement","Receive fiber supplementation orally or enterally",[53],[86,87,88],"nutritional supplement","supplemental nutrition","Supplements",{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":16},"PROCEDURE","Biospecimen Collection","Undergo collection of blood and stool samples",[53],{"type":6,"name":95,"description":79,"armGroupLabels":96,"otherNames":16},"Electronic Health Record Review",[53],{"type":6,"name":98,"description":79,"armGroupLabels":99,"otherNames":16},"Fiber and Dietary Assessments",[53],[101],{"name":102,"affiliation":103,"role":104},"David Fredricks","Fred Hutch\u002FUniversity of Washington Cancer Consortium","PRINCIPAL_INVESTIGATOR",[106],{"name":102,"role":107,"phone":108,"phoneExt":16,"email":109},"CONTACT","206-667-1935","dfredric@fredhutch.org",[111],{"facility":103,"status":112,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"RECRUITING","Seattle","Washington","98109","United States","US",{"type":119,"coordinates":120},"Point",[121,122],-122.33207,47.60621,{"lat":122,"lon":121},[125,126],{"name":102,"role":107,"phone":108,"phoneExt":16,"email":109},{"name":102,"role":104,"phone":16,"phoneExt":16,"email":16},{"type":128,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100426141","sustained-oral-fiber-supplementation-for-patients-undergoing-donor-stem-cell-transplantation-for-hematological-malignancies-100426141",false,"NCT04829136","Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies","Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies","Inclusion Criteria:\n\n* Able to provide written informed consent prior to initiation of any study procedures\n* Any diagnosed hematological malignancy\n* At least 18 years of age\n* Planned treatment at Fred Hutchinson Cancer Center and\u002For University of Washington Medical Center\n\nExclusion Criteria:\n\n* Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team\n* Pregnant or breastfeeding. Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart","ALL","18 Years",{"count":139,"type":140},100,"ESTIMATED","INTERVENTIONAL",[143],"NA","This clinical trial examines sustained oral fiber supplementation for patients undergoing treatment for hematological malignancies. Patients undergoing cancer treatment, including donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and\u002For improve gut function in patients undergoing treatment for hematological malignancies.",[146],"Hematopoietic and Lymphatic System Neoplasm","2026-08-28",{"date":149,"type":150},"2026-09-01","ACTUAL",{"date":152,"type":150},"2022-06-22",{"date":154,"type":140},"2027-12-31",{"name":5,"class":6},1]