[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545299":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":11,"studyPopulation":11,"armGroups":31,"interventions":38,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":81,"collaborators":11,"id":83,"slug":11,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":11,"studyType":96,"phases":97,"briefSummary":98,"conditions":99,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea",null,"During standard of care Short-course radiotherapy and total neoadjuvant therapy, up to approximately 1 year",[14,17,20,23],{"measure":15,"description":11,"timeFrame":16},"Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema","approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention",{"measure":18,"description":11,"timeFrame":19},"Absolute and relative change from baseline of circulating non-essential amino acids","from baseline up to approximately 8 weeks after SCRT-TNT with NEAAR medical food intervention",{"measure":21,"description":11,"timeFrame":22},"Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food","approximately 4 weeks after SCRT with NEAAR medical food intervention",{"measure":24,"description":11,"timeFrame":25},"molecular ctDNA response.","approximately 4 weeks after SCRT with NEAAR medical food intervention and 8 weeks post SCRT-TNT with NEAAR medical food intervention.",{"allocation":27,"interventionModel":28,"interventionModelDescription":11,"primaryPurpose":6,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"NA","SINGLE_GROUP",{"masking":30,"maskingDescription":11,"whoMasked":11},"NONE",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"Nonessential Amino Acid Restriction (NEAAR) Medical Food","EXPERIMENTAL","This is a single arm study in which all subjects will receive NEAAR medical food.",[37],"Other: NEAAR Medical Food",[39],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"NEAAR Medical Food","Standardized non-essential amino acid restricted medical food.",[33],[44],{"name":45,"affiliation":5,"role":46},"Richard R Tuli, MD","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":11,"email":51},"CONTACT","813 844 7585","rtuli@usf.edu",{"name":53,"role":49,"phone":54,"phoneExt":11,"email":55},"Keira O'Connor","813 844 8486","keiraoconnor@usf.edu",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Tampa","Florida","33606","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-82.45843,27.94752,{"lat":68,"lon":67},[71,75,79],{"name":72,"role":49,"phone":73,"phoneExt":11,"email":74},"Jennifer Burgess, MS","434-806-6445","jburgess@tgh.org",{"name":76,"role":49,"phone":77,"phoneExt":11,"email":78},"Veronique Perry, MSHA","2549873658","vperry@tgh.org",{"name":80,"role":46,"phone":11,"phoneExt":11,"email":11},"Richard Tuli, MD",{"type":82,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100545299",false,"NCT06380101","Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)","Prospective, Single Arm IIA Study to Evaluate the Feasibility of a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food in Combination With Total Neoadjuvant Therapy (TNT) for Management of Locally Advanced Rectal Cancer (LARC) NEAAR-LARC","NEAAR-LARC","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the rectum\n* Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI\n* Eligible for total mesorectal excision\n* No evidence of distant metastasis\n* No prior pelvic radiation therapy\n* No prior chemotherapy\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Patients unable to undergo MRI\n* Other anticancer or experimental therapy\n* Body mass index (BMI) \\\u003C18.5 kg\u002Fm2 or \\>40 kg\u002Fm2\n* Serious or refractive cachexia or anorexia\n* Insulin-dependent diabetes Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®) Patients with a condition where high-fat or fatty food is contraindicated History of confirmed food allergy Active wound or skin graft that would require a significant increase in protein requirements for skin integrity and healing","ALL","18 Years","100 Years",{"count":94,"type":95},30,"ESTIMATED","INTERVENTIONAL",[27],"This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.",[100],"Rectal Cancer","2025-12-03",{"date":103,"type":104},"2025-12-10","ACTUAL",{"date":106,"type":104},"2023-09-08",{"date":108,"type":95},"2027-06",{"name":5,"class":6},1]